DELTAFILL DLF180733Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10886704076940), received between Apr 27, 2017 and Sep 4, 2025 — classified as 1 injury, 14 malfunctions.

The most frequently reported specific device problem is “Separation Failure” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2025Positioning Problem; Premature Separation; Positioning Problem; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION OF THE INTERNAL ILIAC ARTERY PRIOR TO AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) TO TREAT AN ABDOMINAL AORTIC ANEURYSM, DEVICES WERE USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFUS). AFTER APPROACHING THE RIGHT INTERNAL ILIAC ARTERY FROM THE CONTRALATERAL SIDE, USING 6FR DESTINATION® GUIDING SHEATH (TERUMO INTERVENTIONAL), A 5FR DIAGNOSTIC CATHETER (UNSPECIFIED BRAND), AND A BREAKTHROUGH¿ MICROCATHETER (BOSTON SCIENTIFIC), THE EMBOLIZATION OF THE INFERIOR GLUTEAL ARTERY WAS INITIATED. THE INFERIOR GLUTEAL ARTERY WAS EMBOLIZED USING AN EMBOLD¿ DETACHABLE COIL SYSTEM (BOSTON SCIENTIFIC) AND A 7MM X 33CM DELTAFILL 18 (DLF180733) AND WAS COMPLETED WITHOUT ANY ISSUE. THEN THE SUPERIOR GLUTEAL ARTERY EMBOLIZATION WAS INITIATED. A 6MM EMBOLD COIL WAS PLACED AS THE FIRST COIL. A 9MM X 35CM DELTAFILL 18 (DLF180935 / 1182524S) WAS USED AS THE SECOND COIL. DURING COIL INSERTION, THE BREAKTHROUGH MICROCATHETER DISLODGED FROM THE SUPERIOR GLUTEAL ARTERY. DURING THE COIL RETRIEVAL, THE SHEATH TORE, AND RE-SHEATHING WAS NOT POSSIBLE. THE 9MM X 35CM DELTAFILL 18 (DLF180935) WAS REPLACED WITH ANOTHER 9MM X 35CM DELTAFILL 18 (DL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22965494 ↗
• MalfunctionDec 13, 2023Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, THIS WAS A A COIL EMBOLIZATION OF THE RIGHT INTERNAL ILIAC ARTERY PRIOR TO EVAR, USING 5FR DIAGNOSTIC CATHETER AND COILING SUPPORT. THE ABOVE SYSTEM WAS ADVANCED TO THE LESION. AFTER IMPLANTED 2 OF THE J&J COILS, A DELTAFILL18 7MM X 33CM COIL (DLF180733, 30768264) WAS USED AS A THIRD COIL. ATTEMPTED TO DETACH BUT COULD NOT. ATTEMPTED AGAIN BUT COULD NOT DETACH THE COIL. THE SAME CABLE WAS USED FIRST TO THIRD COIL. THE CABLE WAS REPLACED WITH ANOTHER NEW ONE, BUT THE ISSUE WAS NOT RESOLVED. REPLACED THE COIL (DLF180733) WITH ANOTHER NEW ONE, WHICH DID DETACH. THE PROCEDURE WAS COMPLETED WITH TOTAL 5 COILS IMPLANTED. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT. A CONTINUOUS FLUSH WAS DONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18322282 ↗
• MalfunctionMay 15, 2023Device Difficult to Setup or Prepare; Positioning Problem; Device Difficult to Setup or Prepare; Positioning Problem

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION PROCEDURE TARGETING A PULMONARY ARTERIOVENOUS MALFORMATION (AVM), COIL EMBOLIZATION WAS INITIATED FROM THE DRAINER SIDE BEYOND THE SHUNT FROM THE FEEDER. A MICROCATHETER (UNSPECIFIED BRAND) APPROACHED AND COIL EMBOLIZATION WAS STARTED. THE COMPLAINT COIL, A 7MM X 33CM DELTAFILL 18 (DLF180733 / 30778017) WAS USED AS THE FIFTH COIL, BUT RESHEATHING WAS ¿IMPOSSIBLE.¿ THE ENTIRE SYSTEM WAS REMOVED. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER SMALLER SIZED COIL AND THE PROCEDURE WAS COMPLETED WITH THE IMPLANTATION OF FIFTEEN (15) COILS. A CONTINUOUS FLUSH WAS MAINTAINED THROUGH THE MICROCATHETER. THERE WAS NO REPORT OF ANY NEGATIVE PATIENT IMPACT. ON 07-MAY-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE INFORMATION INDICATED THAT THERE WAS NO DAMAGE NOTED ON THE INTRODUCER SHEATH. THERE WAS NO RESISTANCE REPORTED AT ANY TIME DURING THE ADVANCEMENT OF THE COMPLAINT COIL THROUGH THE MICROCATHETER. NECK MODELING WAS NOT USED. THE COMPLAINT COIL WAS NOT POSITIONED AT A RELATIVELY SHARP ANGLE TO THE MICROCATHETER. THE MICROCATHETER WAS NOT REMOVED FROM THE TARGET. ON 14-MAY-2023, ADDITIONAL INFORMATION WAS RECEIVED. THE IN

