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EMBOLD™ Fibered M001394240020040Recalls & reported problems

Boston Scientific Corporation · Detachable Coil System · Class 2 · Implant

All models of EMBOLD Fibered (23)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
18
Deaths reported
0
Injuries reported
7
Recalls naming it
0

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 08714729983521), received between Sep 21, 2022 and Dec 22, 2025 — classified as 7 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Stretched” (8 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.

Reports received per month

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 1 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 1 reportsDec 2024: 0 reportsJan 2025: 2 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 4 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520264
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Stretched8
  • Break7
  • Difficult to Remove7
  • Adverse Event Without Identified Device or Use Problem5
  • Failure to Advance4
  • Malposition of Device4
  • Premature Activation4
  • Difficult to Advance3

Patient problems

  • No Clinical Signs, Symptoms or Conditions13
  • Foreign Body In Patient4
  • Vascular Dissection1
  • Vasoconstriction1

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 22, 2025Break; Stretched; Adverse Event Without Identified Device or Use Problem; Break; Stretched; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE COIL STRETCHED AND BROKE WITHIN THE PATIENT. AN EMBOLD FIBERED 2X4 WAS SELECTED FOR USE TO TREAT A BLEED IN THE LOWER GASTROINTESTINAL TRACT. THE TARGET LESION WAS LOCATED WITHIN A LESS THAN 2MM VESSEL. DURING THE PROCEDURE, THE COIL AND A TINY FRAGMENT OF THE COIL WIRE DETACHED IN THE PATIENT. THE PORTION OF THE COIL REMAINED IMPLANTED, AND THERE WAS NO REPORT OF ADDITIONAL INTERVENTION. THE PHYSICIAN STATED THERE WAS NO HARM CAUSED TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED DESPITE REQUEST BY BOSTON SCIENTIFIC.

    Patient problems: Foreign Body In Patient

    MAUDE report 23864544 ↗
  • MalfunctionDec 17, 2025Failure to Advance; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04DEC2025. IT WAS REPORTED THAT INADEQUATE PACKING AND FAILURE TO ADVANCE OCCURRED. A 2X4 EMBOLD FIBERED WAS SELECTED TO EMBOLIZE A LEFT GASTRIC ARTERY BLEED. ON FIRST DEPLOYMENT, THE COIL WOULD NOT FORM APPROPRIATELY. THE COIL WAS RECAPTURED IN THE SHEATH BUT THEN WOULD NOT ADVANCE FROM THE SHEATH FOR RE-DEPLOYMENT. THE COIL WAS REMOVED, AND A NEW 2X4 EMBOLD FIBERED COIL WAS USED TO FINISH CASE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED COIL SEPARATION AT THE PROXIMAL COUPLERS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23830740 ↗
  • MalfunctionDec 11, 2025Malposition of Device; Difficult or Delayed Separation; Malposition of Device; Difficult or Delayed Separation

    IT WAS REPORTED THAT THE COIL WAS MALPOSITIONED. THIS 2X4 EMBOLD FIBERED DEVICE WAS SELECTED FOR USE TO EMBOLIZE A BLEED IN THE GASTROEPIPLOIC ARTERY. DURING DEPLOYMENT, THE PROXIMAL RELEASE PERFORATION WAS BROKEN, AND THE PULL WIRE WAS RETRACTED, BUT THERE WAS A DELAY IN COIL DEPLOYMENT; ADDITIONAL ADVANCEMENT OF THE DELIVERY WIRE WAS NEEDED TO RELEASE THE COIL, BUT THE COIL SHIFTED. THE COIL DID NOT END UP IN THE EXACT INTENDED LOCATION; HOWEVER, THERE WAS NO NON-TARGET EMBOLIZATION. THE CASE WAS COMPLETED, AND THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT FULLY RECOVERED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23785259 ↗
  • MalfunctionDec 11, 2025Difficult to Remove; Malposition of Device; Difficult or Delayed Separation; Difficult to Remove; Malposition of Device; Difficult or Delayed Separation

