PulseRider Aneurysm Neck Reconstruction Device 201-DRecalls & reported problems

Summary

The FDA's MAUDE database contains 74 adverse event reports that list this exact device (DI 00859030005154), received between Nov 22, 2017 and Jan 30, 2024 — classified as 2 deaths, 53 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (11 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 74 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 30, 2024Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, THIS WAS A STENT ASSISTED COIL EMBOLIZATION USING A PULSERIDER T, 3MM, 8MM ARCH ( 201D), TO TREAT A BASILAR ARTERY ANEURYSM. THE PULSERIDER WAS DEPLOYED AT THE TARGET LESION, AND THE ANEURYSM WAS COMPLETELY EMBOLIZED WITH 10 COILS. (PRODUCT NAME UNKNOWN). THE PULSERIDER WAS ATTEMPTED TO BE DETACHED USING THE PULSERIDER'S DETACHMENT SYSTEM AND CONFIRMED THAT THE DETACHMENT SYSTEM INDICATED THAT THE IMPLANT HAD BEEN DETACHED. THEN THE MICROCATHETER WAS ADVANCED, AND THE MICROCATHETER RE-SHEATHED THE PROXIMAL MARKER ON ONE LEG OF THE IMPLANT. ALSO, WHEN THE PULSERIDER DELIVERY WIRE WAS PULLED, THE IMPLANT MOVED SLIGHTLY. REPLACED THE DETACHMENT SYSTEM WITH ANOTHER NEW ONE AND PERFORMED DETACHMENT PROCESS AGAIN, THE DETACHMENT SYSTEM INDICATED A SIGN THAT DETACHMENT WAS COMPLETE, AND THE DETACHMENT PROCESS WAS INTERRUPTED. THE PULSERIDER HAD BEEN DETACHED BY REPEATED PUSHING AND PULLING OF THE DELIVERY WIRE JUST ENOUGH TO KEEP THE PULSERIDER IMPLANT IN PLACE. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS TO THE PATIENT. THERE WERE NO COMPLICATIONS TO THE PATIENT. IT IS UNKNOWN IF A CONTINUOUS FLUSH WAS PERFORMED. THE PHYSICIAN COMMENTED THAT SUCH INCOMPLET

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18606196 ↗
• InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT ON (B)(6) 2023, THE PATIENT WITH A HISTORY OF CEREBRAL INFARCTION, VERTEBRAL ARTERY STENOSIS, AND ON SINGLE ANTIPLATELET THERAPY (SAPT) UNDERWENT A STENT-ASSISTED COIL EMBOLIZATION USING A 2.7 TO 3.5 MM, 8 MM, T SHAPE PULSERIDER ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / 3077440212) FOR AN UNRUPTURED BIFURCATING CEREBRAL ANEURYSM AT THE BASILAR ARTERY (BA) TOP UNDER GENERAL ANESTHESIA. TO PRESERVE THE RIGHT POSTERIOR CEREBRAL ARTERY (PCA), A HYBRID ORIENTATION IMPLANTATION WAS ATTEMPTED SEVERAL TIMES, BUT THE ORIGIN OF THE LEFT PCA AND THE SUPERIOR CEREBELLAR ARTERY (SCA) WERE CLOSE TO EACH OTHER AND THE RIGHT PCA WAS NARROW. THE INTENDED HYBRID ORIENTATION IMPLANT PLACEMENT WAS RIGHT EXTRA AND LEFT INTRA, BUT IT WAS DIFFICULT TO PLACE THE IMPLANT AND AS A RESULT, THE PULSERIDER WAS IMPLANTED WITH THE INTRA ORIENTATION. COIL EMBOLIZATION WAS PERFORMED WITH SEVERAL AXIUM FRAME (MEDTRONIC) AND AXIUM PRIME 3D (MEDTRONIC) COILS. THE PROCEDURE WAS COMPLETED WITH CONFIRMATION OF BLOOD FLOW INTERRUPTION INTO THE TARGET ANEURYSM. THE MICROCATHETER USED WAS A PROWLER SELECT PLUS WITH CONTINUOUS FLUSH MAINTAINED THROUGH IT. AT A FOLLOW-UP ON

  Patient problems: Ischemia Stroke

  MAUDE report 18145805 ↗
• InjuryNov 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS COMPLAINT IS FROM A LITERATURE SOURCE. TITLE: IN-STENT STENOSIS AFTER STENTING THE PULSERIDER FOR A MIDDLE CEREBRAL ARTERY ANEURYSM: A CASE REPORT. AUTHORITY: SAKATA M, TAJIMA Y, KUBOTA M, IWADATE Y. IN-STENT STENOSIS AFTER STENTING THE PULSERIDER FOR A MIDDLE CEREBRAL ARTERY ANEURYSM: A CASE REPORT. RADIOL CASE REP. 2023 JUL 22;18(10):3453-3456. DOI: 10.1016/J.RADCR.2023.07.010. PMID: 37502481; PMCID: PMC10369375. THE 40-YEAR-OLD FEMALE PATIENT WITH AN UNRUPTURED ANEURYSM IN THE MIDDLE CEREBRAL ARTERY UNDERWENT A STTENT-ASSISTED COIL EMBOLIZATION WITH PULSED RIDER AND PROWLER SELECT WAS PERFORMED TO TREAT AN UNRUPTURED ANEURYSM IN THE BIFURCATION OF THE LEFT MIDDLE CEREBRAL ARTERY M2. PATIENTS RECEIVED DUAL ANTIPLATELET THERAPY WITH ASPIRIN 100 MG AND PRASUGREL 3.75 MG FOR 10 DAYS BEFORE PROCEDURE. DURING PROCEDURE, SYSTEMIC HEPARINIZATION WAS PROVIDED. ANGIOGRAPHY REVEALED AN ANEURYSM BETWEEN THE SUPERIOR AND INFERIOR TRUNKS OF THE MIDDLE CEREBRAL ARTERY M2. THE SIZE MEASUREMENTS OF THE ANEURYSM WERE AS FOLLOWS: DIAMETER: 5.7 MM, NECK: 4.4 MM, HEIGHT: 5.6 MM, DOME-TO-NECK AND ASPECT RATIO: 1.30 AND 1.27, RESPECTIVELY. A 6-FRENCH FUBUKI INTRODUCER SHEATH (ASAHI INTEC INC.) WA

