Interlock™-35 M001363610Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 08714729793168), received between Nov 15, 2018 and Apr 7, 2026 — classified as 3 injuries, 57 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (19 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 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 7, 2026Difficult to Remove; Difficult 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 COIL DIFFICULTY ADVANCEMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC VEIN. A 10MM X 40CM INTERLOCK - 35 WAS SELECTED FOR USE. DURING ADVANCEMENT OF THE SECOND COIL, RESISTANCE WAS ENCOUNTERED, AND THE COIL COULD NOT BE ADVANCED OR WITHDRAWN INDEPENDENTLY. AS A RESULT, THE COIL AND CONTRAST CATHETER WERE WITHDRAWN TOGETHER. THE COIL WAS SUBSEQUENTLY REMOVED OUTSIDE THE PATIENT. THE ANGIOGRAPHY CATHETER WAS THEN REPLACED, AND ANOTHER COIL OF THE SAME TYPE WAS USED. A TOTAL OF TWO 0.035 SYSTEM COILS WERE UTILIZED, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENTS CONDITION FOLLOWING THE PROCEDURE WAS REPORTED AS STABLE. NO COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED ARM COIL DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24802225 ↗
• MalfunctionApr 6, 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 COIL COULD NOT ADVANCE THE MICROCATHETER. THE TARGET LESION WAS LOCATED IN THE GASTRIC CORONARY VEIN. A 10MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE IN A TRANSHEPATIC INTRAJUGULAR PORTOSYSTEMIC SHUNT (TIPS) COMBINED WITH GASTRIC FUNDUS VARICEAL EMBOLISM. DURING THE PROCEDURE, IT WAS NOTED THAT THE INTERLOCK COULD NOT BE PUSHED OUT IN THE CATHETER AFTER MANY ATTEMPTS. THE CATHETER AND COIL WERE WITHDRAWN, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.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 DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792862 ↗
• MalfunctionFeb 18, 2026Premature Activation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06FEB2026. IT WAS REPORTED THAT PREMATURE DEPLOYMENT OCCURRED. A 10MM X 40CM INTERLOCK?-35 WAS SELECTED FOR USE IN A PROCEDURE. DURING THE EVENT, THE INTERLOCK?-35 WAS DAMAGED AND SEPARATED INSIDE OF THE DELIVERY SHEATH, WHICH CAUSED PREMATURE DEPLOYMENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED THROUGH THE GOOD FAITH EFFORT (GFE) PROCESS REGARDING PATIENT CONDITION AND PROCEDURE DETAILS; HOWEVER, NO ADDITIONAL INFORMATION HAS BEEN RECEIVED. HOWEVER, DEVICE ANALYSIS REVEALED THE COIL ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24379743 ↗
• MalfunctionJan 27, 2026Difficult to Remove; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30DEC2025. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED OR WITHDRAWN FROM THE CATHETER. THE TARGET LESION WAS LOCATED IN THE COMMON ILIAC ARTERY. A 10MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR USE IN AN ENDOVASCULAR GRAFT EXCLUSION OF ABDOMINAL AORTA TO TREAT COMMON ILIAC ARTERY ANEURYSM COMBINED WITH INTERNAL ILIAC ARTERY ANEURYSM. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE ADVANCED FROM THE CATHETER AFTER PARTIAL DEPLOYMENT, NOR COULD IT BE WITHDRAWN. THE COIL ALONG WITH THE CATHETER WERE WITHDRAWN FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT STATUS WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A DETACHED INTERLOCKING ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24188937 ↗
• MalfunctionJan 15, 2026Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 19DEC2025. IT WAS REPORTED THAT UNABLE TO ADVANCE IN CATHETER OCCURRED. A 10MM X 40CM INTERLOCK .035 EMBOLICS WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL BECAME STUCK INSIDE THE CATHETER. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24079774 ↗
