DELTAXSFT DLX100306Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10886704077350), received between Jul 12, 2017 and May 28, 2026 — classified as 5 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (6 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 16, 2026.

Most reported problems

Recent adverse event reports

The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Separation Failure

  A HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION, A DELTAXSFT10 3MM X 6CM COIL (PRODUCT CODE: DLX100306, LOT NUMBER: 2022554S) COULD NOT BE DEPLOYED. EVEN WITH A SECOND RELEASE DEVICE. THERE WAS NO PATIENT HARM. THERE WAS NO SIGNIFICANT DELAY. ADDITIONAL EVENT INFORMATION RECEIVED ON 22-MAY-2026 CONFIRMED THAT THE COIL JUST COULDN¿T DETACH UPON SYSTEM ACTIVATION. THE COIL WAS IN THE RIGHT POSITION. THERE WAS NO COIL HERNIATION. THE COIL DID NOT PROTRUDE INTO THE PARENT VESSEL. THE PROCEDURE WAS COMPLETED. THERE WAS NO ALLEGATION OF PATIENT INJURY DUE TO AN ALLEGED PRODUCT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25317413 ↗
• InjuryNov 18, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT TWO DELTAXSFT10 3MM X 6CM (DLX100306/ 31188524) MICRO-COILS WERE USED FOR AN ENDOVASCULAR EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE USER REPORTED COIL IMPEDIMENT IN THE MICROCATHETER FOR BOTH COILS. THE EVENTS RESULTED IN A 25-MINUTE PROCEDURAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿CUSTOMER HAS ANOTHER COMPLAINT, AGAIN COILS GOT STUCK IN THE CATHETER (SL-10) OR COULD NOT BE INSERTED. BEFORE THE COIL GOT STUCK, THE PREVIOUS COILS COULD EASILY BE PUSHED THROUGH THE SAME CATHETER. COIL AND CATHETER WILL BE SENT IN FOR EXAMINATION.¿ ON 07-NOV-2024, ADDITIONAL INFORMATION WAS RECEIVED. SUMMARY: PER THE INFORMATION, THE PATIENT IS A 66-YEAR-OLD CAUCASIAN FEMALE WITH A MEDICAL HISTORY OF DEPRESSION AND MIGRAINE. THE TARGET VESSEL WAS THE MIDDLE CEREBRAL ARTERY (MCA) BIFURCATION THE INFORMATION INDICATED THAT ¿MICROCATHETERS WERE CONTINUOUSLY FLUSHED WITH HEPARINIZED SALINE AT FULL SPEED ALL THE TIME.¿ THE SL-10 MICROCATHETER WAS REMOVED AND REPLACED BY AN ECHELON-10 MICROCATHETER. RELEVANT ANATOMICAL INFORMATION WAS NOTED AS ¿NO RELEVANT TORTUOSITY, MCA 2.5MM, NO CALCIFICATIO