  Patient problems: Perforation of Vessels; Restenosis

  MAUDE report 18135084 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FORM A PERSONAL INTERACTION THAT ON (B)(6) 2023 A PATIENT UNDERWENT ENDOVASCULAR EMBOLIZATION OF A BASILAR ARTERY (BA) TOP ANEURYSM USING A PULSERIDER T, 3MM, 8MM ARCH (CATALOG 201D/LOT 3078569808). PER DETAILS OF THE PROCEDURE, LESION SITE WAS ACCESSED FROM THE RIGHT RADIAL ARTERY VIA THE RIGHT VERTEBRAL ARTERY (VA). THE PULSERIDER WAS IMPLANTED IN THE FIRST ATTEMPT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY (DETAILS ON COILS USED ARE CURRENTLY UNKNOWN). IT WAS STATED THAT, LATER, ON REVIEWING THE POSTOPERATIVE CT SCAN, A PARTIAL INFARCTION IN THE CEREBELLUM WAS FOUND. THE PATIENT IS HOSPITALIZED AS OF ONE WEEK AFTER THE SURGERY. OTHER CONCOMITANT DEVICES USED WERE A 6FR 25CM SHEATH INTRODUCER (UNKNOW MANUFACTURER), 6FR 115CM SOFIA (MICROVENTION) GUIDING CATHETER, CHIKAI 14 (ASAHI INTECC), GUIDEWIRE, PROWLER SELECT PLUS MICROCATHETER. IT WAS MENTIONED THAT CONTINUOUS FLUSH WAS DONE AND THAT THE DEVICE WAS USED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). IT WAS REFERRED THAT ¿THE INFARCT LESION FOUND WAS LIKE LACUNAR INFARCT. THIS MAY NOT BE RELATED TO THE ISSUE, BUT PATIENT HUSBAND WAS FOUND TO BE COVID-POSITIVE AFTER THE SURGERY¿ AND A ¿COVID EPIDEMIC OCCURRED

  Patient problems: Ischemia Stroke

  MAUDE report 17106318 ↗
• MalfunctionJun 5, 2023Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, THIS WAS A COIL EMBOLIZATION PROCEDURE FOR UNRUPTURED BASILAR TIP ANEURYSM. THE PROCEDURE WAS PERFORMED BY DOUBLE CATHETER TECHNIQUE. A PULSERIDER T, 3MM, 8MM ARCH (201D, 3078569818) WAS USED WITH THE PROWLER SELECT PLUS 150/5CM MICROCATHETER (606S255X, 30883124), WHILE THE PHENOM17 WAS USED FOR THE COIL. AFTER THE PROWLER SELECT PLUS WAS INSERTED TO THE ANEURYSM, THE PULSERIDER WAS ATTEMPTED TO INSERTED, BUT THERE WAS A RESISTANCE, SO THE PULSERIDER WAS WITHDRAWN. THE ISSUE WAS RESOLVED BY REPLACING BOTH THE PULSERIDER AND THE PROWLER SELECT PLUS TO NEW ONES. THE COIL EMBOLIZATION PROCEDURE WAS COMPLETED WITH SUCCESSFUL PULSERIDER IMPLANTATION. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS NOT DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17058135 ↗
• InjuryApr 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING A BIFURCATING ANEURYSM ON THE MIDDLE CEREBRAL ARTERY (MCA), THE PROCEDURE WAS STARTED USING A PROWLER SELECT PLUS MICROCATHETER AND AN SL-10® MICROCATHETER (STRYKER) WITH A 7FR SHUTTLE® LONG SHEATH (COOK MEDICAL), AND TWO (2) GUIDEPOST® DISTAL ACCESS CATHETER (TOKAI MEDICAL). A CONTINUOUS FLUSH WAS MAINTAINED / CONDUCTED. THE PROWLER SELECT PLUS MICROCATHETER WAS DELIVERED TO THE M1 SEGMENT PROXIMAL TO THE ANEURYSM, AND A PULSERIDER Y SHAPE, 8MM , 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (301D / LOT# UNKNOWN) WAS USED. AFTER THE PULSERIDER Y SHAPE, 8MM ANRD WAS SUCCESSFULLY DEPLOYED, THE SL-10® MICROCATHETER WAS INSERTED INTO THE ANEURYSM AND COILING WAS ATTEMPTED. THE 2.5MM G3 COIL (CATALOG AND LOT NUMBER UNKNOWN) WAS USED AS THE FIRST COIL; IT COULD NOT DEPLOY PROPERLY AND WAS REMOVED. THE PULSERIDER Y SHAPE, 8MM ANRD WAS ALSO REMOVED AND REPLACED WITH ANOTHER PULSERIDER ANRD OF A DIFFERENT SHAPE. THE PROWLER SELECT PLUS MICROCATHETER WAS INSERTED INTO THE M2 SEGMENT, AND A PULSERIDER T SHAPE, 8MM , 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / 3077440202) WAS A