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16935249 ↗
• MalfunctionFeb 22, 2023Difficult to Advance; Difficult to Advance

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR A COMMON ILIAC ARTERY ANEURYSM, AN ANGIOGRAPHY CATHETER WAS INSERTED AND DELIVERED TO THE LESION AND TWO AZUR35 SYSTEMS WERE USED AS ANCHORING. A MICROCATHETER (COILING SUPPORT) APPROACHED TO THE COIL MASS. A DELTAFILL18 7MM X 33CM COIL (DLF180733, 30633415) WAS USED AS THE THIRD COIL BUT THERE WAS RESISTANCE FELT BETWEEN THE COMPLAINT COIL AND THE MICROCATHETER. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL (SAME CATALOG NUMBER) AND THE PROCEDURE COMPLETED. THERE WAS NO NEGATIVE IMPACT ON THE PATIENT. A CONTINUOUS FLUSH WAS DONE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT IT WAS NOT NECESSARY TO REMOVE OR REPLACE THE MICROCATHETER. NO DAMAGE WAS NOTED ON THE DEVICE. THE DEVICE WAS ABLE TO MOVE. NOTHING WAS NOTED TO BE OBSTRUCTING THE MICROCATHETER. NO EXCESSIVE FORCE WAS APPLIED TO THE DEVICE. BASED ON THE ANALYSIS OF THE DEVICE RECEIVED, THE EMBOLIC COIL IS SEVERELY STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16418852 ↗
• MalfunctionNov 2, 2022Separation Failure; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION FOR AN ANTERIOR CELIAC ARTERY OF THORACIC, THE FIRST UNSPECIFIED COIL WAS DETACHED WITHOUT ANY PROBLEMS. A DELTAFILL18 7MM X 33CM COIL (DLF180733, 30768263) WAS USED AS THE SECOND COIL BUT THE COMPLAINT COIL WAS UNABLE TO BE DETACHED. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE COMPLETED. THE PATIENT HAS BEEN STABLE. A CONTINUOUS FLUSH WAS NOT DONE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15715226 ↗
• MalfunctionMay 4, 2022Premature Separation; Premature Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) COIL EMBOLIZATION PROCEDURE WITH THE TARGET AT THE INTERNAL ILIAC ARTERY (IIA), AN ANGIO CATHETER WAS ACCESS VIA THE MICROCATHETER AND COILING WAS INITIATED. DURING THE PROCEDURE, A TOTAL OF 21 CERENOVUS COILS WERE USED. THE COMPLAINT COIL, A 7MM X 33CM DELTAFILL 18 (DLF180733 / 30656473) WAS ADVANCED INSIDE THE RENEGADE¿ MICROCATHETER (BOSTON SCIENTIFIC) AS PER THE INSTRUCTIONS FOR USE (IFU). HOWEVER, THE COMPLAINT PRODUCT BECAME PREMATURELY DETACHED IN THE MICROCATHETER (BEFORE THE COIL EXITED THE MICROCATHETER AND ENTER THE PATIENT¿S BODY). BECAUSE THE COMPLAINT COIL WAS STILL INSIDE THE MICROCATHETER, THE MICROCATHETER AND THE COMPLAINT COIL WERE REMOVED FROM THE PATIENT. CONTINUOUS FLUSH WAS NOT MAINTAINED. IT WAS REPORTED THAT FACTORS THAT MAY HAVE CAUSED THE PREMATURE DETACHMENT ARE NOT KNOWN. THE PROCEDURE WAS REPORTED TO BE SUCCESSFULLY COMPLETED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT AS THE COMPLAINT COIL WAS STILL INSIDE THE MICROCATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14274801 ↗
• MalfunctionJul 1, 2021Separation Failure; Malposition of Device; Separation Failure; Malposition of Device

