Interlock™ M001361600Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 08714729765035), received between Jan 15, 2019 and Apr 23, 2026 — classified as 4 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (7 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.

• MalfunctionApr 23, 2026Difficult to Remove; Stretched; Separation Failure; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT COIL FAILED TO SEPARATE AND STRETCH OCCURRED. THE TARGET LESION WAS LOCATED IN THE PELVIC VEINS. A 2D 10MM X 30CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS FOUND THAT THE COIL COULD NOT BE DEPLOYED AND PULLED OUT. UPON RETRIEVAL OF THE COIL, IT WAS OBSERVED TO BE VERY TIGHT AND HAD BEEN STRETCHED DURING REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED AN ARM COIL DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971613 ↗
• MalfunctionApr 24, 2025Premature Activation; Difficult to Remove; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Premature Activation; Difficult to Remove; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01APR2025. IT WAS REPORTED THAT COIL WAS UNABLE TO ADVANCE IN THE MICROCATHETER. A 10MM X 30CM INTERLOCK WAS SELECTED FOR USE IN A PULMONARY ARTERIOVENOUS FISTULA. DURING THE PROCEDURE, WHEN THE COIL WAS PUSHED TO ABOUT 1/3 OF THE NON-BOSTON SCIENTIFIC MICROCATHETER, THE COIL COULD NOT BE PUSHED AND WAS DIFFICULT TO WITHDRAW. REPEATED ADJUSTMENT RESULTED IN PREMATURE DEPLOYMENT OF THE COIL INSIDE THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED ARM COIL DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21902471 ↗
• InjuryAug 14, 2024Premature Activation; Stretched; Separation Failure; Adverse Event Without Identified Device or Use Problem; Premature Activation; Stretched; Separation Failure; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN INTERVENTION WAS PERFORMED TO REMOVE THE COIL. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY ANEURYSM. A 10MM X 30CM 2D INTERLOCK COIL WAS ADVANCED FOR TREATMENT. DURING THE PROCEDURE, THE COIL WAS FLUSHED AND DELIVERED USING AN STC 18 MICROCATHETER. WHEN THE COIL WAS DELIVERED, IT COULD NOT BE RELEASE, AND IT WAS STRETCHED. THE COIL COULD NOT BE WITHDRAWN WITH THE CATHETER, SO THE PHYSICIAN REMOVED THE CATHETER FIRST AND THEN USED A SNARE TO REMOVE THE SPRING COIL. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE. IT WAS FURTHER REPORTED THAT THE LESION WAS MODERATELY TORTUOUS AND NON-CALCIFIED ARTERY. THE COIL WAS DETACHED INSIDE THE MICROCATHETER, WHICH COULD NOT BE ADVANCED OR WITHDRAWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19987950 ↗
• MalfunctionFeb 29, 2024Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09FEB2024. IT WAS REPORTED THAT THE COIL COULD NOT BE PUSHED IN THE MIDDLE OF THE ANGIOGRAPHY CATHETER. THE TARGET LESION WAS LOCATED IN THE GASTRIC FUNDUS VEIN. A 10MM X 30CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS ADVANCED INTO STC MICROCATHETER AND IT WAS FOUND OUT THAT THE COIL COULD NOT BE PUSHED IN THE MIDDLE OF ANGIOGRAPHY CATHETER. RE-FLUSHING WITH HEPARIN SALINE WAS DONE BUT SAME ISSUE OCCURRED. THE COIL WAS WITHDRAWN, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE MAIN COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18807476 ↗
• MalfunctionFeb 14, 2024Break; Difficult to Remove; Failure to Advance; Material Deformation; Break; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE INTERLOCKING ARM WAS DETACHED. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 10MM X 30CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, STC18 MICROCATHETER TOGETHER WITH A NON BOSTON SCIENTIFIC SINGLE CURVE CATHETER WAS USED TO DELIVER THE COIL, HOWEVER IT WAS FELT ABNORMALLY UNSMOOTH, AND THE COIL COULD NO LONGER BE ADVANCED AFTER DELIVERED HALF INTO THE PATIENT'S BODY. IT WAS NOTED THAT THE DELIVERY GUIDEWIRE WAS SEVERELY BENT, AND DURING RECAPTURING, IT WAS NOTED THAT IT COULD NOT BE WITHDRAWN INTO THE PROTECTOR. IT HAD TO BE COMPLETED REMOVED AND THE INTERLOCKING ARM DETACHED. THE PROCEDURE WAS THEN COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18707372 ↗
• InjuryJun 26, 2023Difficult to Remove; Difficult to Advance; Material Integrity Problem; Migration; Difficult to Remove; Difficult to Advance; Material Integrity Problem; Migration