  Patient problems: Intracranial Hemorrhage

  MAUDE report 16840075 ↗
• InjuryMar 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH A PERSONAL INTERACTION THAT A PATIENT OF UNKNOWN AGE AND SEX (NO DEMOGRAPHIC INFORMATION WAS PROVIDED) UNDERWENT A STENT-ASSISTED ENDOVASCULAR COIL EMBOLIZATION OF A MIDDLE CEREBRAL ARTERY (MCA), ANEURYSM WITH A 3MM 8MM ARCH PULSERIDER T (201D/UNKNOWN LOT). IT WAS STATED, THAT THE COIL EMBOLIZATION WAS COMPLETED WITHOUT PROBLEMS. IT WAS FURTHER MENTIONED THAT ¿THE PATIENT HAS BEEN UNDER MONITORED AND STENOSIS AT THE MCA WAS CONFIRMED¿. IT WAS REFERRED THAT ¿POST-PROCEDURE, THERE WERE NO SYMPTOMS, AND THE PATIENT HAS BEEN STABLE¿. CONTINUOUS FLUSH WAS DONE. A CONCOMITANT DEVICE MENTIONED WAS A PROWLER SELECT PLUS MICROCATHETER. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF COMPLAINT INITIATION.

  Patient problems: Restenosis

  MAUDE report 16618817 ↗
• InjuryMar 3, 2023Difficult to Advance; Difficult to Advance

  IT WAS REPORTED BY A PERSONAL INTERACTION THAT A 79-YEAR-OLD FEMALE PATIENT UNDERWENT AN ENDOVASCULAR EMBOLIZATION USING A PULSERIDER T, 3MM, 8MM ARCH AT THE MIDDLE CEREBRAL ARTERY (MCA). PER THE EVENT DESCRIPTION, THE COMPLAINT PULSERIDER WAS USED AS A ¿TORQUE¿ PRIOR TO THE PHYSICIAN DECIDING THE POSITION FOR THE IMPLANT. HOWEVER, THERE WAS RESISTANCE. THE COMPLIANT DEVICE WAS IMPLANTED AS ¿EXTRA¿, AND CONTRAST WAS INJECTED TO CONFIRM THERE WAS A RUPTURE. A CATHETER FOR THE COIL (PHENOM) WAS INSERTED AND COILING WAS PERFORMED. THERE WAS NO BLEEDING CONFIRMED BY FINAL ANGIOGRAPHY AND THE PROCEDURE WAS COMPLETED. OTHER CONCOMITANT DEVICES USED WERE A SYNCHRO 2 GUIDEWIRE (STRYKER), AN 80CM FUBUKI 6FR GS GUIDING CATHETER (ASAHI INTECC), A PROWLER SELECT PLUS MICROCATHETER AND A VECTA71 INTERMEDIATE CATHETER (STRYKER). ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023. SUMMARY OF ADDITIONAL INFORMATION PROVIDED: THE PATIENT DID NOT FULLY RETURN TO CONSCIOUSNESS BUT WAS ABLE TO RAISE THEIR HANDS. THE PATIENT GRADUALLY RECOVERED. INITIALLY, DEPLOYMENT IN ANTEGRADE WAS ASSUMED, BUT IT WAS CHANGED TO DEPLOYMENT IN RETROGRADE ACCORDING TO THE BEHAVIOR OF THE COMPLAINT PULSERIDER. IT WAS AN

  Patient problems: Ruptured Aneurysm

  MAUDE report 16478984 ↗
• InjuryFeb 28, 2023Positioning Failure; Positioning Failure

  IT WAS REPORTED FROM A PERSONAL INTERACTION THAT A PATIENT UNDERWENT AN ENDOVASCULAR EMBOLIZATION PROCEDURE OF A RIGHT MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM USING A PULSERIDER T, 3MM, 8MM ARCH (201D/3077900504) ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) ON (B)(6) 2023 AND EXPERIENCED AN INTRA-OPERATIVE ANEURYSM RUPTURE. DETAILS OF THE PROCEDURE: THE PHYSICIAN PUNCTURED THE RIGHT FEMORAL ARTERY AND GUIDED A 6F SHUTTLE GS 80CM SHEATH INTO THE RIGHT INTERNAL CAROTID ARTERY (ICA). A 3D IMAGE WAS TAKEN AND A 6F BENCHMARK (PENUMBRAINC) CATHETER WAS DELIVERED TO THE FRONT OF CAROTID SIPHON UNDER A SHOURYU BALLOON CATHETER GUIDANCE. NEXT A SL-10 45O (STRYKERNEUROVASCULAR) MICROCATHETER (FOR COIL DELIVER) WAS DELIVERED TO NEAR THE TERMINUS SEGMENT OF THE ICA AND A PROWLER SELECT PLUS MICROCATHETER WAS DELIVERED TO THE M1 SEGMENT OF THE RIGHT MCA. THE COMPLAINT PULSE RIDER WAS INSERTED INTO THE PROWLER SELECT PLUS MICROCATHETER AND DEPLOYED CLOSE TO THE ANEURYSM. IT WAS MENTIONED THAT THE COMPLAINT DEVICE WAS USED AS PER THE INSTRUCTIONS FOR USE (IFU). WHEN THE ARCH PART WAS ABOUT HALF PROTRUDED, THE INFERIOR BRANCH WAS LOCATED OUTSIDE THE ANEURYSM, AND THE OPPOSITE SIDE WAS LOCATED INSIDE T