    IT WAS REPORTED THAT THE COIL WAS MALPOSITIONED. THIS 2X4 EMBOLD FIBERED DEVICE WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE TO TREAT A BLEED. IT WAS NOTED THE TARGET LOCATION WAS MODERATELY TORTUOUS, AND THE VESSEL WAS NOT LESS THAN 1.5MM. AFTER BREAKING THE PROXIMAL RELEASE PERFORATION, RESISTANCE WAS ENCOUNTERED WHEN RETRACTING THE DETACHMENT (PULL) WIRE. THERE WAS A DELAY IN COIL DEPLOYMENT, AND THE COIL SHIFTED SLIGHTLY; HOWEVER, THE COIL DID NOT MOVE INTO A DIFFERENT ANATOMICAL LOCATION AND DID NOT CAUSE NON-TARGET EMBOLIZATION. THE CASE WAS COMPLETED, AND THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT FULLY RECOVERED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23785252 ↗
  • InjurySep 3, 2025Break; Difficult to Remove; Stretched; Failure to Advance; Break; Difficult to Remove; Stretched; Failure to Advance

    IT WAS REPORTED THAT THE COIL STRETCHED AND BROKE, AND SNARING WAS REQUIRED TO REMOVE THE DEVICE. A 2MM X 4CM EMBOLD? FIBERED COIL WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE TO TREAT A BLEED. DURING THE PROCEDURE, THE COIL STRETCHED AND UNRAVELED. AFTER THE COIL STRETCHED, IT COULD NOT BE ADVANCED OR RETRACTED. THE COIL WAS ABLE TO BE SNARED FROM THE PATIENT'S BODY. THE DEVICE BROKE INSIDE THE PATIENT AND WAS REMOVED IN MULTIPLE PIECES. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22953030 ↗
  • MalfunctionMar 6, 2025Break; Failure to Advance; Break; Failure to Advance

    IT WAS REPORTED THAT THE DEVICE MAY HAVE FRACTURED. THIS 2X4 EMBOLD FIBERED DEVICE WAS SELECTED FOR USE DURING A KIDNEY BIOPSY PROCEDURE. DURING THE PROCEDURE, THE COIL BECAME STUCK IN THE MIDDLE PART OF THE CATHETER. THE COIL WAS REMOVED ALONG WITH THE CATHETER, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT INJURY. IT WAS ADDITIONALLY NOTED THAT THERE WAS A POSSIBILITY THAT IT FRACTURED AT THE LOCKING SECTION. IT WAS ALSO REPORTED AS IT MAY HAVE TORN OFF AT THE LOCKING PART AT THE MIDDLE OF THE CATHETER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21537365 ↗
  • InjuryJan 14, 2025Stretched; Difficult to Advance; Material Protrusion/Extrusion; Adverse Event Without Identified Device or Use Problem; Stretched; Difficult to Advance; Material Protrusion/Extrusion; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE COIL WAS STRETCHED AND PROTRUDING FROM THE TARGET VESSEL, REQUIRING INTERVENTION. THIS 2X4 EMBOLD FIBERED WAS SELECTED FOR USE IN A HYPOGASTRIC BLEED PROCEDURE. A NON-BOSTON SCIENTIFIC MICROCATHETER WAS PLACED IN THE MILDLY TORTUOUS TARGET VESSEL. THE EMBOLD COIL WAS INSERTED INTO THE VESSEL AND WAS BELIEVED TO HAVE BEEN DEPLOYED. THEN THE PULL WIRE WAS RETRACTED OUTSIDE OF THE MICROCATHETER. A SECOND COIL WAS INSERTED INTO THE MICROCATHETER; HOWEVER, WAS UNABLE TO TRACK PAST THE TIP OF THE MICROCATHETER. ANGIOGRAPHY WAS PERFORMED WHICH REVEALED THE FIRST COIL WAS STRETCHED AND HANGING OUTSIDE OF THE TARGET VESSEL. A SNARE WAS USED TO REMOVE THE ENTIRE COIL. ACCESS WAS GAINED TO THE VESSEL AGAIN AND A DIFFERENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. IT WAS ALSO NOTED THAT THE COIL WAS DIFFICULT TO DEPLOY AS THE COUPLERS WERE NOT VISIBLE ONCE THE COIL WAS REMOVED. THERE WERE NO PATIENT COMPLICATIONS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21149377 ↗
  • InjuryJan 10, 2025Premature Activation; Stretched; Malposition of Device; Premature Activation; Stretched; Malposition of Device