  Patient problems: Thromboembolism

  MAUDE report 20708319 ↗
• MalfunctionDec 21, 2023Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING COIL EMBOLIZATION TO THE RIGHT RIGHT ANTERIOR COMMUNICATING ARTERY, , A DELTAXSFT10 3MM X 6CM COIL (DLX100306, 30498375) WAS ADVANCED INTO THE MICROCATHETER AND STOPPED BEFORE REACHING DETACHMENT ZONE. THE MICROCATHETER (MC) WAS AN ECHELON 10. ADDITIONAL COILS WERE PLACED WITH NO ISSUES. NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE RESISTANCE HAPPENED IN THE DISTAL PART OF THE MICROCATHETER. A DELTAFILL COIL WAS USED PRIOR TO THE RESISTANCE AND SEVERAL STRYKER COILS AFTER. THE MC WAS NOT REMOVED, AND THEY CONTINUE USING IT. THERE WERE NO NOTED ANATOMY DIFFICULTIES. NO, DAMAGE VISIBLE ON THE DEVICE. THERE WAS NOTHING NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. THE TIP OF THE INTRODUCER WAS FIRMLY INSTALLED INTO THE HUB OF THE MICROCATHETER AND LOCKED WITH THE RHV DURING DEVICE ADVANCEMENT. BASED ON THE PRODUCT ANALYSIS, THE EMBOLIC COIL WAS FOUND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18373943 ↗
• MalfunctionSep 27, 2023Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A DELTAXSFT10 3MM X 6CM COIL (DLX100306, 30921363) DID NOT DETACH. OTHER COILS WERE USED BEFORE AND AFTER WITHOUT ANY PROBLEM. THERE WERE NO PROCEDURAL DELAYS DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17825445 ↗
• MalfunctionMay 25, 2022Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION OF THE CAROTID ARTERY, A 3MM X 6CM DELTAXSFT10 COIL (DLX100306, 30481268) WAS ATTEMPTED TO BE PLACED AND WOULD ONLY ADVANCE HALFWAY INTO THE ECHELON 10 MICROCATHETER (MC). IT WAS NOT NECESSARY TO REMOVE OR REPLACE THE MC. NEITHER THE COIL OR THE MC APPEARED TO BE DAMAGED. NOTHING WAS OBSTRUCTING THE MICROCATHETER. THE PROCEDURE WAS COMPLETED BY USING A COMPETITOR¿S COIL. THERE WAS NO PATIENT INJURY REPORTED. BASED ON THE DEVICE ANALYSIS OF THE PRODUCT RECEIVED, THE EMBOLIC COIL WAS FOUND SLIGHTLY STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14498213 ↗
• MalfunctionAug 18, 2021Failure to Advance; Failure to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 3MM X 6CM DELTAXSFT10 COIL (DLX100306, L16594) WAS NOT ADVANCED THROUGH THE SL10 EXCELSIOR, STRYKER MICROCATHETER (MC). THE PHYSICIAN FELT STRONG RESISTANCE AND STOPPED ADVANCING THIS COIL. THE RESISTANCE WAS FIRST FELT AT THE MIDDLE PART OF THE MC. THE COIL SYSTEM WAS FULLY REMOVED FROM THE MC. THERE WAS NO CEREBRAL TARGET LOSS. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. OTHER DEVICES WERE SUCCESSFULLY USED WITH THE SAME MICROCATHETER PRIOR TO/AFTER THE ENCOUNTERED RESISTANCE. THE MICROCATHETER WAS NOT DAMAGED DURING MANIPULATION OF THE DEVICE OR NOTICED TO BE DAMAGED UPON REMOVAL FROM THE PATIENT. THERE WAS NO APPARENT DAMAGE TO THE COIL DELIVERY SYSTEM AT ANY TIME. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. A CONTINUOUS FLUSH ON THE MICROCATHETER WAS MAINTAINED. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. NO ADDITIONAL INFORMATION IS AVAILABLE. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL IS DAMAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12337725 ↗
• MalfunctionJun 14, 2021Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ANEURYSM COILING PROCEDURE WITH THE TARGET LOCATED ON THE MIDDLE CEREBRAL ARTERY (MCA), THE 3MM X 6CM DELTAXSFT 10 COIL (DLX100306 / L16538) COULD NOT BE DETACHED EVEN AFTER THE DETACHMENT BUTTON WAS PRESSED SEVERAL TIMES TO INITIATE THE DETACHMENT CYCLE. THE PHYSICIAN REMOVED THE COIL THROUGH THE EXCELSIOR® SL-10® MICROCATHETER (STRYKER). THE COIL WAS NOT STRETCHED WHEN IT WAS REMOVED; IT WAS NOT BROKEN NOR DETACHED DURING RETRIEVAL. IT WAS REPORTED THAT A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE FAULT LIGHT WAS NOT SEEN DURING THE CASE. WHEN THE POWER BUTTON WAS PRESSED ON THE ENPOWER CONNECTING CABLE, ALL THE LIGHTS ILLUMINATED AND THE AUDIBLE SIGNAL BEEP WAS HEARD. ALL CONNECTIONS APPEARED TO FIT PROPERLY WITHOUT THE APPLICATION OF EXCESSIVE FORCE. A NEW COIL WAS USED AS REPLACEMENT AND THE SAME CONCOMITANT MICROCATHETER AND THE SAME ENPOWER CONTROL CABLE WAS USED TO COMPLETE THE PROCEDURE. IT WAS REPORTED THAT THERE WAS NO DELAY IN THE PROCEDURE AS A RESULT OF THE REPORTED EVENT; THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11992677 ↗
• MalfunctionAug 18, 2020Positioning Problem; Positioning Problem