  Patient problems: Ruptured Aneurysm

  MAUDE report 16452706 ↗
• InjuryFeb 22, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE EVENT WAS REPORTED VIA A POST-MARKET STUDY (PMS), THE 49-YEAR-OLD PATIENT UNDERWENT A PULSERIDER-ASSISTED ENDOVASCULAR COIL EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED ANEURYSM LOCATED IN THE MIDDLE PORTION OF THE ANTERIOR COMMUNICATING ARTERY (ACOMA) USING A PULSERIDER T SHAPE, 8MM , 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / LOT# UNKNOWN) ON (B)(6) 2022. THE DIMENSIONS OF THE TARGET ANEURYSM ARE AS FOLLOWS: HEIGHT 11.3MM, MAXIMUM ANEURYSM DIAMETER 13.1MM, DOME WIDTH 12.9MM, NECK DIAMETER 6.4MM, DOME TO NECK RATIO 2. THE PARENT VESSEL DIAMETER WAS 2.7MM, THE (2) BRANCHING VESSEL DIAMETER WAS 2.2MM AND (3) BRANCHING VESSEL DIAMETER WAS 1.8MM. THE PULSERIDER ANRD WAS DELIVERED VIA A PROWLER SELECT PLUS MICROCATHETER (CATALOG / LOT# UNKNOWN) AND SUCCESSFULLY IMPLANTED IN A HYBRID ORIENTATION WITH ONE OF THE WINGS INSIDE THE ANEURYSM. THE COIL MASS WAS SUCCESSFULLY MAINTAINED AND THE PROCEDURE WAS COMPLETED. IT WAS NOT KNOWN IF A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. ON 31-JAN-2023, A ¿MIGRATION / DEVIATION / INSUFFICIENT EMBOLIZATION OF EMBOLIC COILS OCCURRED.¿ THERE WAS A RECURRENCE OF ANEURYSM DUE TO COIL COMPACTION. THERE WAS NO NEGAT

  Patient problems: Aneurysm

  MAUDE report 16419657 ↗
• InjuryFeb 22, 2023Patient-Device Incompatibility; Patient-Device Incompatibility

  THE EVENT WAS REPORTED VIA A POST-MARKET STUDY (PMS); ON (B)(6) 2021, A 57-YEAR-OLD PATIENT UNDERWENT A PULSERIDER-ASSISTED ENDOVASCULAR EMBOLIZATION PROCEDURE TO TREAT AN UNRUPTURED MIDDLE CEREBRAL ARTERY (MCA) ANEURYSM WITH THE FOLLOWING DIMENSIONS: HEIGHT 8.9MM, MAXIMUM ANEURYSM DIAMETER 9.5MM, DOME WIDTH 9.2MM, NECK DIAMETER 4.5MM, DOME TO NECK RATIO 2. THE PARENT VESSEL DIAMETER WAS 3.1MM, THE (2) BRANCHING VESSEL DIAMETER WAS 2.9MM AND (3) BRANCHING VESSEL DIAMETER WAS 2.1MM. A PULSERIDER T SHAPE, 8MM , 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / 30480552) WAS SUCCESSFULLY IMPLANTED AT THE TARGET POSITION IN A PARTIAL INTRAANEURYSMAL POSITION WITH ONE ¿WING¿ INSIDE THE ANEURYSM. THE COIL MASS WAS SUCCESSFULLY MAINTAINED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PRODUCT MALFUNCTION REPORTED. ON 18-APR-2022, IT WAS REPORTED THAT A ¿MIGRATION/DEVIATION/INSUFFICIENT EMBOLIZATION OF EMBOLIC COILS OCCURRED. COIL COMPACTION INCREASED ANEURYSMAL BLOOD FLOW.¿ THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT.

  Patient problems: Aneurysm

  MAUDE report 16419035 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT UNDERWENT AN ENDOVASCULAR EMBOLIZATION PROCEDURE; A PULSERIDER T SHAPE, 8MM , 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / LOT# UNKNOWN) WAS USED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED ISCHEMIA. THE LOCATION OF THE TARGET LESION IS UNKNOWN. IT WAS ALSO NOT KNOWN IF A CONTINUOUS FLUSH WAS MAINTAINED. IT WAS DOCUMENTED IN THE EVENT DESCRIPTION OF THE COMPLAINT, ¿CONFIRMED BY MATERIALS OF THE COMPLAINT PULSE RIDER WHICH WAS REQUESTED TO PHYSICIAN.¿ LIMITED INFORMATION WAS AVAILABLE AT THE TIME OF THE COMPLAINT INITIATION.

  Patient problems: Transient Ischemic Attack

  MAUDE report 16131849 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT A PATIENT UNDERWENT AN ENDOVASCULAR EMBOLIZATION PROCEDURE; A PULSERIDER T SHAPE, 8MM , 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / LOT# UNKNOWN) WAS USED. IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLEEDING. THE LOCATION OF THE TARGET LESION IS UNKNOWN. IT WAS ALSO NOT KNOWN IF A CONTINUOUS FLUSH WAS MAINTAINED. IT WAS DOCUMENTED IN THE EVENT DESCRIPTION OF THE COMPLAINT, ¿CONFIRMED BY MATERIALS OF THE COMPLAINT PULSE RIDER WHICH WAS REQUESTED TO PHYSICIAN.¿ LIMITED INFORMATION WAS AVAILABLE AT THE TIME OF THE COMPLAINT INITIATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation of Vessels

  MAUDE report 16131768 ↗
• InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM A PERSONAL INTERACTION THAT A PATIENT UNDERWENT ENDOVASCULAR EMBOLIZATION USING A PULSERIDER T, 3 MM, 8 MM ARCH (PRODUCT CODE: 201D) AND EXPERIENCED BLEEDING. PER THE EVENT DESCRIPTION, THE COMPLAINT WAS ¿CONFIRMED BY MATERIALS OF THE COMPLAINT PULSE RIDER WHICH WAS REQUESTED TO PHYSICIAN¿. THE LOCATION OF THE LESION IS UNKNOWN. CONTINUOUS FLUSH IS UNKNOWN. OTHER CONCOMITANT DEVICE (S) IS UNKNOWN. NO FURTHER DETAILS WERE PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 04-JAN-2023. SUMMARY OF ADDITIONAL INFORMATION PROVIDED: THE EVENT DESCRIPTION SHOULD BE UPDATED TO ¿HEMORRHAGE WAS OBSERVED WITH THE PATIENT¿.

