TARGET XL M0036121040Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 07613327004601), received between Jul 19, 2016 and Nov 21, 2025 — classified as 9 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Fracture” (12 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 32 reports, in the reporter's own words as published by the FDA.

• InjuryNov 21, 2025Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING CEREBRAL ANEURYSM EMBOLIZATION, ENDOVASCULAR INTERVENTIONAL PROCEDURE, THERE WAS STRETCHING OF THE SUBJECT COIL, RESULTING IN DETACHMENT FROM THE PUSHER AND INABILITY TO RECAPTURE IT. THE PRIMARY NYLON FILAMENT CAME OUT OF THE COIL. THE COIL AND NYLON REMAINED IN THE PATIENT'S LEFT CAROTID ARTERY, AORTA, AND RIGHT ILIAC-FEMORAL AXIS. THE PATIENT EXPERIENCED RIGHT UPPER LIMB PARESIS AND MILD DYSARTHRIA. THE PATIENT AWOKE WITH MILD PALSY OF THE SEVENTH CEREBRAL ARTERY, MILD DYSARTHRIA, AND PLEGIA IN THE RIGHT UPPER LIMB. OVER THE NEXT 6 DAYS, THERE WAS A MARKED IMPROVEMENT IN HER CLINICAL CONDITION: COMPLETE RESOLUTION OF THE DYSARTHRIA AND SEVENTH CEREBRAL ARTERY PALSY, PARTIAL RESOLUTION OF THE PLEGIA IN THE RIGHT UPPER LIMB, AND A COMPLETE MOTOR DEFICIT IN THE HAND.

  Patient problems: Foreign Body In Patient; Paresis; Speech Disorder

  MAUDE report 23623640 ↗
• InjuryNov 20, 2025Fracture; Expulsion; Fracture; Expulsion

  IT WAS REPORTED THAT DURING ANEURYSM EMBOLIZATION CASE, THE OPERATOR REPORTED RESISTANCE WHILE ADVANCING THE SUBJECT COIL THROUGH THE MICROCATHETER. THE COIL WAS EVENTUALLY DEPLOYED ENTIRELY WITHIN THE ANEURYSM SAC. AFTER APPROXIMATELY FIVE MINUTES, THE OPERATOR DECIDED TO REPOSITION THE COIL. DURING RETRIEVAL, THE PUSHER WIRE BECAME FLOPPY AND SUBSEQUENTLY FRACTURED. THE COIL WAS THEN RE-ADVANCED INTO THE SAC; HOWEVER, APPROXIMATELY 5 MM OF THE COIL REMAINED OUTSIDE. DETACHMENT COULD NOT BE ACHIEVED, AS THE DETACHMENT ZONE OF THE PUSHER WIRE HAD SEPARATED FROM THE REMAINDER OF THE SYSTEM. TO RETRIEVE THE RESIDUAL COIL MASS, THE OPERATOR ATTEMPTED TO TRAP IT USING THE PREVIOUSLY DEPLOYED COIL-ASSISTED FLOW DIVERTER. THIS APPROACH WAS INITIALLY SUCCESSFUL UNTIL THE FLOW DIVERTER¿S PUSHER WIRE DETACHED, LEAVING THE DEVICE WITHIN THE COMMON CAROTID ARTERY. AFTER MULTIPLE RETRIEVAL ATTEMPTS USING VARIOUS STENT RETRIEVERS AND GOOSENECK SNARES, THE PHYSICIAN SUCCESSFULLY REMOVED THE FLOW DIVERTER AND MOST OF THE STRETCHED COIL. DESPITE SEVERAL ADDITIONAL HOURS OF EFFORT, A PORTION OF THE COIL FRAGMENTS WITHIN THE ANEURYSM SAC COULD NOT BE RETRIEVED. THE PROCEDURE WAS SUBSEQUENTLY COMPLET

  Patient problems: Foreign Body In Patient

  MAUDE report 23605033 ↗
• MalfunctionOct 7, 2025Premature Separation; Premature Separation

  IT WAS REPORTED DURING THE PROCEDURE THE SUBJECT COIL STRETCHED AND PREMATURELY DETACHED INSIDE THE ANEURYSM. THE COIL WAS REMOVED, CAUSING A 20 MINUTE SURGICAL DELAY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23237773 ↗
• InjurySep 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A COILING PROCEDURE, RESISTANCE WAS ENCOUNTERED WHILE ADVANCING THE SUBJECT COIL THROUGH THE INTRODUCER SHEATH, AND THE SUBJECT COIL WAS NOT MOVED AS INTENDED WHILE REPOSITIONING FOR FRAMING THE ANEURYSM. TO RETRIEVE THE SUBJECT COIL, THE HUB OF THE CATHETERS WAS CUT, AND A SNARE DEVICE WAS INSERTED FROM A STRYKER CATHETER SINCE PULLING BACK THE DELIVERY WIRE WAS NOT CONSIDERED EFFECTIVE. WHILE GUIDING THE SNARE, THE COIL WAS INTENTIONALLY MOVED. A COIL STRETCH WAS CONFIRMED OUTSIDE THE PATIENT DURING INSPECTION AFTER RETRIEVAL. THE COIL WAS LOCATED IN THE ANEURYSM AT THE TIME THE SNARE WAS USED. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23135085 ↗
• MalfunctionDec 6, 2024Fracture; Fracture