  AS REPORTED BY THE FILED, DURING A COIL EMBOLIZATION, THE PHYSICIAN DIDN'T LIKE THE SHAPE OF THE COIL DEPLOYMENT OF A 3MM X 6CM (DLX100306, L15976) AND DECIDED TO PULL IT OUT. DURING RESHEATHING OF THE COIL, THE INTRODUCER FAILED TO BE RE-ZIPPED. THE PHYSICIAN USED A SAME LIKE PRODUCT. THE PROCEDURE WAS SUCCESSFULLY FINISHED. THERE WAS NOT PATIENT INJURY REPORTED. THIS COIL WAS BEING USED FOR FRAMING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10420345 ↗
• InjuryJul 14, 2020Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  A REPORT FROM THE FIELD INDICATED THAT AFTER DETACHING THE 3MM X 6CM DELTAXSFT10 (DLX100306/L16594) COIL AND RETRACTING THE DELIVERY WIRE, THE PHYSICIAN NOTICED THAT THE PROXIMAL SEGMENT OF THE MICROCOIL WAS STILL INSIDE THE SL-10 (STRYKER) MICROCATHETER. THE PHYSICIAN TRIED TO PUSH THE COIL OUT OF THE DISTAL END OF THE MICROCATHETER USING A MICROWIRE, BUT IT SEEMED TO BE STUCK IN THE MICROCATHETER. THE MICROWIRE WAS CHANGED AND THE PHYSICIAN PUSHED HARD SINCE SMALLER FORCE DID NOT MAKE THE COIL MOVE. FINALLY, THE PHYSICIAN RELEASED THE COIL FROM THE MICROCATHETER, BUT IN DOING SO, THE LATERAL WALL OF THE ANEURYSM RUPTURED. THE PROCEDURE WAS COMPLETED WITH COMPETITOR COILS AND THE SAME MICROCATHETER. PER THE TREATING PHYSICIAN, THE PATIENT WAS STABLE FOLLOWING THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED AT THE TIME OF COMPLAINT INITIATION.

  Patient problems: Rupture

  MAUDE report 10270364 ↗
• InjuryAug 7, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, THE COIL OF A 3MM X 6CM DELTAXSFT10 (DLX100306, L15976) COIL DELIVERY SYSTEM CAME ¿BACK WITH THE PUSHER DESPITE A SIGNAL OF DETACHMENT¿. THE COIL WAS PUSHED BACK INSIDE THE ANEURYSM WITH THE PUSHER. THERE WAS NO PATIENT INJURY REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Code Available

  MAUDE report 8871695 ↗
• MalfunctionAug 5, 2019Migration or Expulsion of Device; Migration or Expulsion of Device

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION, WHEN THE PHYSICIAN PULLED BACK THE PUSHER AFTER 50 CM, A 3MM X 6CM DELTAXSFT10 (DLX100306, L15976) COIL CAME BACK. THERE WAS NO PATIENT CONSEQUENCES. THERE WAS NO SURGERY DELAYED DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8862083 ↗
• InjuryJul 9, 2019Positioning Problem; Migration; Material Too Soft/Flexible; Positioning Problem; Migration; Material Too Soft/Flexible