  Patient problems: Intracranial Hemorrhage

  MAUDE report 16122144 ↗
• DeathDec 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED FROM A PERSONAL INTERACTION THAT DURING AN ENDOVASCULAR EMBOLIZATION OF AN ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM ON A FEMALE PATIENT PERFORMED ON (B)(6) 2022, WHILE DEPLOYING A PULSERIDER T, 3MM, 8MM ARCH (CATALOG 201D/LOT 3077900503) ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD), A PERFORATION OF ACOM BRANCH VESSELS AND SUBARACHNOID HEMORRHAGE HAS OCCURRED. IT WAS DESCRIBED THAT A PHENOM 21 MICROCATHETER WAS DELIVERED TO THE VICINITY OF THE ANEURYSM NECK, AND THE COMPLAINT PULSE RIDER WAS DEPLOYED. AT FIRST, HYBRID PLACEMENT WAS PLANNED, BUT WHEN THE COMPLAINT DEVICE WAS REPEATEDLY TAKEN IN AND OUT BETWEEN THE ANTERIOR CEREBRAL ARTERY (ACA) A2 SEGMENT AND THE ACOM, THE PROCEDURE WAS CHANGED TO PROCEED WITH AN EXTRA-ANEURYSM PLACEMENT. WHEN CONTRAST IMAGING WAS DONE, IT WAS CONFIRMED THAT BLEEDING OCCURRED FROM AROUND THE PULSE RIDER LEAFLET OF THE ACOM. AFTER THAT, REVERSAL OF THE HEPARIN WAS PERFORMED AND WAITED FOR 5 MINUTES. IT WAS STATED THAT BOTH ANEURYSM AND ACOM BLEEDING POINT WERE EMBOLIZED BY INTRODUCING A MICROCATHETER (UNKNOWN DEVICE DETAILS) FOR COIL (UNKNOWN DEVICE DETAILS) DEPLOYMENT. IT WAS REFERRED THAT COIL EMBOLIZATION FOR THE ANEURYSM AND TH

  Patient problems: Intracranial Hemorrhage; Perforation of Vessels

  MAUDE report 16003821 ↗
• MalfunctionDec 14, 2022Positioning Failure; Difficult to Advance; Material Twisted/Bent; Positioning Failure; Difficult to Advance; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A STENT-ASSISTED CEREBRAL COIL EMBOLIZATION PROCEDURE TARGETING AN UNRUPTURED ANEURYSM ON THE BASILAR ARTERY, A PULSERIDER T SHAPE, 8MM , 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / 3077440203) WAS USED. THE COMPLAINT PULSERIDER WAS DELIVERED VIA A PROWLER SELECT PLUS (STR) MICROCATHETER (CATALOG & LOT# UNKNOWN). THE POSITION OF THE PULSERIDER ANDR WAS ADJUSTED BY APPLYING TORQUE, BUT THE POSITION DID NOT FIT. THE PULSERIDER ANRD WAS REMOVED ONCE AND RE-DELIVERED AGAIN, BUT THERE WAS AN INTENSIVE RESISTANCE FELT WHEN THE COMPLAINT DEVICE WAS ADVANCING THROUGH THE TORTUOUS PART OF THE VERTEBRAL ARTERY. THE POSITION WAS ADJUSTED BY APPLYING TORQUE AGAIN, BUT THE PULSERIDER ANRD WAS NOT ABLE TO BE IMPLANTED. IT WAS REPORTED THAT THE PHYSICIAN FELT AN INTENSE RESISTANCE AND THE ENTIRE SYSTEM SEEM TO ¿SLIP OFF.¿ THE PULSERIDER ANRD WAS REPLACED WITH ANOTHER STENT, A NEUROFORM ATLAS® STENT SYSTEM (STRYKER); IT WAS IMPLANTED. COIL EMBOLIZATION WAS PERFORMED AND THE PROCEDURE WAS COMPLETED WITHOUT ANY NEGATIVE PATIENT IMPACT. THE COMPLAINT INDICATED THAT THERE WAS CONTINUOUS FLUSH MAINTAINED THROUGH THE MICROCATHETER. OTHE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15982361 ↗
• InjuryDec 9, 2022Positioning Failure; Migration; Positioning Failure; Migration

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 50-YEAR-OLD FEMALE PATIENT UNDERWENT A STENT-ASSISTED COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE MIDDLE CEREBRAL ARTERY (MCA), A PULSERIDER T SHAPE, 8MM , 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / 3077440213) WAS USED. AFTER DELIVERY OF AN 8FR ASAHI FUBUKI GUIDE CATHETER (ASAHI INTECC) TO THE ORIGIN OF THE INTERNAL CAROTID ARTERY, A SOFIA¿ 6F INTERMEDIATE CATHETER (MICROVENTION), A PHENOM¿ 21 MICROCATHETER (MEDTRONIC) FOR THE DELIVERY OF THE PULSERIDER ANRD, AND AN SL-10® MICROCATHETER (STRYKER) FOR COIL EMBOLIZATION WERE DELIVERED TO THE M1 SEGMENT OF THE MCA. INFORMATION RELATED TO THE ANEURYSM DIMENSIONS AND CHARACTERISTICS WERE NOT PROVIDED. TO DEPLOY THE PULSERIDER ANRD, THE PHENOM 21 MICROCATHETER WAS DELIVERED TO THE PROXIMAL ANEURYSM AND THE PULSERIDER ANRD WAS RETROGRADELY DEPLOYED. AS THE PULSERIDER ANRD FACED IMPROPER ORIENTATION, ADJUSTMENT WITH THE TORQUE DEVICE WAS REPEATED THREE TIMES. IT WAS REPORTED THAT BECAUSE THE PULSERIDER ANRD FACED PROPER ORIENTATION ON THE FOURTH TIME, THE PULSERIDER ANRD WAS DEPLOYED. ANGIOGRAPHY WAS PERFORMED TO CONFIRM WHETHER THE PULSERIDER ANRD WAS IMPLANTE

