Interlock™-35 M001363590Recalls & reported problems

Summary

The FDA's MAUDE database contains 92 adverse event reports that list this exact device (DI 08714729793014), received between Sep 7, 2018 and Jun 12, 2026 — classified as 3 injuries, 89 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (38 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 92 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 12, 2026Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT DEVICE UNABLE TO ADVANCE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILD TORTUOUS AND MILD CALCIFIED SUBCLAVIANE. A 2D 8MM X 40CM .035 INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK IN THE CATHETER DISTAL PART. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A MAIN COIL DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25492296 ↗
• MalfunctionMay 21, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE CATHETER WAS PUNCTURED BY THIS DEVICE. AN 8MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE IN A VARICOCELE EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE INTERLOCK-35 GUIDE PUSHER PUNCTURED THE 5F NON-BOSTON SCIENTIFIC CATHETER. THE COIL WAS SUCCESSFULLY RELEASED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25248314 ↗
• MalfunctionApr 2, 2026Premature Activation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 9MAR2026. IT WAS REPORTED THAT COIL PREMATURE DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ,MODERATELY TORTUOUS AND MILDLY CALCIFIED LEFT INTERNAL ILIAC ARTERY. A 8MM X 40CM INTERLOCK - 35 WAS SELECTED FOR USE. DURING HE PROCEDURE, THE COIL WIRE WAS SEPARATED IN THE DISTAL PART OF THE CATHETER. THE PROCEDURE WAS COMPLETED USING WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED MAIN COIL DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24766884 ↗
• MalfunctionMar 26, 2026Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 26FEB2026. IT WAS REPORTED THAT THE COIL WAS UNABLE TO ADVANCE IN CATHETER. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS INTERNAL ILIAC ARTERY. AN 8MM X 40CM INTERLOCK - 35 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL BECAME STUCK IN THE DISTAL PORTION OF THE CATHETER AND COULD NOT BE ADVANCED. THE COIL AND CATHETER WERE REMOVED TOGETHER, AND THE PROCEDURE WAS COMPLETED USING WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED MAIN COIL DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24706013 ↗
• MalfunctionMar 26, 2026Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26FEB2026. IT WAS REPORTED THAT COIL WAS STUCK AND COULD NOT BE PUSHED OUT. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ANEURYSM. AN 8MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS STUCK DISTAL PART OF THE MICROCATHETER AND COULD NOT BE PUSHED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED AN ARM COIL DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24701947 ↗
• MalfunctionMar 25, 2026Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26FEB2026. IT WAS REPORTED THAT THE COIL HAD RESISTANCE AND COULD NOT BE DELIVERED. THE TARGET LESION WAS LOCATED IN THE STOMACH FUNDUS. AN 8MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT UPON DELIVERING THE COIL, IT HAD RESISTANCE AND COULD NOT BE DELIVERED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24691840 ↗