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION OF AN ANTERIOR CEREBRAL ARTERY ANEURYSM IN THE (B)(6) FEMALE PATIENT WITH A HISTORY OF HYPERTENSION WHO INITIALLY PRESENTED WITH A 3/4MM 2MM NECK ANTERIOR COMMUNICATING ARTERY (ACOM) ANEURYSM THAT WAS SACCULAR IN SHAPE, A 3MM X 6CM DELTAXSFT 10 COIL (DLX100306 / L11461) WAS ADVANCED INTO THE ANEURYSM AND DETACHED. BEFORE THE SECOND COIL COULD BE ADVANCED, THE 3MM X 6CM DELTAXSFT 10 COIL LOST ITS SHAPE, THE BASKET WHICH WAS INITIALLY FORMED CHANGED CONFIGURATION AFTER DETACHMENT AND PROTRUDED FROM THE ANEURYSM BLOCKING THE PROXIMAL A1 SEGMENT. IT WAS REPORTED THAT THERE WAS DIFFICULTY IN THE INITIAL POSITIONING OF THE COIL IN THE TARGET ANEURYSM AND THERE WAS CONFORMABILITY ISSUE AS THE COIL WAS REPORTED TO HAVE LOST ITS SHAPE. THE COIL DID NOT BECOME STRETCHED. THE ANEURYSM WAS SECURED USING TARGET® NANO¿ SOFT COILS (STRYKER), BUT THE A1 SEGMENT REMAINED BLOCKED AND THE PATIENT SUBSEQUENTLY SUFFERED A STROKE. THERE IS NO FOLLOW-UP PROCEDURE PLANNED TO ADDRESS THE PORTION OF THE DELTA COIL THAT CAME OUT OF THE ANEURYSM. MAGNETIC RESONANCE IMAGING (MRI) SHOWED ANTERIOR CEREBRAL ARTERY (ACA) INFARCT, AND THERE WAS

  Patient problems: Infarction, Cerebral; No Code Available; Obstruction/Occlusion

  MAUDE report 8773895 ↗
• MalfunctionJun 12, 2019Separation Failure; Separation Failure

  AS REPORTED BY AN AFFILIATE, WHEN USING A MFR140512 COIL (MFR140512, L14136) AS THE FIRST COIL AND A DELTAXSFT10 (DLX100306, L14759) AS A THIRD COIL, DETACH FAILURE WAS ENCOUNTERED WHILE DETACHING BOTH COILS. WHEN THE PHYSICIAN TRIED TO DETACH THE COIL WITH AN ENPOWER CONTROL CABLE (ECB00018200, L14798), THE BEEPING SOUND WAS NORMAL (CONNECTION LIGHT WAS ALSO OK). BUT DURING RETRIEVING DELIVERY SYSTEM, IT CONTINUOUSLY CAME OUT ALONG THE DELIVERY SYSTEM. THE ENPOWER DETACHABLE CONTROL BOX (DCB2000500, L12008) AND THE CONNECTING CABLE WERE CHANGED TO NEW ONES. BUT THE CHANGED ONES ALSO SHOWED DETACH FAILURES. BOTH COILS WERE BARELY DETACHED AFTER 5~7 TIMES OF DETACH TRIALS. THE SURGERY WAS DELAYED DUE TO THE REPORTED EVENT BY 20~25 MINUTES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE TWO ENPOWER DETACHABLE CONTROL BOXES AND ONE CONTROL CABLE IS AVAILABLE FOR ANALYSIS. ONE CONTROL CABLE WAS DISCARDED AT THE HOSPITAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8692492 ↗
• MalfunctionNov 2, 2018Off-Label Use; Separation Failure; Material Twisted/Bent; Off-Label Use; Separation Failure; Material Twisted/Bent