  IT WAS REPORTED THAT COIL MIGRATION OCCURRED AND WAS REMOVED BY GUIDEWIRE. A 10MM X 30CM INTERLOCK WAS SELECTED FOR USE IN A SPLENIC ARTERY ANEURYSM. DURING THE PROCEDURE, WHEN THE COIL WAS ADVANCED WITH THE STC18 MICROCATHETER, SOMETHING WRONG WAS FOUND IN THE PROCESS OF DELIVERY. IT WAS VERY DRY AND NOT SMOOTH. WHEN THE COIL HAS BEEN ADVANCED HALFWAY INSIDE THE PATIENT, IT WAS FOUND THAT THE MICROCATHETER MOVED TO ANOTHER POSITION. DURING WITHDRAWAL, IT WAS FOUND THAT IT COULD NOT BE WITHDRAWN TO THE SHEATH. ALL THE COILS HAD TO BE WITHDRAWN, WHICH FELL OFF. THE COIL WAS JUST COULD NOT FULLY RETRACT, NOT BROKEN. THE COIL WAS REMOVED BY THE GUIDEWIRE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17198015 ↗
• MalfunctionFeb 15, 2023Difficult to Remove; Stretched; Failure to Advance; Difficult to Remove; Stretched; Failure to Advance

  REPORTABLE BASED ON DEVICE INVESTIGATIONS COMPLETED ON 20JAN2023. IT WAS REPORTED THAT THE COIL WAS STUCK IN THE CATHETER. A 10MM X 30CM PE F-IDC INTERLOCK WAS SELECTED FOR USE IN THE EMBOLIZATION OF A SPLENIC ANEURYSM. DURING THE PROCEDURE WHEN THIS DEVICE WAS DEPLOYED, IT WAS NOTED THAT THE COIL COULD NOT BE ADVANCED IN 1/3 OF THE DEPLOYING PROCESS. THE PHYSICIAN TRIED FOR SEVERAL TIMES TO ADVANCE THE COIL SLOWLY BUT FAILED. IN ADDITION, THE COIL COULD NOT BE WITHDRAWN. THE DEVICE WAS SLOWLY WITHDRAWN TOGETHER WITH THE MICROCATHETER. AFTER THE PROCEDURE, THE COIL AND THE MICROCATHETER WERE CHECKED, WHICH REVEALED THAT THE COIL HAD BEEN STUCK IN THE MIDDLE OF THE CATHETER. LATER, THE COIL WAS TAKEN OUT, WHICH WAS FOUND TO BE STRETCHED. THERE WERE NO PATIENT COMPLICATIONS REPORTED, AND THE PATIENT IS STABLE. HOWEVER, DEVICE INVESTIGATIONS REVEALED THAT THE INTERLOCKING ARM OF THE MAIN COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16380481 ↗
• MalfunctionOct 24, 2022Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30SEP2022. IT WAS REPORTED THAT THE DEVICE COULD NOT ADVANCE INSIDE THE CATHETER. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC VESSEL. A 10MM X 30CM INTERLOCK COIL WAS SELECTED FOR USE. DURING PREPARATION, THE COIL WAS STUCK IN THE MIDDLE AND COULD NOT ADVANCE INSIDE THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE PUSHER WIRE GOT DETACHED FROM THE DISTAL SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15663116 ↗
• MalfunctionSep 20, 2022Entrapment of Device; Premature Activation; Entrapment of Device; Premature Activation