  Patient problems: Aneurysm; Intracranial Hemorrhage

  MAUDE report 15955380 ↗
• InjuryDec 9, 2022Positioning Failure; Positioning Failure

  1. OVERVIEW OF THE PROCEDURE. THIS PROCEDURE WAS A COIL EMBOLIZATION FOR CEREBRAL ANEURYSM USING THE COMPLAINT PULSE RIDER. 2. DETAILS OF THE PROCEDURE. THE COMPLAINT PULSE RIDER WAS USED FOR BA-TOP ANEURYSM. ANOTHER DEVICE (10T) WAS USED BUT DEPLOYMENT WAS DIFFICULT. THE 10 T DEVICE WAS REPLACED WITH THE COMPLAINT PULSE RIDER (8T). WHEN THE DEVICES WERE ALIGNED ANTEGRADE AGAINST BLOOD VESSEL, THE MICROCATHETER JUMPED AND ENTERED THE ANEURYSM AND PERFORATED WITH THE TIP OF THE COMPLAINT PULSE RIDER PROTRUDING. AFTER THAT, THE COMPLAINT PULSE RIDER WAS RE-SHEATHED ONCE AND ONE COIL WAS WINDED. THE COMPLAINT PULSE RIDER WAS DEPLOYED. THE MICROCATHETER WAS REINSERTED BY TRANS-CELL TECHNIQUE AND THE COIL WAS EMBOLIZED INSIDE ANEURYSM AND STOPPED BLOOD FLOW. BECAUSE THE BALLOON WAS UNABLE TO BE USED AS THE SYSTEM, EMBOLIZATION WAS IMMEDIATELY PERFORMED AND THE PROCEDURE WAS TERMINATED. 3. POST-PROCEDURE CHANGES IN THE PATIENT. POSTOPERATIVE DRAINAGE WAS PERFORMED. THE CURRENT CONDITION IS UNKNOWN AFTER DRAINAGE. THE PATIENT HAS BEEN HOSPITALIZED. CONTINUOUS FLUSH WAS DONE. THE LESION WAS THE BA. OTHER CONCOMITANT DEVICES ARE A MICROCATHETER (PROWLER SELECT PLUS) AND AN INTERMEDIATE CATH

  Patient problems: Aneurysm

  MAUDE report 15950186 ↗
• InjuryDec 8, 2022Patient-Device Incompatibility; Activation Problem; Patient-Device Incompatibility; Activation Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PULSERIDER-ASSISTED COIL EMBOLIZATION PROCEDURE TARGETING AN UNRUPTURED BASILAR ARTERY (BA) TIP ANEURYSM, THE COMPLAINT PULSERIDER, A PULSERIDER T SHAPE, 8MM , 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / 3076825513) WAS PLACED WITHOUT ANY PROBLEM. A CONCOMITANT MICROCATHETER, AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER) WAS DELIVERED TO THE TARGET ANEURYSM TO EMBOLIZE FOURTEEN (14) COILS, BUT THE PHYSICIAN ¿POINTED OUT A STRANGE FEELING WHEN INSERTING¿ THE 1.00MM X 3.00CM GALAXY G3 MINI (GLM910030 / K10700), WHICH WAS USED AS THE LAST COIL. THE COMPLAINT COIL WAS REMOVED FROM THE PATIENT AND CHECKED; IT WAS OBSERVED TO HAVE UNRAVELED. ¿IT WAS PROBABLY USED AT THE END OF COIL EMBOLIZATION, AND THEREFORE, IT WAS DIFFICULT TO FIT INTO THE ANEURYSM AND UNRAVELED OCCURRED WHEN THE COMPLAINT COIL WAS TAKEN IN AND OUT SEVERAL TIMES.¿ THE COMPLAINT COIL WAS REMOVED AND ¿IMAGED BEFORE DETACHMENT OF THE COMPLAINT PULSERIDER. BECAUSE THE COILS WERE ALSO LOCATED OUTSIDE THE PULSERIDER, THE PULSERIDER WAS DETACHED. DETACHMENT WAS SUCCESS AND DELIVERED AROUND THE LEG WITH THE PROWLER SELECT PLUS MICROCATHETER TO CONFIRM THAT T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15944885 ↗
• DeathNov 30, 2022Positioning Failure; Positioning Failure