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A COIL EMBOLIZATION OF A BRONCHIAL-INTERCOSTAL ARTERY, THE FIFTH SPECTRA COIL FAILED TO DETACH IN THE TARGET LESION. SEVERAL ATTEMPTS WERE MADE TO DETACH THE COIL WITHOUT SUCCESS; THEREFORE, THE ENPOWER CONTROL CABLE (ECB000182-00/S14572) WAS REPLACED AND THE COIL WAS DETACHED SUCCESSFULLY. THE 3MM X 12CM DELTAFILL18 (DLF180312/S14732) THERMO-MECHANICAL COIL WAS THEN CONNECTED TO THE CONTROL CABLE, BUT THE POWER LAMP DID NOT ILLUMINATE. THE COIL WAS REPLACED. TWO ADDITIONAL SPECTRA COILS WERE PLACED. THE 3MM X 6CM DELTAXTRASOFT (DLX100306/S14197) THERMO-MECHANICAL COIL WAS THEN INSERTED INTO THE PATIENT, BUT THE COIL FAILED TO BE DETACHED DESPITE MULTIPLE ATTEMPTS. THE POWER LAMP WAS ON AND THE CONTROL CABLE WAS NEW. THE COIL WAS REPLACED WITH A SAME-SIZED COIL AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. THERE WAS NO REPORT OF PATIENT INJURY. THE SURGERY WAS NOT DELAYED DUE TO THE EVENT. THE PRODUCTS WERE NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND AN ADEQUATE CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THE COIL D

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8033464 ↗
• MalfunctionAug 6, 2018Material Twisted/Bent; Material Twisted/Bent

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PRE-PANCREATIC CANCER REMOVAL COIL EMBOLIZATION PROCEDURE WITH THE TARGET LESION AT THE RIGHT GASTRIC ARTERY, THE MICROCATHETER AND GUIDEWIRE APPROACHED THE TARGET LESION WITH VESSEL DIAMETER MEASURED AT 2.5 MM, AS A UNIT AND THE COIL EMBOLIZATION WAS STARTED WITH THE DELTAXSFT 10 3 MM X 6 CM (DLX100306 / S12431) WAS CHOSEN AS THE FIRST COIL FOR THE PROCEDURE, BUT THE DELTA XTRASFT COIL COULD NOT BE PLACED PROPERLY BECAUSE THE FLOW IN THE VESSEL WAS TOO STRONG; THE PHYSICIAN TRIED TO RESHEATH THE COIL BUT IT COULD NOT BE RESHEATHED. THE DELTA XTRASFT COIL WAS REPLACED WITH THE DELTAFILL 18 4 MM X 15 CM (DLF180415 / S14146). THE PHYSICIAN COULD NOT USE THIS DELTAFILL COIL BECAUSE IT WAS OVERSIZED FOR THE LESION. IT WAS REPLACED WITH THE DELTAFILL 18 3 MM X 12 CM COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7752508 ↗
• MalfunctionJul 30, 2018Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ANEURYSM TREATMENT, THE PHYSICIAN WANTED TO PLACE 6 COILS INTO THE ANEURYSM. THE 5TH COIL, A DELTAXSFT 10 3MM X 6CM COIL (DLX100306 / L10256) DID NOT COMPLETELY DETACH. THE PHYSICIAN MANAGED TO PROPERLY PLACE THE COIL AND WAS ABLE TO DETACH IT BY MOVING IT BACK AND FORTH. THERE WAS NO REPORT OF ANY PATIENT INJURY OR ADVERSE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7733228 ↗
• MalfunctionJun 12, 2018Kinked; Stretched; Kinked; Stretched

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE COIL EMBOLIZATION PROCEDURE, THE DELTAXSFT10 3 MM X 6 CM (DLX100306 / S12021) DID NOT COME OUT FROM THE COIL INTRODUCER. AFTER FLUSHING THE COIL, THE ORIGINAL GREEN PART OF THE STOPPER CHANGED COLOR AND BECAME CLOSE TO A GRAY COLOR. THE PRESCORE AREA OF THE COIL INTRODUCER WAS NOT OPEN TO EXPOSE THE COIL / DEVICE POSITION UNIT (DPU). THE COIL / DPU DID NOT PROTRUDE FROM THE COIL INTRODUCER. THE COIL WAS REPLACED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO REPORT OF PATIENT INJURY OR COMPLICATION; THE COMPLAINT PRODUCT WAS NEW AND WAS STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTION FOR USE (IFU) WITH CONSTANT FLUSH MAINTAINED AT ALL TIME. THERE WAS NO VISIBLE DEFECT OR DAMAGE NOTED ON THE PRODUCT PRIOR TO THE EVENT. THERE WAS NO UNINTENDED DETACHMENT OBSERVED IN THE VESSEL OR IN THE MICROCATHETER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7593687 ↗
• MalfunctionJan 3, 2018Positioning Failure; Premature Activation; Positioning Failure; Premature Activation