  IT WAS REPORTED THAT COIL PROTRUSION OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS ARTERY. A 12MM X 30CM AND 10MM X 30CM INTERLOCK COIL WAS SELECTED FOR USE ACCORDINGLY. DURING THE PROCEDURE, THE MAIN COIL AND THE ARM OF THE DELIVERY WIRE WERE SEPARATED DISTALLY FROM THE CATHETER. FLUSHING WAS PERFORMED INTERMITTENTLY PRIOR TO REMOVING THE DEVICE. SUBSEQUENTLY, IT WAS NOTED THAT THE COIL PROTRUDED FROM THE CATHETER TIP. THE COIL WAS REMOVED TOGETHER WITH THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15459165 ↗
• InjuryJun 6, 2022Break; Difficult to Insert; Premature Activation; Failure to Advance; Break; Difficult to Insert; Premature Activation; Failure to Advance

  IT WAS REPORTED THAT THE COIL PREMATURELY DEPLOYED AND BROKE. AN INTERLOCK 18 10MM X 30CM COIL WAS SELECTED FOR USE IN THE EMBOLIZATION OF TWO CORONARY ANEURYSMS IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD) IN MODERATELY TORTUOUS ANATOMY. A GUIDE CATHETER WAS USED TO REACH THE LAD, AND A DIREXION MICROCATHETER WAS THEN USED TO ATTEMPT ACCESS MORE SELECTIVELY, BUT IT WAS NOT SUCCESSFUL. THEREFORE, A NON-BOSTON SCIENTIFIC MICROCATHETER WAS USED TO REACH THE LOCATION OF THE ANEURYSMS. GAINING ACCESS WAS DIFFICULT AND TOOK APPROXIMATELY TWO HOURS. ONCE REACHED, THE PHYSICIAN DECIDED THEY DID NOT WANT TO LOSE MICROCATHETER POSITION TO EXCHANGE FOR DIREXION. THE INTERLOCK COIL WAS INSERTED INTO THE NON-BOSTON SCIENTIFIC MICROCATHETER, WHICH RESULTED IN SOME RESISTANCE WHEN THE INTERLOCKING ARMS PASSED THROUGH THE HUB OF THE CATHETER. THE COIL WAS FORCED THROUGH, PAST THE POINT OF RESISTANCE. THE COIL TRACKED SMOOTHLY THROUGH THE MICROCATHETER AND WAS POSITIONED WITHIN THE ANEURYSM. UPON DEPLOYMENT, THE FIRST 25CM OF THE COIL DEPLOYED SUCCESSFULLY WITHIN THE ANEURYSM, HOWEVER THE LAST PORTION FAILED TO DEPLOY, AND WHEN THE COIL WAS RETRACTED TO RETRIEVE IT INTO THE MICROCATHETER, IT WAS N

  Patient problems: Foreign Body In Patient; Hematoma; Thrombosis/Thrombus; Vascular Dissection

  MAUDE report 14606655 ↗
• MalfunctionFeb 21, 2022Difficult to Insert; Failure to Advance; Difficult to Insert; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02FEB2022. IT WAS REPORTED THAT THE INTERLOCKING ARM PART DID NOT COME OUT FROM THE TIP OF THE HOOP AND THE INTERLOCK COULD NOT BE ADVANCED WITHIN THE MICROCATHETER. A 10MM X 30CM INTERLOCK COIL WAS SELECTED FOR USE. THE DEVICE WAS HYDRATED INTERMITTENTLY. HOWEVER, DURING THE PROCEDURE, PART OF THE COIL COMES OUT OF THE HOOP, BUT THE LOCKING ARM PART DID NOT COME OUT FROM THE TIP OF THE HOOP. FURTHERMORE, THE INTERLOCK COULD NOT BE ADVANCED WITHIN THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13573088 ↗
• MalfunctionOct 19, 2021Break; Difficult to Remove; Physical Resistance/Sticking; Break; Difficult to Remove; Physical Resistance/Sticking