  IT WAS REPORTED FROM A PERSONAL INTERACTION THAT DURING AN ENDOVASCULAR EMBOLIZATION OF A MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION ANEURYSM ON A FEMALE PATIENT, A PULSERIDER T, 3MM, 8MM ARCH (CATALOG 201D/LOT 3076825514) ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) WAS IMPLANTED WITH DIFFICULTY AND DEPLOYED IN A HYBRID POSITION. IT WAS ALSO STATED THAT COILING OF THE ANEURYSM HAS BEEN DIFFICULT AND THAT THE FIRST/FRAMING TARGET 3D 5×10 COIL (STRYKERNEUROVASCULAR) WAS UNABLE TO BE FIT. ONE TARGET 360 4.5×12 (STRYKERNEUROVASCULAR), TWO ULTRA 3×6 (UNKNOWN MANUFACTURER) AND FOUR NANO (2×4), (2×3), (2×3), (1.5× 3) (UNKNOWN MANUFACTURER) COILS HAVE BEEN USED. CONCOMITANT DEVICES USED COMPRISE A FUBUKI 8FR GUIDING CATHETER (ASAHI-INTECC), A DAC SOFIA 6FR CATHETER (MICROVENTION,) AND A PSP SL-10 MICROCATHETER (STRYKERNEUROVASCULAR). WITH THE ABOVE SYSTEM, THE PATIENT VITALS BECAME UNSTABLE DURING COILING. IT WAS FURTHER STATED THE FOLLOWING: ¿ICPC AN WAS TERMINATED DUE TO DETERIORATION OF THE PATIENT'S VITALS. AFTER HEMOSTASIS, CT WAS TAKEN TO CONFIRM INTRACEREBRAL HEMORRHAGE. THERE IS A POSSIBILITY OF INTRACEREBRAL HEMORRHAGE DUE TO ANEURYSM PERFORATION. IT IS UNKNOWN IF ANY ADDITIONAL TREA

  Patient problems: Aneurysm; Intracranial Hemorrhage

  MAUDE report 15885835 ↗
• InjuryNov 29, 2022Patient-Device Incompatibility; Patient-Device Incompatibility

  IT WAS REPORTED VIA POST MARKET STUDIES THAT ON (B)(6) 2022, A PATIENT UNDERWENT ENDOVASCULAR EMBOLIZATION OF AN UNRUPTURED ANEURYSM ON THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PULSERIDER T, 3MM, 8MM ARCH (CATALOG 201D/LOT 3053092710). COIL EMBOLIZATION WAS AFTER PERFORMED (UNKNOW NUMBER AND DEVICE DETAILS). IT WAS MENTIONED THAT ONE WING OF THE PULSERIDER WAS SUCCESSFULLY PLACED AT THE CEREBRAL ARTERY. COIL MASS WAS MAINTAINED, AND THE PROCEDURE COMPLETED. THERE WAS NO ABNORMALITY ON THE DEVICES. REPORTED ANEURYSM DIMENSIONS WERE: DIAMETER (HEIGHT) 9.5, ANEURYSM DIAMETER (LARGEST DIAMETER) 10.2MM, ANEURYSM DIAMETER (DOME WIDTH) 7.5MM, ANEURYSM NECK DIAMETER 5.2MM, DOME/NECK RATIO 1.4. PARENTAL VESSEL DIAMETER WAS 3.2MM. IT IS UNKNOWN IF CONTINUOUS FLUSH WAS DONE. DETAILS ON CONCOMITANT DEVICES ARE UNKNOWN. ON (B)(6) 2022 THE PATIENT EXPERIENCED AN ANEURYSM RECURRENCE DUE TO COIL COMPACTION WITHIN THE ANEURYSM. IT WAS MENTIONED ¿EMBOLIC COIL MIGRATION/EXTRUSION/ INSUFFICIENT EMBOLISM OCCURRED. THERE WAS NO PATIENT INJURY.

  Patient problems: Aneurysm

  MAUDE report 15876696 ↗
• InjuryNov 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED VIA POST MARKET STUDIES THAT ON (B)(6) 2022 A PATIENT UNDERWENT ENDOVASCULAR EMBOLIZATION OF AN UNRUPTURED ANEURYSM ON THE RIGHT MIDDLE CEREBRAL ARTERY (MCA) USING A PULSERIDER T, 3MM, 8MM ARCH (CATALOG 201D/LOT 3076329114). COIL EMBOLIZATION WAS PERFORMED AFTER (UNKNOWN NUMBER AND DEVICE DETAILS). IT WAS MENTIONED THAT THE PULSERIDER WAS SUCCESSFULLY IMPLANTED IN THE INTRACRANIAL ANEURYSM. COIL MASS WAS MAINTAINED, AND THE PROCEDURE COMPLETED. THERE WAS NO ABNORMALITY ON THE DEVICES. REPORTED ANEURYSM DIMENSIONS WERE: DIAMETER (HEIGHT) 5.6MM, ANEURYSM DIAMETER (MAXIMUM DIAMETER) 7.7MM, ANEURYSM DIAMETER (DOME WIDTH) 6.5MM, ANEURYSM NECK DIAMETER 7MM, DOME/NECK RATIO 0.9. PARENTAL VESSEL DIAMETER WAS 2.8MM. THE CONCOMITANT DEVICE USED WAS A PHENOM (MEDTRONIC) MICROCATHETER. IT IS UNKNOWN IF CONTINUOUS FLUSH WAS DONE. ON (B)(6) 2022 THE PATIENT EXPERIENCED A CEREBRAL INFARCTION ON THE REGION OF THE TARGET CEREBRAL ANEURYSM AND ALSO AT THE CONTRALATERAL SIDE. IT WAS MENTIONED THAT ¿A SELECTIVE THROMBOLYSIS PROCEDURE WAS PERFORMED. CONFIRMED RECOVERY OF OUTCOME¿. THE PHYSICIAN ASSESSED THE EVENT AS NON-SERIOUS AND IT WAS COMMUNICATED THAT ¿A CAUSAL RELATIONSHIP WITH TH

  Patient problems: Ischemia Stroke

  MAUDE report 15870542 ↗
• MalfunctionNov 7, 2022Failure to Advance; Failure to Advance