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A COIL EMBOLIZATION OF A PULMONARY ARTERIOVENOUS MALFORMATION (AVM), THE 7MM X 33CM DELTAFILL 18 COIL (DLF180733 / L16350) WAS USED AS A FILLING COIL. THE COMPLAINT DOCUMENTED THAT IT WAS NOT CLEAR IF A PRE-DEPLOYMENT ELECTRICAL CHECK WAS PERFORMED. THE COMPLAINT COIL WAS INSERTED AND CONNECTED TO THE CONNECTOR AT THE DETACHMENT POINT. HOWEVER, THE LIGHT WAS NOT ILLUMINATED. THE PHYSICIAN RECONNECTED SEVERAL TIMES AND THE LIGHT ILLUMINATED. THE PHYSICIAN PRESSED THE DETACHMENT BUTTON AND THE AUDIBLE BEEP SIGNAL WAS HEARD, BUT THE COIL WAS NOT ABLE TO BE DETACHED. THE PHYSICIAN MADE SEVERAL MORE ATTEMPTS BUT THE SAME ISSUE CONTINUED. THE COMPLAINT COIL WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS REPORTED THAT THE PHYSICIAN SUSPECTED THE POSITION OF THE DETACHMENT MARKER MAY HAVE BEEN OUT OF POSITION BECAUSE THE COIL DID NOT COME OUT OF THE MICROCATHETER EVEN THOUGH THE REVERSE T EXCEEDED THE SECOND MICRO MARKER. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION AS A RESULT OF THE REPORTED PRODUCT ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12103691 ↗
• InjuryJun 9, 2021Entrapment of Device; Stretched; Positioning Problem; Premature Separation; Entrapment of Device; Stretched; Positioning Problem; Premature Separation

  A REPORT FROM THE FIELD INDICATED THAT DURING A COIL EMBOLIZATION AT THE SPLENIC ARTERY, A 7MM X 33CM DELTAFILL18 (DLF180733/30393933) WAS SELECTED FOR USE AS THE 13TH COIL, HOWEVER, RESISTANCE WAS ENCOUNTERED AS THE COIL WAS BEING ADVANCED INSIDE OF THE COIL MASS. THE PHYSICIAN ATTEMPTED TO RESHEATH THE COIL, BUT THE COIL BECAME UNRAVELED, AND THE DELIVERY AND COIL WERE DAMAGED/BROKEN. THE PHYSICIAN THEN REMOVED THE CONCOMITANT LEONIS MOVA (SUMITOMO BAKELITE) MICROCATHETER. DURING THIS MANEUVER, THE COIL, WHICH WAS PLACED IN THE BLOOD VESSEL, WAS PULLED WITH THE MICROCATHETER. THE COIL WAS ULTIMATELY LEFT IN THE PATIENT AT THE ABDOMINAL AORTA. THE PHYSICIAN PLANS TO FOLLOW-UP AND MONITOR THE UNRAVELED ¿THIN¿ COIL. THERE WAS NO REPORT OF PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED INDICATED THAT EXCESSIVE FORCE HAD NOT BEEN APPLIED TO THE DEVICE. THE DEVICE WAS REPORTEDLY USED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). NO FURTHER DETAILS COULD BE OBTAINED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11967216 ↗
• MalfunctionNov 12, 2020Premature Activation; Separation Failure; Premature Activation; Separation Failure

  AS REPORTED BY THE FIELD, DURING A COIL EMBOLIZATION, A 7MM X 33CM DELTAFILL18 (DLF180733, 30390732) WAS ATTEMPTED TO BE DETACHED BUT IT WAS NOT ABLE TO . THE COIL PART WAS DETACHED FROM THE DELIVERY WIRE AT THE SAME TIME THE COMPLAINT COIL ITSELF WAS REMOVED FROM THE PATIENT COMPLETELY. IT WAS REPLACED WITH ANOTHER COIL AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORT OF PATIENT INJURY. THE CUSTOMER STATES THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10828839 ↗
• MalfunctionJun 5, 2020Material Separation; Material Separation