    IT WAS REPORTED THAT THE COIL PREMATURELY DEPLOYED AND MALPOSITIONED, WHICH REQUIRED SNARING. A 2MM X 4CM EMBOLD FIBERED COIL WAS SELECTED FOR USE IN AN ADRENAL MYELOLIPOMA. AN ATTEMPT WAS MADE TO DEPLOY THE COIL THROUGH A 105CM TRUSELECT MICROCATHETER. THE AREA OF INTEREST WAS A BRANCH OF THE ADRENAL. THE PHYSICIAN DID NOT LIKE THE COIL'S POSITION, SO AN ATTEMPT WAS MADE TO RETRACT THE COIL, BUT ONLY THE DELIVERY WIRE CAME BACK, NOT THE COIL ITSELF. NO RESISTANCE WAS FELT WHEN TRYING TO PULL THE COIL BACK, AND THE PROXIMAL RELEASE PERFORATION WAS NOT SNAPPED AND REMAINED INTACT. AN 016 COIL PUSHER WAS USED TO TRY AND PUSH THE COIL OUT, BUT THIS WAS UNSUCCESSFUL. THE MICROCATHETER WAS ABLE TO BE REMOVED, BUT THE COIL AND STRING FROM THE DELIVERY WIRE WERE STILL IN THE BASE CATHETER. A NON-BOSTON SCIENTIFIC GUIDEWIRE WAS USED TO TRY AND PUSH THE COIL THROUGH. IT LOOKED BETTER, BUT THE STRING WAS STILL IN THE BASE CATHETER. WHILE ATTEMPTING TO REMOVE THE GUIDEWIRE, THE BASE CATHETER FLIPPED THE COIL INTO THE AORTA. CONTRALATERAL ACCESS WAS OBTAINED IN ORDER TO SNARE OUT THE COIL AND STRING. THE PATIENT WAS HEMODYNAMICALLY STABLE, AND THERE WERE NO COMPLICATIONS POST CASE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21125271 ↗
  • InjuryNov 6, 2024Difficult to Remove; Stretched; Malposition of Device; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Stretched; Malposition of Device; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT THE COIL WAS MALPOSITIONED, REQUIRING SNARING, AND VESSEL SPASM OCCURRED, REQUIRING MEDICATIONS. THIS 2X4 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN A PHRENIC ARTERY EMBOLIZATION PROCEDURE. IT WAS NOTED THAT THE VESSEL WAS MODERATELY TORTUOUS. DURING THE PROCEDURE, THE COIL WAS ADVANCED THROUGH A 2F TRUSELECT MICROCATHETER INTO A SUB-2MM PHRENIC ARTERY BRANCH. AFTER BEING ADVANCED APPROXIMATELY 2 CM INTO THE MICROCATHETER, SIGNIFICANT RESISTANCE WAS FELT, AND IT WAS DIFFICULT TO ADVANCE THE COIL. ADDITIONALLY, VESSEL SPASM WAS OBSERVED AT THAT TIME. THE PATIENT RECEIVED NITROGLYCERIN IN ORDER TO IMPROVE THE VESSEL SPASM. AN ATTEMPT WAS MADE TO PUSH AND RETRACT THE COIL SEVERAL TIMES, AND WHEN ATTEMPTING TO RESHEATH THE COIL, THE COIL WOULD NOT RETRACT INTO THE SHEATH. THE MICROCATHETER WAS REMOVED; HOWEVER, THE COIL REMAINED IN THE PHRENIC ARTERY BRANCH AND WAS NOTED TO HAVE STRETCHED. A SNARE WAS THEN USED TO REMOVE THE COIL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT EMBOLD DEVICE AND THERE WERE NO PATIENT COMPLICATIONS.

    Patient problems: Vasoconstriction

    MAUDE report 20622745 ↗
  • InjuryOct 17, 2024Positioning Problem; Positioning Problem

    IT WAS REPORTED THAT VESSEL DISSECTION OCCURRED. A 2MM X 4CM EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN A LOWER GASTROINTESTINAL BLEED EMBOLIZATION PROCEDURE. AN ATTEMPT WAS MADE TO EMBOLIZE A SMALL BRANCH OFF THE SUPERIOR MESENTERIC ARTERY (SMA). THE VESSEL WAS MODERATELY TORTUOUS. A 130CM TRUSELECT MICROCATHETER WITH A BERN TIP AND A FATHOM 16 GUIDEWIRE WERE USED TO SELECT THE VESSEL. AN ANGIOGRAM WAS PERFORMED, AND THE BLEEDING VESSEL WAS IDENTIFIED. THE CALIBER OF THE VESSEL MEASURED 3MM, SO THE PHYSICIAN OPTED FOR A 3MM X 6CM EMBOLD FIBERED DETACHABLE COIL SYSTEM. THERE WAS NO RESISTANCE DURING ADVANCEMENT OF THE COIL. ONCE THE COIL EXITED THE TRUSELECT, IT STARTED TO FORM AS IT SHOULD. APPROXIMATELY 1/2 OF THE COIL WAS DEPLOYED WHEN IT KICKED THE TRUSELECT BACK. ATTEMPTS WERE MADE TO REPOSITION AND RETRACT THE COIL TO GET IT TO SEAT BETTER, BUT THIS METHOD WAS UNSUCCESSFUL, AND ACCESS TO THE VESSEL WITH THE TRUSELECT WAS LOST. THE 3MM X 6CM EMBOLD COIL WAS RECAPTURED WITHOUT DIFFICULTY. ANOTHER ANGIOGRAM WAS TAKEN, AND IT WAS NOTICED THE VESSEL SPASMED A LITTLE. THE PHYSICIAN REGAINED ACCESS TO THE VESSEL WITH THE FATHOM GUIDEWIRE AND THE TRUSELECT AND DECI