  IT WAS REPORTED THAT WHEN THE SUBJECT COIL WAS USED FOR EMBOLIZATION OF AN ARTERIOVENOUS SHUNT DUE TO INTERRUPTION OF SHUNT BLOOD FLOW AFTER THE SURGERY, THE SUBJECT COIL WAS INSERTED INTO THE BODY; HOWEVER, IT WAS RETRIEVED BECAUSE IT WAS UNDERSIZED FOR THE TARGET SITE. AFTER IMPLANTING AN OVERSIZED COIL, THE SUBJECT COIL WAS ATTEMPTED TO BE REINSERTED. ALTHOUGH THE ASSISTANT DOCTOR KINKED THE PROXIMAL PART OF THE SUBJECT COIL DELIVERY WIRE, WHEN RETRACTING THE SUBJECT COIL INTO THE SHEATH, IT WAS USED AS IT WAS. RESULTED PREMATURELY DETACHMENT OF THE DELIVERY WIRE WHEN 2/3 OF THE TOTAL LENGTH OF THE SUBJECT COIL WAS INSERTED. THE DELIVERY WIRE WAS RETRIEVED AS IT WAS BECAUSE THERE WAS A PREMATURELY DETACHED PART OF THE PROXIMAL PART OF THE DELIVERY WIRE IN THE HUB OF THE MICROCATHETER. THE SUBJECT COIL WAS SAFELY REMOVED FROM THE BODY WITHOUT STRETCHING. IT WAS ALSO, REPORTED THAT THE SUBJECT COIL ENCOUNTERED RESISTANCE INSIDE THE CATHETER. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20862537 ↗
• InjuryNov 11, 2024Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event; Adverse Event Without Identified Device or Use Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT THE PATIENT HAD RIGHT OCCIPITAL ISCHEMIC STROKE AND LOSS OF VISION ON THE LEFT EYE POST PROCEDURE ON (B)(6) 2024 AS THE INITIAL PROCEDURE WAS SUCCESSFULLY COMPLETED ON (B)(6) 2024. THE PATIENT WAS HOSPITALIZED AND WAS TREATED WITH THE MEDICATION (ASPIRIN) AS NO MEDICAL INTERVENTION WAS REQUIRED. THE OUTCOME OF THIS ADVERSE EVENT WAS RESOLVED, WITH SEQUELAE. PER THE MEDICAL RECORD, THE PATIENT HAS RIGHT-SIDED HEMIANOPIA BUT OTHERWISE NO OTHER DEFICITS ARE KNOWN. FROM A MEDICAL OPINION PERSPECTIVE, THE CAUSE OF THE STROKE POST PROCEDURE WAS UNKNOWN ETIOLOGY-POSSIBLY ACUTE COCAINE VASCULOPATHY, CLOT DISLODGEMENT FROM ANEURYSM INTO THE PCA, IMPEDED FLOW IN THE VESSELS SURROUNDING THE TARGET ANEURYSM RELATED TO THE INDEX TREATMENT. IN PHYSICIAN¿S OPINION, THE SUBJECT DEVICE PERFORMED AS INTENDED AND THERE WERE NO ALLEGATIONS AGAINST IT. BASED ON THE ADDITIONAL INFORMATION RECEIVED FROM SAFETY ON 17-DEC-2024 THAT THE SITE ALSO UPDATED THE RELATEDNESS SECTION AND ACCORDING TO THIS UPDATE, THIS EVENT WAS NOT RELATED TO SUBJECT DEVICE. THIS IS CONSISTENT WITH THE RESULTS OF CEC ADJUDICATIONS. IN PHYSICIAN¿S OPINION, THE SUBJECT COIL DEVICE PERFORMED AS INTENDED AND THER

  Patient problems: Loss of Vision; No Clinical Signs, Symptoms or Conditions; Stroke/CVA