• MalfunctionJan 15, 2026Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19DEC2025. IT WAS REPORTED THAT THE COIL WAS UNABLE TO ADVANCE IN THE CATHETER. VASCULAR ACCESS WAS VIA RIGHT ILIAC ARTERY. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A 10MM X 40CM INTERLOCK -35 WAS SELECTED FOR SPLENIC ARTERY EMBOLIZATION. DURING THE PROCEDURE, WHILE DELIVERING THE COIL WITH CONTINUOUS FLUSHING, THE PHYSICIAN ENCOUNTERED DIFFICULTY AS THE COIL COULD NOT BE PUSHED OUT OF ITS SLEEVE DESPITE MULTIPLE ATTEMPTS. THERE WERE NO PATIENT COMPLICATION AS THE RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24079773 ↗
• MalfunctionDec 17, 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 24NOV2025. IT WAS REPORTED THAT PREMATURE DEPLOYMENT OCCURRED. A 10MM X 40CM INTERLOCK 35 COIL WAS SELECTED FOR EMBOLIZATION. HOWEVER, IT WAS NOTED THAT THE COIL BECAME DETACHED INSIDE THE MIDDLE PART OF THE 5 FR CATHETER DURING ADVANCEMENT. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23832739 ↗
• MalfunctionOct 21, 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 24SEP2025. IT WAS REPORTED THAT THE COIL COULD NOT BE DELIVERED OUT OF THE SHEATH. A 10MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR USE IN THE ARTERY EMBOLIZATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE DELIVERED OUT OF THE SHEATH. AFTER TAKING OUT THE WHOLE ASSEMBLY, THE COIL WAS STRETCHED. 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 A DETACHED INTERLOCKING ARM, WITH ADDITIONAL BENDING AND STRETCHING OBSERVED IN THE MIDDLE SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23347885 ↗
• MalfunctionJul 10, 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 THE DEVICE ANALYSIS COMPLETED ON (B)(6) 2025. IT WAS REPORTED THAT THE COIL WAS UNABLE TO ADVANCE. THE STENOSED TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A 10MM X 40CM INTERLOCK .035 DEVICE WAS SELECTED FOR USE. DURING THE PROCEDURE, ATTEMPTS WERE MADE TO RELEASE THE COIL, HOWEVER, IT BECAME LODGED AND COULD NOT BE FURTHER ADVANCED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING AN ADDITIONAL DEVICE OF THE SAME TYPE. 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 22472900 ↗
• MalfunctionJul 10, 2025Entrapment of Device; Device-Device Incompatibility; Positioning Problem; Entrapment of Device; Device-Device Incompatibility; Positioning Problem

  IT WAS REPORTED THAT COIL STUCK TO CATHETER TIP. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 10MM X 40CM INTERLOCK.35 COIL WAS SELECTED FOR INTERNAL ILIAC EMBOLIZATION USING AN IPSILATERAL APPROACH. DURING THE PROCEDURE, THE CONTRAST CATHETER BOUNCED BACK DUE TO KICKBACK, CAUSING A HOLE IN THE CONTRAST CATHETER AND CAUSING THE COIL SIDE INTERLOCKING ARM TO GET CAUGHT IN THE HOLE. THEN, THE SHEATH AND THE SYSTEM WERE REMOVED. THE COIL AND THE CATHETER WERE ABLE TO REMOVE WITHOUT ANY PROBLEM AND THERE WERE NO REMAINS INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22469428 ↗
• MalfunctionJul 8, 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 11JUN2025. IT WAS REPORTED THAT THE COIL COULD NOT BE PUSHED OUT. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTA AND LEFT INTERNAL ILIAC ARTERY. A 10MM X 40CM INTERLOCK-35 WAS SELECTED FOR INTERVENTIONAL EMBOLIZATION. DURING THE PROCEDURE, THE GUIDE WIRE WAS USED TO CROSS THE RIGHT PUNCTURE PORT TO THE LEFT INTERNAL ILIAC ARTERY. AFTER THE GUIDE WIRE WAS IN PLACE, THE NON-BOSTON SCIENTIFIC ANGIOGRAPHY CATHETER WAS USED TO REACH THE EMBOLIZATION POSITION. HOWEVER, WHEN THE COIL WAS PUSHED NORMALLY, THE COIL COULD NOT BE PUSHED OUT OF THE OUTER SHEATH. THE PHYSICIAN TRIED SEVERAL TIMES BUT COULD NOT PUSH THE COIL OUT. 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 THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437241 ↗