• MalfunctionMar 6, 2026Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT UNABLE TO ADVANCE COIL OCCURRED. THE 100% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED INTERNAL ILIAC ARTERY. AN 8 MM X 40 CM INTERLOCK -35 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS STUCK IN THE MIDDLE PART OF THE CATHETER. THE PROCEDURE WAS COMPLETED USING WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A DETACHED MAIN COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24530947 ↗
• MalfunctionDec 5, 2025Nonstandard Device; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Nonstandard Device; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 08NOV2025. IT WAS REPORTED THAT DEVICE UNABLE TO ADVANCE AND WAS DAMAGED OCCURRED. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTIC. AN 8MM X 40CM .035 INTERLOCK WAS SELECTED FOR USE. THE BLOOD VESSELS WERE RELATIVELY TORTUOUS. DURING THE PROCEDURE, WHEN THE SECOND 8 X 40 COIL WAS ALMOST COMPLETELY DELIVERED OUT OF THE NON- BOSTON SCIENTIFIC ANGIOGRAPHY CATHETER TIP, RESISTANCE OCCURRED AND FLUSHING WAS INEFFECTIVE. UPON WITHDRAWAL, IT WAS OBSERVED THAT THE INTERLOCKING ARM OF THE COIL WAS DAMAGED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED AN ARM COIL DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23727737 ↗
• InjuryNov 5, 2025Malposition of Device; Positioning Problem; Migration; Malposition of Device; Positioning Problem; Migration

  IT WAS REPORTED THAT COIL MIGRATION OCCURRED REQUIRING ADDITIONAL INTERVENTION. A NON-STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND NON-CALCIFIED ABDOMINAL AORTA. AN 8MM X 40CM INTERLOCK-35 WAS SELECTED FOR ENDOVASCULAR ANEURYSM REPAIR. DURING THE PROCEDURE, A CATHETER KICKBACK OCCURRED DUE TO SEVERE TORTUOSITY DURING THE CONTRALATERAL APPROACH. CONSEQUENTLY, THE COIL WAS DETACHED PREMATURELY AND UNINTENTIONALLY PLACED IN THE UNINTENDED SITE. THE COIL PROTRUDED INTO THE COMMON ILIAC ARTERY AND WAS SEALED WITH A STENT GRAFT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478108 ↗
• MalfunctionOct 21, 2025Premature Activation; Adverse Event Without Identified Device or Use Problem; Premature Activation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26SEP2025. IT WAS REPORTED THAT THE COIL PREMATURELY DEPLOYED INSIDE THE CATHETER. THE TARGET LESION WAS LOCATED IN THE PORTAL VEIN AND HEPATIC ARTERY. AN 8MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR USE IN THE PERCUTANEOUS SELECTIVE ARTERIOGRAPHY AND ARTERIAL EMBOLIZATION. HOWEVER, WHEN THE COIL WAS DELIVERED HALFWAY THROUGH A 5F CATHETER, THE COIL RELEASED AUTOMATICALLY INSIDE THE CATHETER. AFTER WITHDRAWING THE DELIVERY GUIDE WIRE, MULTIPLE ATTEMPTS WERE MADE TO DELIVER IT WITH A SYRINGE, BUT TO NO AVAIL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A MAIN COIL DETACHMENT AT THE ZAP TIP SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23348127 ↗
• MalfunctionSep 17, 2025Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21AUG2025. IT WAS REPORTED THAT THE COIL COULD NOT BE PUSHED OUT OF THE SHEATH. THE PATIENT PRESENTED WITH SPLENIC ANEURYSM UNDERWENT EMBOLIZATION USING AN 8MM X 40CM INTERLOCK .035 COIL. DURING THE PROCEDURE, THE GUIDE WIRE WAS USED TO GO UP FROM THE RIGHT ILIAC ARTERY PUNCTURE SITE TO THE OPENING OF THE SPLENIC ANEURYSM LESION. AFTER THE GUIDE WIRE WAS IN PLACE, A NON-BOSTON SCIENTIFIC ANGIOGRAPHY CATHETER WAS USED TO REACH THE EMBOLIZATION SITE. HOWEVER, WHEN THE COIL WAS ADVANCED WHILE FLUSHING, THE COIL COULD NOT BE PUSHED OUT OF THE SHEATH. THE PHYSICIAN TRIED SEVERAL TIMES, BUT IT COULD NOT PUSH THE COIL OUT. THE PROCEDURE WAS COMPLETED USING A 0.35 SYSTEM 10MM X 40CM INTERLOCK COIL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23080126 ↗