  IT WAS REPORTED THAT COIL BREAK OCCURRED. A 10MMX50CM 2D INTERLOCK COIL WAS SELECTED FOR USE ON THE EMBOLIZATION OF HEPATIC ARTERY ANEURYSM. DURING THE PROCEDURE, RESISTANCE WAS FELT WHEN THE PHYSICIAN TRIED TO REMOVE THE COIL FROM THE MICROCATHETER. THE RESISTANCE DURING WITHDRAWAL INCREASED, AND AFTER FORCEFULLY PULLING OUT THE COIL FROM THE MICROCATHETER, THE COIL BROKE WITHIN THE MICROCATHETER. THE DEVICE WAS FULLY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12662525 ↗
• MalfunctionSep 9, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED 19AUG2021. IT WAS REPORTED THAT COIL FRICTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE SPLEEN ARTERY ANEURYSM. A 10MM X 30CM 2D INTERLOCK COIL WAS SELECTED WAS USE. DURING THE PROCEDURE, THE COIL COULD NOT BE INSERTED INTO THE NON-BOSTON SCIENTIFIC MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS FINE POST PROCEDURE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED COIL DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12451010 ↗
• MalfunctionJul 1, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER'S TIP DURING REMOVAL. THE NON STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON CALCIFIED INTERNAL ILIAC ARTERY. A 10MMX30CM AND A 10MMX50CM INTERLOCK COIL WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL BECAME STUCK IN THE DISTAL PART OF THE CATHETER. FURTHERMORE, WHEN THE COILS WERE REMOVED FROM THE PATIENT'S BODY, IT WAS NOTED THAT THE DEVICES PROTRUDED FROM THE TIP OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12100977 ↗
• MalfunctionMar 23, 2021Entrapment of Device; Material Twisted/Bent; Entrapment of Device; Material Twisted/Bent

  IT WAS REPORTED THAT THE COILS PROTRUDED IN THE CATHETER'S TIP DURING REMOVAL. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED INTERNAL ILIAC ARTERY. TWO 10MMX30CM 2D INTERLOCK COILS WERE SELECTED FOR USE. DURING THE PROCEDURE, THE FIRST COIL PREMATURELY DETACHED WITHIN THE DELIVERY CATHETER WITH THE COIL PARTIALLY OUT OF THE DELIVERY CATHETER. DURING WITHDRAWAL OF THE SECOND COIL IT BECAME STUCK WITHIN THE DISTAL PART OF THE DELIVERY CATHETER. THE TWO COILS BECAME ENTANGLED WITH EACH OTHER WITHIN THE DELIVERY CATHETER. DURING REMOVAL OF THE DELIVERY CATHETER BOTH COILS PROTRUDED FROM THE CATHETER TIP WHEN REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11553984 ↗
• MalfunctionMar 23, 2021Entrapment of Device; Premature Activation; Entrapment of Device; Premature Activation