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE ISOLATION COIL EMBOLIZATION PROCEDURE AT THE SPLENIC ARTERY, THE 7MM X 33CM DELTAFILL 18 COIL (DLF180733 / L17197) WAS USED, BUT IT WAS REPORTED THAT THERE WAS RESISTANCE FELT BETWEEN THE COMPLAINT COIL AND THE CONCOMITANT EXCELSIOR® 1018® MICROCATHETER (STRYKER). THE RESISTANCE WAS FELT WHEN THE COIL WAS BEING INSERTED INTO THE MICROCATHETER. THE COIL WAS RESHEATHED, BUT DURING THE RESHEATHING, THE COIL BECAME SEPARATED. THE PHYSICIAN REMOVED THE COIL AND THE CONCOMITANT MICROCATHETER TOGETHER. IT WAS REPORTED THAT PRIOR TO THIS COIL, OTHER COILS WERE INSERTED AND ADVANCED THROUGH THE SAME MICROCATHETER. CONTINOUS FLUSH HAD BEEN MAINTAINED THROUGH THE MICROCATHETER. ANOTHER EXCELSIOR® 1018® MICROCATHETER WAS USED AND ANOTHER DELTAFILL COIL AND A MICRUSFRAME 18 COIL WERE IMPLANTED, THE PROCEDURE WAS COMPLETED WITH THE MICRUSFRAME 18 COIL WITHOUT ANY FURTHER ISSUE. THERE NO FLOW RESTRICTION OR REDUCTION AS A RESULT OF THE REPORTED ISSUE; THE PROCEDURE WAS NOT PROLONGED. THERE WAS NO REPORT OF ANY PATIENT ADVERSE EVENT OR COMPLICATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10124113 ↗
• MalfunctionMar 11, 2019Separation Failure; Separation Failure

  THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING THE PERCUTANEOUS TRANSHEPATIC PORTAL EMBOLIZATION (PTPE) COIL EMBOLIZATION OF AN ANEURYSM AT THE PORTAL VEIN, THE 7MM X 33CM DELTAFILL 18 COIL (DLF180733/ S13335) UNDERWENT PRE-DEPLOYMENT ELECTRICAL TEST AND IT WAS CONFIRMED THAT THE LIGHT WAS ILLUMINATED; THE COIL WAS THEN DELIVERED TO THE TARGET LESION THROUGH THE EXCELSIOR® 1018 MICROCATHETER (STRYKER) AND THE PHYSICIAN ATTEMPTED TO DETACH THE COIL. A BEEP WAS HEARD FROM THE ENPOWER CONTROL CABLE (ECB00018200/ L14647), BUT THE COIL DELTAFILL 18 COIL WAS NOT DETACHED. THE ENPOWER CONTROL CABLE WAS REPLACED BUT THE ISSUE WAS NOT RESOLVED. AS A RESULT, THE PHYSICIAN REMOVED THE COIL FROM THE PATIENT AND REPLACED THE COIL. THE REPLACEMENT COIL DETACHED, 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

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8408564 ↗
• MalfunctionNov 15, 2018Off-Label Use; Stretched; Material Twisted/Bent; Premature Separation; Off-Label Use; Stretched; Material Twisted/Bent; Premature Separation

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING A PRE-STENT GRAFT COIL EMBOLIZATION OF AN ABDOMINAL AORTIC ANEURYSM AT THE RIGHT LUMBAR ARTERY, THE 7MM X 33CM DELTAFILL18 (DLF180733/S13156) THERMO-MECHANICAL COIL WAS INSERTED INTO THE PROGREAT (TERUMO) MICROCATHETER, BUT THE EMBOLIC COIL PREMATURELY DETACHED INSIDE OF THE MICROCATHETER. THE ISSUE REQUIRED THAT BOTH THE COIL AND MICROCATHETER BE REMOVED FROM THE PATIENT AS A UNIT. THE DETACHED EMBOLIC COIL WAS REMOVED FROM THE MICROCATHETER OUTSIDE OF THE PATIENT¿S BODY AND THE SAME MICROCATHETER WAS USED TO COMPLETE THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT OR DELAY. NO PATIENT COMPLICATIONS OCCURRED AS A RESULT OF THE EVENT. THE COMPLAINT PRODUCT WAS NEW 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 PRODUCT DEFECT/DAMAGE WAS NOTED PRIOR TO THE EVENT. THE CONCOMITANT MICROCATHETER WAS DELIVERED TO THE RIGHT LUMBAR ARTERY AND THE FIRST COIL (14MM X 47CM MICRUSFRAME18) AND SECOND COIL (12MM X 42CM DELTAFILL18) WERE IMPLANTED IN THE TARGET ANEURYSM. AN ENPOWER DCB2 DETACHMENT CON

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8073827 ↗
• MalfunctionFeb 23, 2018Unraveled Material; Unraveled Material