• MalfunctionAug 26, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT CANCELLED PROCEDURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILD CALCIFIED ABDOMINAL AORTA ENTRY. A 8 MM X 40 CM .035 INTERLOCK 2D WAS USED FOR PROCEDURE. DURING THE PROCEDURE THE, IT WAS NOTED THAT THE COIL WAS STUCK INSIDE THE CATHETER MIDDLE PART. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22895855 ↗
• MalfunctionAug 6, 2025Difficult to Remove; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 08JUL2025. IT WAS REPORTED THAT THE COIL WAS UNABLE TO ADVANCE AND UNABLE TO BE WITHDRAWN FROM THE CATHETER. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTIC ANEURYSM. AN 8MM X 40CM INTERLOCK -35 WAS SELECTED FOR USE. DURING THE PROCEDURE, A 5F SINGLE-BEND CATHETER WAS ADVANCED INTO THE INTERNAL ILIAC ARTERY AND INTO THE CONTROLLABLE COIL OF THE BSC 35 SYSTEM. HOWEVER, DUE TO THE Y-VALVE CONNECTION BEING TOO STUCK, THE COIL COULD NOT MOVE FORWARD. IT WAS PUSHED REPEATED BUT FAILED, ALSO THE HEPARIN WATER COULD NOT BE FLUSHED EITHER. UPON WITHDRAWING, THE COIL COULD NOT BE WITHDRAWN. THEREFORE, THE CATHETER WAS WITHDRAWN FROM THE LUMEN TOGETHER. 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 DETACHED MAIN COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22733625 ↗
• MalfunctionJul 24, 2025Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26JUN2025. IT WAS REPORTED THAT THE COIL WAS STUCK IN THE CATHETER. THE PATIENT HAD ABDOMINAL AORTIC ANEURYSM AND LEFT AND RIGHT INTERNAL ILIAC ARTERY ANEURYSMS. A 2D 8MM X 40CM .035 INTERLOCK WAS USED IN EMBOLIZATION OF THE LEFT AND RIGHT INTERNAL ILIAC ARTERIES. DURING THE PROCEDURE, A GUIDEWIRE WAS USED TO REACH THE LEFT INTERNAL ILIAC ARTERY FROM THE RIGHT PUNCTURE OPENING. AFTER THE GUIDEWIRE WAS PLACED A 5F NON-BOSTON SCIENTIFIC ANGIOGRAPHY CATHETER WAS USED FOR SUPERSELECTION TO REACH THE EMBOLIZATION POSITION. WHEN THE COIL WAS USED, THE COIL COULD NOT BE PUSHED OUT OF THE CATHETER. SEVERAL ATTEMPTS WERE MADE; HOWEVER, THE COIL STILL FAILED TO BE PUSHED OUT. ADDITIONALLY, THE COIL COULD NOT BE WITHDRAWN AND WAS REMOVED TOGETHER WITH THE CATHETER. 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 A COIL BREAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22591529 ↗
• MalfunctionJul 23, 2025Difficult to Remove; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26JUN2025. IT WAS REPORTED THAT COIL WAS UNABLE TO ADVANCE AND UNABLE TO BE WITHDRAWN FROM THE CATHETER. THE PATIENT WAS PRESENTED WITH A LEFT INTERNAL ILIAC ARTERY ANEURYSM. THE TARGET LESION WAS LOCATED IN THE LEFT AND RIGHT INTERNAL ILIAC ARTERIES. AN 8MM X 40CM INTERLOCK?-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, A GUIDEWIRE CROSSED FROM THE RIGHT PUNCTURE SITE TO THE LEFT INTERNAL ILIAC ARTERY AND A NON-BOSTON SCIENTIFIC CONTRAST CATHETER WAS USED FOR SUPER-SELECTIVE CATHETERIZATION TO REACH THE EMBOLIZATION SITE. WHEN DELIVERING THE COIL, IT WAS NOTED THAT THE COIL COULD NOT BE DELIVERED OUT OF THE CANNULA. SEVERAL ATTEMPTS WERE MADE BUT FAILED TO DELIVER THE COIL OUT, NOR COULD IT BE RETRACTED. THE COIL WAS WITHDRAWN WITH THE CATHETER TOGETHER. THE LEFT BRACHIAL ARTERY WAS PUNCTURED, AND ANOTHER 5F125 NON-BOSTON SCIENTIFIC CONTRAST CATHETER WAS USED TO REACH THE EMBOLIZATION SITE. ANOTHER COIL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED DETACHED ZAP TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22579811 ↗