  IT WAS REPORTED THAT THE COILS PROTRUDED IN THE CATHETER'S TIP DURING REMOVAL. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED INTERNAL ILIAC ARTERY. TWO 10MMX30CM 2D INTERLOCK COILS WERE SELECTED FOR USE. DURING THE PROCEDURE, THE FIRST COIL PREMATURELY DETACHED WITHIN THE DELIVERY CATHETER WITH THE COIL PARTIALLY OUT OF THE DELIVERY CATHETER. DURING WITHDRAWAL OF THE SECOND COIL IT BECAME STUCK WITHIN THE DISTAL PART OF THE DELIVERY CATHETER. THE TWO COILS BECAME ENTANGLED WITH EACH OTHER WITHIN THE DELIVERY CATHETER. DURING REMOVAL OF THE DELIVERY CATHETER BOTH COILS PROTRUDED FROM THE CATHETER TIP WHEN REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11553945 ↗
• MalfunctionFeb 25, 2021Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09FEB2021. IT WAS REPORTED THAT THE COIL WAS STRETCHED. THE TARGET LESION WAS LOCATED IN THE GASTRIC VEIN. A 10MMX30CM 2D INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN FOUND THE COIL COULD NOT BE ADVANCED. THE PHYSICIAN TRIED SEVERAL TIMES, BUT THE COIL WAS STRETCHED. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED INTERLOCKING ARM DETACHMENT AND FIBER LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11382250 ↗
• MalfunctionJan 4, 2021Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17DEC2020. IT WAS REPORTED THAT THE SPRING COIL WAS STUCK. THE TARGET LESION WAS LOCATED IN THE FEMORAL ARTERY. A 10MM X 30CM F-IDC INTERLOCK COIL WAS SELECTED FOR USE. DURING DEPLOYMENT, IT WAS NOTED THAT THE SPRING COIL STUCK AND COULD NOT BE USED AFTER SEVERAL ATTEMPTS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE PUSHER WIRE DISTAL PART WAS DETACHED AND NOT RETURNED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11111918 ↗
• InjuryJun 16, 2020Break; Separation Failure; Migration; Break; Separation Failure; Migration

  IT WAS REPORTED THAT THE COIL DETACHED, MIGRATED AND REMAINED IN THE PERIPHERAL INTERNAL ILIAC ARTERY. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED RENAL ARTERY. A 10 MM X30 CM INTERLOCK COIL WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE COIL WAS UNABLE TO BE DEPLOYED FROM THE MICROCATHETER. WHEN THE PHYSICIAN TRIED TO REMOVE THE DEVICE TOGETHER WITH THE MICROCATHETER, THE COIL BECAME DETACHED AND FLOWED OFF TO THE PERIPHERAL INTERNAL ILIAC ARTERY. THE COIL WAS NOT RETRIEVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10158483 ↗
• MalfunctionOct 24, 2019Difficult to Insert; Physical Resistance/Sticking; Difficult to Insert; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28SEP2019. IT WAS REPORTED THAT THE RESISTANCE WAS FELT DURING COIL ADVANCEMENT. A 10MM X 30CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT RESISTENCE WAS FELT WHEN ADVANCING THE COIL TO THE MIDDLE OF THE MICRO CATHETER. ADVANCEMENT WAS CONTINUED; HOWEVER THE MICRO CATHETER MISSED THE LESION DUE TO THE LARGE RESISTANCE. THEN, THE COIL WAS WITHDRAWN TO THE PROTECT SHEATH AND THE COIL WAS PLACED INTO HEPARIN AND THE POSITION OF THE MICRO CATHETER WAS ADJUSTED THROUGH THE MICRO GUIDEWIRE. ANOTHER ATTEMPT WAS MADE TO ADVANCE THE COIL; HOWEVER, IT COULD NOT BE PUSHED. THE COIL WAS THEN PLACED IN HEPARIN AND PULLED FORWARD AND BACKWARD; HOWEVER, THE COIL COULD ONLY BE PULLED BACKWARD BUT IT COULD NOT BE PUSHED FORWARD. FINALLY, PHYSICIAN TRIED TO ADVANCE WITH STRENGTH BUT FAILED BECAUSE THE DELIVERY SHAFT WAS KINKED. THE DEVICE WAS REMOVED WITHIN THE CATHETER ALL TOGETHER FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS AND THE PATIENT'S CONDITION WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE PUSHER WIRE WAS DETACHED. IT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9232929 ↗
• MalfunctionJan 15, 2019Entrapment of Device; Premature Activation; Entrapment of Device; Premature Activation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20-DEC-2018. IT WAS REPORTED THAT THE COIL WAS JAMMED AND DETACHED INSIDE CATHETER. A 10MM/30CM INTERLOCK WAS SELECTED FOR EMBOLIZATION. DURING THE PROCEDURE, THE COIL WAS INITIALLY JAMMED AND THEN DETACHED INSIDE A NON-BSC CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WERE MISSING FIBER BUNDLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8249344 ↗