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT DURING A COIL EMBOLIZATION OF AN UNRUPTURED MIDDLE CEREBRAL ARTERY M1 SEGMENT ANEURYSM, A 3 MM X 6 CM DELTAXSFT10 (DLX100306/S13450) THERMO-MECHANICAL COIL WAS INSERTED INTO THE LESION AS THE LAST COIL; HOWEVER, THE COIL COULD NOT BE DETACHED. THE DETACHMENT BUTTON WAS PRESSED AND THE POWER LIGHT WAS ILLUMINATED. THE PHYSICIAN ATTEMPTED TO DETACH THE COIL FIVE TIMES BUT THE ISSUE CONTINUED. THE COIL WAS SUBSEQUENTLY REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE ISSUE RESULTED IN A FIVE-MINUTE PROCEDURAL DELAY. THERE WAS NO REPORT OF PATIENT INJURY. THE PATIENT¿S VESSEL WAS NEITHER TORTUOUS NOR CALCIFIED. A SL10 (STRYKER) MICROCATHETER AND DCB02 WERE ALSO USED FOR THE CASE. THE PRODUCT WAS STERILE AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND A CONSTANT FLUSH WAS MAINTAINED. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCT PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PRODUCT WILL BE RETURNED FOR ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7159968 ↗
• MalfunctionOct 26, 2017Premature Activation; Stretched; Premature Activation; Stretched

  AS REPORTED VIA A HEALTH PROFESSIONAL, A DELTAXSFT (DLX100306/ S14198) PREMATURELY DETACHED WHILE BEING POSITIONED IN THE 5.5MM CAROTID TERMINUS ANEURYSM. AN ENTERPRISE2 4MM X 30MM STENT HAVE BEEN PLACED SUCCESSFULLY AND THE PHYSICIAN HAD JAILED THE SL10 COILING CATHETER IN PLACE. THE ANEURYSM SUCCESSFULLY FRAMED WITH A MICRUSFRAME 5MM X 9.7CM MICROCOIL. THIS WAS FOLLOWED BY A GALAXY G3 4MM X 8CM COIL AND THEN AN ADDITIONAL GALAXY 4MM X 6CM COIL. THE DELTAXSFT 3MM X 6CM COIL (COMPLAINT COIL) WAS CHOSEN FOR THE NEXT COIL, BUT IT UNINTENTIONALLY DETACHED DURING PLACEMENT INTO THE ANEURYSM. APPROXIMATELY 2/3 OF THE COIL WAS PLACED IN THE ANEURYSM WHEN THE PHYSICIAN BEGAN TO REPOSITION THE COIL. AFTER A SMALL AMOUNT OF MOVEMENT PULLING THE COIL OUT AND ADVANCING IT, THE PHYSICIAN DECIDED HE DID NOT HAVE CONTROL OF THE COIL AND FELT IT HAD DETACHED. THE PHYSICIAN CONFIRMED HE COULD NOT REMOVE THE COIL. THE COIL DETACHED IN THE MICROCATHETER WITHOUT ACTIVATING THE ENPOWER CABLE. IT APPEARED TO DETACH WITH MINIMAL MANIPULATION BY THE PHYSICIAN. HE THEN SUCCESSFULLY PUSHED THE REMAINING APPROX. 1.5CM OF COIL INTO THE ANEURYSM, BUT IT WAS IN A POSITION THAT WAS NOT COMPLETELY SECURED WITH T