  LOG. THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING AN ANEURYSM ON THE DISTAL BASILAR ARTERY, THE COMPLAINT DEVICE, A PULSERIDER T SHAPE, 8MM , 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / 3075256523) WAS USED. A 7FR FUBUKI GUIDE CATHETER (ASAHI INTECC) WAS DELIVERED TO THE VERTEBRAL ARTERY. THE COMPLAINT MICROCATHETER, A 150CM X 5CM PROWLER SELECT PLUS MICROCATHETER (606S255X / 30734763) AND A GUIDEPOST® DISTAL ACCESS CATHETER (TOKAI MEDICAL) WERE USED WITH THE PULSERIDER ANRD. THE PROWLER SELECT PLUS MICROCATHETER WAS INSERTED INTO THE GUIDEPOST DISTAL ACCESS CATHETER OUTSIDE OF THE PATIENT¿S BODY AND THEN THE PROWLER SELECT PLUS MICROCATHETER WAS DELIVERED TO THE DISTAL BASILAR ARTERY. HOWEVER, IT WAS REPORTED THAT THE PULSERIDER ANRD GOT STUCK ON THE POINT FROM THE VERTEBRAL ARTERY TO THE BASILAR ARTERY. THE PHYSICIAN THOUGHT THAT THE GUIDEPOST DISTAL ACCESS CATHETER MIGHT HAVE AFFECTED THE PRESSURE, THEREFORE, THE GUIDEPOST WENT DOWN THE PROXIMAL SIDE. ANOTHER ATTEMPT WAS MADE BUT THE PULSERIDER ANRD GOT STUCK AT THE SAME POINT AGAIN. THE PHYSICIAN DID NOT PREPARE THE REBAR MICROCATHETER, THEREFORE, ANOTHER MICROCATHE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15745020 ↗
• InjurySep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A PULSERIDER-ASSISTED COIL EMBOLIZATION PROCEDURE WITH THE TARGET LESION LOCATED ON THE BASILAR ARTERY (BA), A PULSERIDER T SHAPE, 8MM , 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / 3074237320) WAS DEPLOYED AND AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER) WAS DELIVERED VIA TRANSCELL TECHNIQUE. THE COMPLAINT COIL, A 7MM X 21CM GALAXY G3 (GLY120721 / 30357882) WAS USED AS THE FIRST FRAMING COIL. IT WAS REPORTED THAT ¿THERE WAS NO PROBLEM FOR COIL EMBOLIZATION¿ HOWEVER, IT WAS ALSO REPORTED THAT WHEN THE COMPLAINT COIL WAS BEING RE-SHEATHED, THE SHEATH GOT DAMAGED AND THE RE-SHEATHING WAS ¿IMPOSSIBLE.¿ AN ANGIOGRAPHY WAS PERFORMED PRIOR TO DETACHMENT SHOWED THERE WAS BLEEDING. THE INTRACRANIAL HEMORRHAGE EVENT WAS CONSIDERED SERIOUS (MODERATE / MINIMAL) AS THE BLEEDING WAS CONTINUED FOR ABOUT 20 MINUTES. THE COMPLAINT DOCUMENTED THAT ¿SPAINDOLENAGE WAS TAKEN.¿ IT IS NOT KNOWN IF THE EVENT RESULTED IN PROLONGED HOSPITALIZATION. THE COMPLAINT THEN DOCUMENTED THAT ¿THE PROCEDURE WAS COMPLETED BY COIL EMBOLIZATION AND DETACHMENT OF THE PULSERIDER ANRD. THE PHYSICIAN COMMENTED THAT ¿THE RELATIONSHIP WITH THE DEVICES IS UNKN

  Patient problems: Intracranial Hemorrhage

  MAUDE report 15513977 ↗
• InjurySep 23, 2022Adverse Event Without Identified Device or Use Problem; Migration; Adverse Event Without Identified Device or Use Problem; Migration

  THE HEALTHCARE PROFESSIONAL REPORTED THAT THE 47-YEAR-OLD FEMALE PATIENT UNDERWENT A PULSERIDER-ASSISTED COIL EMBOLIZATION PROCEDURE TARGETING A 3.5MM BASILAR ARTERY (BA) ANEURYSM, A PULSERIDER T SHAPE, 8MM , 2.7 ¿ 3.5MM ANEURYSM NECK RECONSTRUCTION DEVICE (ANRD) (201D / LOT# UNKNOWN) WAS DEPLOYED VIA A PROWLER SELECT PLUS MICROCATHETER AND PLACED AT THE IDEAL POSITION ON THE FIRST ATTEMPT. AFTER THAT, AN EXCELSIOR® SL-10® MICROCATHETER (STRYKER) WAS DELIVERED TO THE LESION. THE MICROCATHETER WAS SET EXACTLY AT THE MIDDLE OF FOUR MARKERS ON THE PULSERIDER LEAFLET. TWO COIL EMBOLIZATION VIA THE TRANSCELL TECHNIQUE WERE PERFORMED WITHOUT ANY ISSUES. WHEN THE THIRD COIL, A 1.00MM X 2.00CM GALAXY G3 MINI (GLM910020 / LOT# UNKNOWN) WAS INSERTED, IT WAS REPORTED THAT THE COIL PENETRATED THE RIGHT UPPER PART OF THE ANEURYSM WHICH RESULTED IN BLEEDING. THIS THIRD COIL WAS DESCRIED AS ¿WOUND OUTSIDE THE ANEURYSM AS IT WAS, AND THE COIL WAS LEFT FOR A WHILE.¿ ANGIOGRAPHY WAS TAKEN AGAIN AFTER A WHILE AND IT WAS CONFIRMED THAT THE BLEEDING HAD STOPPED. AFTER THAT, IT WAS REPORTED THAT THE PULSERIDER WAS PROMPTLY DETACHED AND THE PROWLER SELECT PLUS MICROCATHETER WAS REMOVED. THE COIL WAS DETA

  Patient problems: Aneurysm; Intracranial Hemorrhage

  MAUDE report 15473910 ↗