    Patient problems: Vascular Dissection

    MAUDE report 20472154 ↗
  • MalfunctionAug 12, 2024Premature Activation; Difficult to Advance; Premature Activation; Difficult to Advance

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19JULY2024. IT WAS REPORTED THAT DIFFICULTY ADVANCING AND PREMATURE DEPLOYMENT IN CATHETER OCCURRED. A 2X4 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR AN EMBOLIZATION PROCEDURE OF AN ACCESSORY LEFT GASTRIC ARTERY FOR ARTERIAL MAPPING FOR Y90 ADMINISTRATION. THE VESSEL WAS MILD TO MODERATELY TORTUOUS. THE FIRST COIL WAS PUSHED APPROXIMATELY HALF WAY THROUGH THE 2.8FR X 150CM NON-BOSTON SCIENTIFIC CATHETER, WITH DIFFICULTY. THE WIRE WAS REMOVED, AND IT WAS DISCOVERED THAT THE COIL PREMATURELY DEPLOYED IN THE MICROCATHETER. THE MICROCATHETER WAS REMOVED AND CLEARED. AN EMBOLD FIBERED 3X6 WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED A DETACHED COIL.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19963322 ↗
  • MalfunctionJul 10, 2024Break; Premature Activation; Break; Premature Activation

    IT WAS REPORTED THAT THE COIL BROKE IN THE MICROCATHETER. A 2X4 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR A PROSTATE ARTERY EMBOLIZATION. THE COIL BROKE WITHIN THE MICROCATHETER AND HAD TO BE PUSHED OUT INTO THE BODY WITH THE WIRE. IT WAS FURTHER REPORTED THAT ANATOMICAL LOCATION WAS A PROSTATE ARTERY WITH SOME TORTUOSITY. THE COIL HAD A SLIGHT RESISTANCE RIGHT BEFORE IT HAD PREMATURELY DEPLOYED WITHIN THE MICROCATHETER. THE COIL DID NOT BREAK. IT WAS ABLE TO BE PUSHED OUT WITH THE PUSHER WIRE, AND THERE WAS NO CONCERN FOR NON-TARGET EMBOLIZATION. THE PATIENT OUTCOME WAS GOOD, AND THEY WENT HOME WITHOUT COMPLICATIONS ON THE SAME DAY.

    Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

    MAUDE report 19713100 ↗
  • InjuryMay 2, 2024Break; Difficult to Remove; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Break; Difficult to Remove; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THE INNER WIRE BROKE AND REMAINED INSIDE THE PATIENT. THIS EMBOLD FIBERED DETACHABLE COIL SYSTEM 2 X 4 WAS SELECTED FOR EMBOLISM OF A HEMORRHAGE. DURING THE PROCEDURE, THE COIL WASN'T DEPLOYING PROPERLY (WAS NOT TAKING SHAPE). THE PHYSICIAN ATTEMPTED TO RECONSTRAIN THE COIL; HOWEVER, THE INNER PULL WIRE BROKE WITHIN THE DELIVERY WIRE. THE COIL AND A GOOD PORTION OF THE PULL WIRE REMAINED INSIDE THE PATIENT WITH NO WAY TO RETRIEVE IT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: Foreign Body In Patient

    MAUDE report 19229559 ↗
  • InjuryFeb 21, 2024Break; Stretched; Material Protrusion/Extrusion; Break; Stretched; Material Protrusion/Extrusion