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6978953 ↗
• MalfunctionOct 20, 2017Physical Resistance; Physical Resistance

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COIL EMBOLIZATION OF AN INTERNAL CAROTID ARTERY ¿ PARACLINOID ARTERY, A DELTAXTRASOFT (DLX100306/ C40394R) WAS STUCK IN THE HEADWAY 17 MICROCATHETER DURING WITHDRAWAL OF THE COIL DELIVERY SYSTEM. AFTER IMPLANTING SEVERAL MICROCOILS IN THE ANEURYSM, THE COMPLAINT DELTAXTRASOFT WAS INSERTED AND THEY SUCCESSFULLY DETACHED THE COIL. WHEN ITS DELIVERY WIRE WAS BEING REMOVED, THERE WAS STRONG RESISTANCE FELT. THEN BOTH THE DELIVERY WIRE AND THE MICROCATHETER WERE REMOVED FROM THE PATIENT. A NEW MICROCATHETER WAS INSERTED TO PROCEED WITH THE PROCEDURE, BUT IT COULD NOT BE DELIVERED TO THE TARGET LESION AND THE PHYSICIAN DECIDED NOT TO PLACE ANOTHER COIL. AFTER THE PROCEDURE, THE SALES REP TOUCHED THE REMOVED COMPLAINT DELIVERY WIRE WITH THE MICROCATHETER AND COMMENTED THAT THEY WERE STUCK HARD. IT WAS REPORTED THAT THE DEVICE APPEARED NORMAL PRIOR TO USE AND THERE HAD BEEN NO DIFFICULTY DURING ADVANCEMENT OF THE DEVICE THROUGH THE MICROCATHETER OR DETACHMENT OF THE COIL. BOTH DEVICES WERE USED AS PER THE INSTRUCTIONS FOR USE (IFU). THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES. THERE WAS ALSO NO PATIENT INJURY / COMPLICATI

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6964146 ↗
• InjuryJul 12, 2017Difficult To Position; Difficult To Position

  IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT, DURING A DISTAL ANTERIOR CEREBRAL ARTERY COILING PROCEDURE, A MICRUS FRAME S 5X10 COIL (MFR100509/S11178) KICKED UP A NUMBER OF TIMES AND THE PROWLER 14 MICROCATHETER (UNKNOWN PRODUCT CODE/LOT) JUMPED OUT OF THE ANEURYSM 6 TO 7 TIMES WITH A DELTAXSFT 10 COIL (DLX100306/S11751); THEREFORE, THE PHYSICIAN DECIDED TO REMOVE THIS COIL FROM THE SYSTEM. A MICRUS FRAME S 5 X 10 COIL WAS USED WITH THE SAME MICROCATHETER PRIOR TO THE DELTAXSFT 10 COIL (COMPLAINT PRODUCT 1) AND THE PROWLER 14 MICROCATHETER (COMPLAINT PRODUCT 3) KICKED UP A NUMBER OF TIMES. HOWEVER, THE PHYSICIAN WAS ABLE TO DEPLOY THE MICRUS FRAME S 5 X 10 COIL (COMPLAINT PRODUCT 2) AFTER 3 ATTEMPTS. THE PROWLER 14 MICROCATHETER WAS NOT REMOVED FROM THE PATIENT AND THE PHYSICIAN COMPLETED THE PROCEDURE WITH BLOCKADE COILS. THE PROCEDURE WAS DELAYED 30 MINUTES. ON (B)(6) 2017, THE PATIENT EXPERIENCED A MILD STROKE POST PROCEDURE. IT IS UNKNOWN HOW THE STROKE WAS TREATED. REPORTEDLY, THE PATIENT HAS MADE A COMPLETE RECOVERY AND IS BEING DISCHARGED TO THEIR HOME NEURO INTACT. THE PATIENT'S INFORMATION IS UNKNOWN; HOWEVER, THE TARGET VESSEL WAS REPORTED TO BE DISTAL A2 WITH SMALL

  Patient problems: No Code Available

  MAUDE report 6706392 ↗