  MAUDE report 20658703 ↗
• MalfunctionAug 22, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING INTERNAL CAROTID ARTERY COIL EMBOLIZATION PROCEDURE, RESISTANCE WAS FELT WHILE ADVANCING SUBJECT COIL IN THE SHAFT OF MICROCATHETER. IT WAS THEN DECIDED TO RETRIEVE AND UPON REMOVAL FROM THE PATIENT'S BODY, THE PROXIMAL END OF THE SUBJECT COIL WAS FOUND TO BE BROKEN AND STRETCHED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE. PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20033184 ↗
• MalfunctionAug 8, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING EMBOLIZATION PROCEDURE OF AN INTRA-ABDOMINAL HEMORRHAGE DUE TO A RUPTURED VARICOSE VEIN, THE OPERATOR PERFORMED EMBOLIZATION WITH TWO COILS AND N-BUTYL CYANOACRYLATE (NBCA). NEXT, THE SUBJECT COIL WAS USED. HOWEVER, A RESISTANCE INSIDE THE MICROCATHETER SHAFT WAS ENCOUNTERED AND THE SUBJECT COIL DELIVERY WIRE BROKE DURING THE PROCEDURE. THE SUBJECT COIL WAS REMOVED FROM THE PATIENT'S ANATOMY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19944429 ↗
• MalfunctionJul 23, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT COIL WAS USED AT THE TWELFTH COIL. WHILE BEING PUSHED AND PULLED TO FOLD IT IN THE SUBJECT COIL TORE DURING USE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19810968 ↗
• MalfunctionJul 1, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ANTERIOR COMMUNICATING ARTERY UNRUPTURED ANEURYSM COIL EMBOLIZATION PROCEDURE, PHYSICIAN DEPLOYED A STENT AND THEN INSERTED THE SUBJECT COIL INTO THE MICROCATHETER, HOWEVER RESISTANCE WAS ENCOUNTERED AT THE MIDDLE OF THE CATHETER SHAFT. PHYSICIAN TRIED TO RETRIEVE THE SUBJECT COIL HOWEVER, THE SUBJECT COIL BROKE OFF. THUS, THE ENTIRE MICROCATHETER WAS REMOVED. THE SUBJECT COIL WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19644981 ↗
• MalfunctionMar 18, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING AN ANEURYSM PROCEDURE, OPERATOR HAD DIFFICULTY POSITIONING THE SUBJECT COIL IN THE TARGET LOCATION, AND IT COULD NOT BE RETRACTED. THEREFORE, THE SUBJECT COIL ALONG WITH THE MICROCATHETER WAS REMOVED FROM THE PATIENT¿S BODY AND THE SUBJECT COIL WAS FOUND STRETCHED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER DEVICE. THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT COIL DELIVERY WIRE WAS FOUND TO BE BROKEN/FRACTURED DURING USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18926794 ↗
• MalfunctionDec 4, 2023Fracture; Fracture

  THE SUBJECT COIL WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE SUBJECT COIL WAS BROKEN/FRACTURED DURING USE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18258952 ↗
• MalfunctionSep 6, 2023Premature Separation; Premature Separation

  IT WAS REPORTED THAT TAE (TRANS ARTERIAL EMBOLIZATION ) WAS PERFORMED FOR CHA (COMMON HEPATIC ARTERY) ANEURYSM. DURING PROCEDURE RESISTANCE WAS ENCOUNTERED WHEN THE SUBJECT COIL WAS ATTEMPTED TO BE PLACED INSIDE THE ANEURYSM FROM A NON-STRYKER MICROCATHETER BREAKTHROUGH. THEREFORE, THE SUBJECT COIL WAS RETRIEVED, RESULTING PREMATURELY DETACHED WITHIN THE MICROCATHETER. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17695627 ↗
• MalfunctionFeb 14, 2023Fracture; Premature Separation; Fracture; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE REVEALED THAT SUBJECT MAIN COIL PREMATURELY DETACHED/SEPARATED DURING USE AND SUBJECT MAIN COIL BROKEN/FRACTURED DURING USE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16376039 ↗
• MalfunctionDec 28, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE PHYSICIAN REPOSITIONED THE SUBJECT COIL SEVERAL TIMES BUT IT KEPT COMING OUT OF THE VESSEL AND WHEN NO RESISTANCE WAS FELT, IT WAS FOUND THAT THE SUBJECT COIL HAD PREMATURELY DETACHED FROM THE DELIVERY WIRE. A SNARE DEVICE WAS USED TO RETRIEVE THE COIL. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16060892 ↗
• MalfunctionOct 24, 2022Fracture; Fracture