    IT WAS REPORTED THAT THE COIL STRETCHED FROM THE TARGET LOCATION AND SNARING WAS REQUIRED. A 2X4 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN THE EMBOLIZATION OF THE LEFT RENAL ARTERY. THE COIL WAS DEPLOYED. MOST OF THE COIL WAS IN THE TARGET LOCATION, BUT SOME OF THE COIL WAS STRETCHED AND PROTRUDING OUT OF THE TARGET LOCATION. PARTS OF THE COIL WERE GRABBED BY A SNARE AND PULLED OUT OF THE PATIENT. SOME PIECES OF THE COIL WERE LEFT INSIDE THE PATIENT IN THE TARGET AREA. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: Foreign Body In Patient

    MAUDE report 18752042 ↗
  • MalfunctionNov 22, 2023Separation Failure; Separation Failure

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01NOV2023. IT WAS REPORTED THAT THE DEVICE DID NOT DEPLOY. THE TARGET LOCATION WAS IN THE PROSTATE ARTERY. A 2X4 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL DID NOT DEPLOY. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THE COIL WIRE WAS SEPARATED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18191594 ↗
  • MalfunctionAug 11, 2023Difficult to Remove; Stretched; Difficult to Remove; Stretched

    REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT THE DEVICE STRETCHED AND BECAME LODGED IN THE CATHETER. A 2X4 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO RETRACT THE COIL; HOWEVER, THE COIL STRETCHED AND BECAME LODGED IN THE MICRO CATHETER. THE CATHETER WAS REMOVED AND THE COIL WAS RETRIEVED. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED THE COIL WAS SEPARATED FROM THE DISTAL COUPLER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17509073 ↗
  • MalfunctionMay 15, 2023Premature Activation; Difficult to Remove; Stretched; Material Integrity Problem; Material Protrusion/Extrusion; Premature Activation; Difficult to Remove; Stretched; Material Integrity Problem; Material Protrusion/Extrusion

    IT WAS REPORTED THAT THE COIL WAS PROTRUDING FROM THE TARGET LOCATION. A 2X4 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN A RENAL EMBOLIZATION PROCEDURE. DURING PLACEMENT, AN ATTEMPT WAS MADE TO RETRACT THE COIL BECAUSE IT WAS NOT FORMING IN A MANNER THEY PREFERRED, BUT THERE WAS DIFFICULTY RETRACTING THE COIL. THE RELEASE MECHANISM WASN'T BROKEN, BUT SOMEHOW IT BECAME DETACHED, AND THE COIL PREMATURELY DEPLOYED. ONCE THE MICROCATHETER WAS REMOVED, IT WAS OBSERVED THAT THERE WAS A TAIL COMING FROM THE COIL. THE COIL WAS STRETCHED AND PROTRUDING FROM THE TARGET LOCATION. NOTHING WAS DONE TO CORRECT THE COIL'S PLACEMENT. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16932450 ↗
  • MalfunctionSep 21, 2022Break; Difficult to Remove; Failure to Advance; Break; Difficult to Remove; Failure to Advance

    IT WAS REPORTED THAT THE COIL DETACHED. THE TARGET LESION WAS LOCATED IN THE 1MM EXTREMELY TORTUOUS PROSTATE ARTERY. A 2X4 EMBOLD FIBERED DETACHABLE COIL SYSTEM WAS SELECTED FOR USE IN A COMPLEX EMBOLIZATION PROCEDURE. A 130 TRUSELECT MICROCATHETER WAS ADVANCE TO THE VESSEL. THE COIL WAS PUSHED OUT OF THE MICROCATHETER; HOWEVER, THE PHYSICIAN DID NOT LIKE THE POSITION SO THE COIL WAS PULLED BACK IN TO REPOSITION. DURING REPOSITIONING, THE COIL WAS UNABLE TO BE MOVED FORWARD WITHIN THE MICROCATHETER. RESISTANCE OCCURRED THROUGH OUT THE DELIVERY. THE COIL WIRE WAS PULLED OUT AND IT WAS NOTED THAT THE COIL WAS DETACHED. THE COIL WAS UNABLE TO BE REMOVED FROM THE MICROCATHETER SO THE CATHETER WAS PULLED OUT AS WELL. LIQUID EMBOLIC WAS GIVEN PRIOR TO THE COIL ATTEMPT. THE PHYSICIAN NOTED THAT THERE COULD HAVE BEEN SPASMING IN THE VESSEL CAUSING THE COIL DETACHMENT. THERE WERE NO PATIENT COMPLICATIONS.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15461548 ↗

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