• MalfunctionJul 18, 2025Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN 8MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR AN EMBOLIZATION OF INTERNAL ILIAC ARTERY. DURING THE PROCEDURE, THE COIL ENTERED THE PATIENT'S BODY THROUGH THE CATHETER BUT COULD NOT BE PUSHED NORMALLY. IT COULD NOT BE PUSHED AFTER SEVERAL ATTEMPTS. CONSEQUENTLY, THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543369 ↗
• MalfunctionJul 10, 2025Difficult to Remove; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12JUN2025. IT WAS REPORTED THAT THE COIL BECAME STUCK IN THE CATHETER. AN 8MM X 40CM INTERLOCK? -35 WAS SELECTED FOR VARICOCELE EMBOLIZATION. DURING THE PROCEDURE, THE COIL WAS ADVANCED INTO THE NON-BOSTON SCIENTIFIC CATHETER, HOWEVER RESISTANCE WAS FELT. THE COIL WAS TRIED TO BE REMOVED, BUT THE COIL REMAINED STUCK. THE COIL WAS NOT DEPLOYED AND WAS REMOVED TOGETHER WITH THE CATHETER FROM THE PATIENT'S BODY. THE OUTCOME OF THE PROCEDURE WAS SUCCESSFUL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED ARM COIL DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22472899 ↗
• MalfunctionJul 10, 2025Stretched; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Stretched; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13JUN2025. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED AND WAS STRETCHED. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. AN 8MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR TRANSCATHETER INTERNAL ILIAC ARTERY EMBOLIZATION. DURING THE PROCEDURE, WHEN THE CATHETER WAS ADVANCED, IT WAS FOUND THAT IT COULD NEITHER BE ADVANCED FURTHER NOR PULLED BACK. AN ATTEMPT WAS MADE TO PUSH IT THROUGH BUT FAILED. DUE TO THE TIGHTNESS, PULLING IT BACK CAUSED THE COIL TO STRETCH, AND IT COULD NOT BE USED AGAIN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT STATUS WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE MAIN COIL WAS DETACHED AT THE COIL ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22470777 ↗
• InjuryJun 12, 2025Premature Activation; Device-Device Incompatibility; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Premature Activation; Device-Device Incompatibility; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COIL PENETRATED THE GUIDE CATHETER AND THEN DETACHED EARLY, REQUIRING INTERVENTION. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED IIA INFERIOR GLUTEAL ARTERY. A 8MM X 40CM INTERLOCK-35 COIL WAS SELECTED FOR ABDOMINAL ANEURYSM TREATMENT. DURING THE COIL DELIVERY, THE COIL PENETRATED THE 5F NON-BOSTON SCIENTIFIC GUIDE CATHETER AND THEN DETACHED. THE COIL WAS TEMPORARILY LEFT INSIDE THE BODY AND LATER RECOVERED USING A SNARE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22199083 ↗