  IT WAS INITIALLY REPORTED THAT THE SUBJECT COIL COULD NOT BE DETACHED. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT. ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE SUBJECT DEVICE WAS BROKEN/FRACTURED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15660540 ↗
• MalfunctionAug 8, 2022Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT COIL WAS PREMATURELY DETACHED DURING FILLING IN THE MASS. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THE REPORTED EVENT. NO OTHER INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15189005 ↗
• InjuryJun 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM EMBOLIZATION PROCEDURE, THE SUBJECT COIL WAS DELIVERED VIA THE MICROCATHETER INTO THE ANEURYSM. AT SOME POINT, THE SUBJECT COIL WAS NOT ABLE TO ADVANCE AND NOT FULLY INSERTED INTO THE ANEURYSM. THE NEXT STEP WAS TO WITHDRAW THE WHOLE SUBJECT COIL INTO THE MICROCATHETER. UPON WITHDRAWN, THE SUBJECT COIL WAS STRETCHED AND WAS NOTED TO BE BROKEN INTO TWO PARTS. MOST OF THE SUBJECT COIL WAS WITHDRAWN WITH THE MICROCATHETER BUT THE BROKEN/STRETCHED DISTAL PART OF THE SUBJECT COIL REMAINED INSIDE THE PATIENT¿S VESSEL. IT WAS OBSERVED THAT THE THIN FIBER ROLLED TO A "BALL OF FIBERS" AND THIS BALL WAS REMOVED SUCCESSFULLY WITH A SNARE DEVICE. PATIENT WAS SET UNDER ASS AND IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14569647 ↗
• MalfunctionOct 26, 2021Premature Separation; Premature Separation

  ANALYSIS OF THE RETURNED DEVICE FOUND THE MAIN COIL PREMATURELY DETACHED/SEPARATED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12695826 ↗
• MalfunctionMay 17, 2021Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING A PROCEDURE IN THE LEFT ANTERIOR COMMUNICATING ARTERY, THE PHYSICIAN SUCCESSFULLY CATHETERIZED THE ANEURYSM WITH A MICRO CATHETER. THE GUIDE WIRE WAS RETRACTED AND THE FIRST SUBJECT COIL WAS LOADED INTO THE MICRO CATHETER, BUT AFTER ADVANCING APPROXIMATELY ONE OR TWO THIRDS IN THE MICROCATHETER SHAFT, IT GOT STUCK IN THE MICRO CATHETER. WHEN THE PHYSICIAN TRIED TO PULL BACK THE SUBJECT COIL, IT DETACHED IN THE MICRO CATHETER AND BOTH DEVICES WERE REMOVED AND REPLACED WITH SIMILAR DEVICES. THE SAME EVENT HAPPENED WITH THE SECOND AND THIRD SET OF REPLACEMENT DEVICES AND CAUSED A 30 MINUTE SURGICAL DELAY. THE PHYSICIAN REMOVED THEM AND REPLACED WITH SIMILAR DEVICES TO COMPLETE THE PROCEDURE WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11830555 ↗
• MalfunctionSep 10, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE SUBJECT DEVICE COIL WAS PUSHED AND PULLED FOR PLACING, IT WAS PREMATURELY DETACHED. THE SUBJECT COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10512609 ↗
• MalfunctionAug 3, 2020Fracture; Migration; Fracture; Migration

  IT WAS REPORTED THAT DURING THE PROCEDURE, THE COIL (SUBJECT DEVICE) MIGRATED FROM THE IMPLANTED TARGET LOCATION. WHEN THE PHYSICIAN ATTEMPTED TO PLACE THE SUBJECT COIL BACK IN THE TARGET LOCATION, IT GOT STUCK AND STRETCHED. IT WAS OBSERVED THAT THE TIP OF THE SUBJECT COIL WAS BROKEN DURING THE MANIPULATION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient

  MAUDE report 10360018 ↗
• MalfunctionJul 6, 2020Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING THE PROCEDURE THE PHYSICIAN TRIED TO INSERT THE SUBJECT COIL INTO THE MICROCATHETER AND THE SUBJECT COIL PREMATURELY DETACHED WHILE IT WAS INSIDE THE PATIENT. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10237411 ↗
• MalfunctionDec 11, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT WHEN THE COIL (SUBJECT DEVICE) WAS INSERTED INTO THE MICROCATHETER THERE WAS RESISTANCE AND THE COIL DETACHED INSIDE THE CATHETER. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9451440 ↗
• MalfunctionDec 10, 2019Premature Separation; Premature Separation

  IT WAS REPORTED THAT DURING PROCEDURE, WHILE THE PHYSICIAN WAS RE-POSITIONING THE COIL (SUBJECT DEVICE) INSIDE THE ANEURYSM AND WANTED TO PULL THE COIL OUT AGAIN, THE MAIN COIL PREMATURELY DETACHED AT DETACHMENT ZONE PRIOR TO DETACHMENT PROCESS. SINCE THE COIL WAS STILL WITH THE COIL DELIVERY WIRE WITHIN THE MICRO-CATHETER, THE PHYSICIAN JUST PUSHED THE END OF THE COIL INTO THE ANEURYSM. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9447378 ↗