  AS REPORTED BY AN AFFILIATE, DURING A COIL EMBOLIZATION OF AN ANEURYSM (UNKNOWN SITE), IN ORDER TO POSITION A DELTAFILL18 COIL (DLF180733, S13156) THE PHYSICIAN WAS PLACING THE COIL IN AND OUT FROM THE ANEURYSM, BUT THE COIL BECAME UNRAVELED WHEN THE COIL WAS OUT. THE USER MANAGED TO COMPLETE THE EMBOLISM WITH THE COIL. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO PATIENT INJURY OR COMPLICATIONS REPORTED. THE PRODUCT IS NOT AVAILABLE FOR THE INVESTIGATION. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. NO VISIBLE DEFECT/DAMAGE WAS NOTED ON THE PRODUCTS PRIOR TO THE EVENT. NO UNINTENDED DETACHMENT WAS OBSERVED IN THE VESSEL OR IN THE MICROCATHETER. THE PATIENT¿S VESSEL WAS NOT TORTUROUS AND NOT CALCIFIED. THE (B)(4) WAS ALSO USED IN THIS PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7293285 ↗
• MalfunctionFeb 7, 2018Unraveled Material; Unraveled Material

  AS REPORTED BY AN AFFILIATE, DURING A COIL EMBOLIZATION OF AN ANEURYSM OF THE PELVIC ARTERIOVENOUS MALFORMATION, A DELTAFILL18 COIL (DLF180733, S13426) WAS INSERTED INTO THE MICRO CATHETER (130 CM BIRTAS, BOSTON) BUT RESISTANCE WAS FELT SLIGHTLY WHILE THE COIL WAS INSERTED INTO THE CATHETER AND EVENTUALLY STRONG RESISTANCE WAS FELT. WHEN THE COIL WAS BEING WITHDRAWN TO BE RE-SHEATH, THE COIL BECAME UNRAVELED IN THE MICRO CATHETER. THE COIL WAS REPLACED WITH ANOTHER ONE. THE PRODUCT IS NOT AVAILABLE FOR INVESTIGATION. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER ISSUES OR DELAY. THERE WAS NO PATIENT INJURY OR COMPLICATIONS REPORTED. THE PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTIONS. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU) AND CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIME. 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 FOLLOWING PRODUCTS WERE USED DURING THE PROCEDURE: TORNADO, COOK X 5, A GUIDING CATHETER (5FR DESTINATION), A MICRO CATHETER (130CM BIRTAS, BOSTON), A Y CONNECTOR (OK, GOODMAN) AND DCB02. THE PATIENT¿S VESSEL

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7247758 ↗
• MalfunctionApr 27, 2017Stretched; Stretched

  AS REPORTED BY A HEALTHCARE PROFESSIONAL, DURING COILING OF AN ANTERIOR COMMUNICATING ARTERY ANEURYSM IT WAS REPORTED THAT THE PHYSICIAN EXPERIENCED RESISTANCE WHEN USING TWO DELTAFILL 18 STRETCH RESISTANT COIL (7MM X 33CM). FIRST DELTAFILL 18 STRETCH RESISTANT COIL (7MM X 33CM) (LOT C41776) WAS TESTED FOR CONNECTIVITY PRIOR TO INSERTION INTO THE RHV. COIL WAS THEN FLUSHED IN THE RHV PER THE FLUSHING PROTOCOL. COIL WAS THEN LOADED INTO THE MICROCATHETER SEVERAL CENTIMETERS BEFORE RESISTANCE WAS FELT (APPROXIMATELY 12-16 INCHES). IT WAS DESCRIBED AS ¿BUCKLING¿ IN THE MICROCATHETER AS THE COIL COULD NO LONGER BE ADVANCED. COIL WAS REMOVED AND ANOTHER DELTAFILL 18 STRETCH RESISTANT COIL (7MMX33CM) (SAME LOT #) WAS SELECTED. SAME COIL PREP INSTRUCTIONS AND FLUSHING PROTOCOL WAS PERFORMED. ONCE AGAIN, THE COIL WAS LOADED INTO THE MICROCATHETER SEVERAL CENTIMETERS BEFORE RESISTANCE WAS FELT. SECOND DELTAFILL COIL WAS REMOVED AND PHYSICIAN COMPLETED PROCEDURE WITH STRYKER TARGET XL COIL USING THE SAME MICROCATHETER. THERE WERE NO DAMAGES NOTED ON THE COIL OR THE MICROCATHETER PRIOR TO USE OR UPON REMOVAL. THERE WERE NO SURGICAL DELAYS DUE TO THE REPORTED EVENT AND THERE WERE NO MEDICAL IN

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6525480 ↗