• MalfunctionApr 23, 2025Premature Activation; Adverse Event Without Identified Device or Use Problem; Premature Activation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON (B)(6) 2025. IT WAS REPORTED THAT PREMATURE DEPLOYMENT OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. AN 8MMX40CM INTERLOCK EMBOLICS DEVICE WAS SELECTED FOR USE. DURING THE PROCEDURE, THE INITIAL 10X40 INTERLOCK COIL WAS DEPLOYED, BUT ITS POSITION WAS DEEMED UNSATISFACTORY. AN ATTEMPT TO WITHDRAW THE COIL WAS UNSUCCESSFUL INITIALLY, AS IT COULD NOT BE RETRACTED AS INTENDED. THE COIL WAS EVENTUALLY RETRIEVED FROM THE PATIENTS BODY USING THE CATHETER. A SECOND COIL OF THE SAME MODEL WAS THEN SUCCESSFULLY DEPLOYED. DURING THE DEPLOYMENT OF THE THIRD 8X40 INTERLOCK COIL, DETACHMENT OCCURRED; HOWEVER, THE COIL WAS SUCCESSFULLY WITHDRAWN FROM THE PATIENTS BODY USING THE CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE MAIN COIL WAS DETACHED, BENT AND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21890600 ↗
• MalfunctionApr 1, 2025Difficult to Remove; Stretched; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Stretched; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04MAR2025. IT WAS REPORTED THAT THE COIL WAS UNABLE TO BE WITHDRAWN AND BECAME STRETCHED. THE TARGET LESION WAS LOCATED IN THE AORTIC LUMEN. AN 8MM X 40CM INTERLOCK-35 COIL WAS SELECTED FOR ENDOVASCULAR AORTIC GRAFT EXCLUSION. DURING THE PROCEDURE, THE COIL WAS DELIVERED USING A 4F ANGIOGRAPHY CATHETER, AND CONTINUOUS INFUSION OF HEPARIN SALINE WAS SET. HOWEVER, IT WAS NOTED THAT THE COIL WAS UNABLE TO BE WITHDRAWN AND BECAME STRETCHED. THE COIL WAS THE WITHDRAWN OUTSIDE THE BODY, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21739594 ↗
• MalfunctionDec 4, 2024Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 15NOV2024. IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO BE ADVANCED. THIS 8MM X 40CM INTERLOCK-35 DEVICE WAS SELECTED FOR USE IN A STENOSED INTERNAL ILIAC ARTERY. DURING THE PROCEDURE, THE COIL COULD NOT BE SUCCESSFULLY DELIVERED TO THE DISTAL END OF THE NON BOSTON SCIENTIFIC CATHETER DESPITE REPEATED ATTEMPTS. THE COIL WAS REMOVED FROM THE BODY. IT WAS NOTED THAT WHEN RELEASING THE COIL, IT COULD NOT BE PUSHED OUT. THEREFORE, THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20844682 ↗
• MalfunctionNov 22, 2024Stretched; Difficult to Advance; Stretched; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT THE COIL WAS DIFFICULT TO ADVANCE AND WAS STRETCHED. THE PATIENT PRESENTED WITH SPLENIC ANEURYSM AND UNDERWENT EMBOLIZATION. AFTER PLACING THE IMAGING CATHETER, AN 8MM X 40CM INTERLOCK-35 WAS ADVANCED. HOWEVER, IT WAS DIFFICULT TO DELIVER, AND AFTER PUSHING BACK AND FORTH SEVERAL TIMES, IT WAS FOUND THAT THE COIL WAS STRETCHED. THE MICROCATHETER WAS REINSTALLED, AND THEN 4 CONTROLLABLE COILS OF THE .18 SYSTEM WERE USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE COIL WAS DETACHED FROM THE COIL ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20759015 ↗
• MalfunctionSep 12, 2024Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. AN 8MM X 40CM 2D INTERLOCK-35 COIL WAS SELECTED FOR USE IN THE EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN WAS UNABLE TO ADVANCE THE COIL THROUGH AN UNKNOWN 5F CATHETER. THE INTERLOCK-35 WAS REMOVED, AND ANOTHER OF THE SAME DEVICE WAS USED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE COIL ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20206820 ↗
• MalfunctionJun 13, 2024Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24MAY2024. IT WAS REPORTED THAT THE COIL COULD NOT BE DELIVERED INTO THE IMAGING CATHETER. THE TARGET LESION WAS LOCATED IN THE ARTERIA CRURALIS. AN 8MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE DELIVERED INTO THE IMAGING CATHETER. THE DEVICE WAS WITHDRAWN, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19531714 ↗