• MalfunctionDec 13, 2024Stretched; Adverse Event Without Identified Device or Use Problem; Stretched; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27NOV2024. IT WAS REPORTED THAT THE COIL WAS UNRAVELED. THE PATIENT WAS UNDERGOING A STENT GRAFT INSERTION PROCEDURE FOR TREATMENT OF AN ABDOMINAL ANEURYSM. THE TARGET LOCATION WAS IN THE MODERATELY TORTUOUS RIGHT INTERNAL ILIAC ARTERY. A 10MM X 40CM INTERLOCK-35 COIL WAS SELECTED. HOWEVER, DURING THE PROCEDURE IT WAS NOTED THAT THE COIL WAS UNRAVELED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT INJURY WAS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THE COIL ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20926167 ↗
• MalfunctionNov 15, 2024Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 23OCT2024. THE PATIENT UNDERWENT TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) COMBINED WITH EMBOLIZATION IN THE GASTRIC FUNDUS VEIN. A 10MM X 40CM INTERLOCK .035 COIL WAS SELECTED TOGETHER WITH A NON-BOSTON SCIENTIFIC (BSC) ANGIOGRAPHY CATHETER. DURING THE PROCEDURE, THE COIL COULD NOT ADVANCE FORWARD DESPITE SEVERAL ATTEMPTS MADE. AFTER WITHDRAWING AND CONTINUOUSLY PUSHING IT, IT COULD NOT BE PUSHED. AFTER THE COIL WAS REMOVED, IT WAS FOUND THAT THE COIL HAD ALREADY DEPLOYED IN THE CATHETER. THE PROCEDURE WAS COMPLETED WITH AN 8MM X 20CM INTERLOCK COIL. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE ARM OF THE COIL DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20698981 ↗
• MalfunctionJun 14, 2024Break; Break

  IT WAS REPORTED THAT THE END OF THE COIL HAD NO INTERLOCKING ARM. THE TARGET LOCATION WAS IN THE LEFT INTERNAL ILIAC ARTERY. A 10MM X 40CM INTERLOCK-35 WAS THE FIRST COIL ADVANCED FOR EMBOLIZATION OF THE ILIAC ANEURYSM. DURING THE PROCEDURE, THE COIL WAS DETACHED WHILE IT WAS BEING ADVANCED, AND IT WAS OBSERVED THAT THE END OF THE COIL HAD NO INTERLOCKING ARMS. A SECOND COIL, A 12MM X 40CM INTERLOCK-35 WAS ATTEMPTED TO BE USED, BUT IT COULD NOT BE PUSHED OUT OF THE TIP OF THE PROTECTIVE SHEATH EVEN AFTER MULTIPLE ATTEMPTS. THE COIL WAS FOUND TO BE STRETCHED. SUBSEQUENTLY, AN 8MM X 40MM COIL WAS USED AND ADVANCED SUCCESSFULLY. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19540893 ↗
• MalfunctionApr 3, 2024Stretched; 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 (B)(6) 2024. IT WAS REPORTED THAT THE COIL COULD NOT BE PUSHED OUT, AND THE COIL WAS STRETCHED. A 10MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR SPLENIC ANEURYSM EMBOLIZATION. THE PROCEDURE PLAN WAS TO OUTFLOW TRACT EMBOLIZATION, INFLOW TRACT EMBOLIZATION AND TUMOR CAVITY EMBOLIZATION, TUMOR WAS 2.4CM. THE MICROCATHETER WAS SUPERSELECTED TO OUTFLOW TRACT TO EMBOLIZE THREE TUMORS, AND THEN THE COIL WAS USED TO EMBOLIZE THE TUMOR. HOWEVER, WHEN THE COIL WAS DEPLOYED, IT WAS FOUND THAT IT COULD NOT BE PUSHED OUT, THE COIL WAS STRETCHED AFTER THE BACK-AND-FORTH OPERATION. 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 A MAIN COIL DETACHMENT AT THE COIL ARM AND PRIMARY COIL SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19036368 ↗
• MalfunctionFeb 28, 2024Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05FEB2024. IT WAS REPORTED THAT THE COIL COULD NOT CROSS THE ANGLED PART OF THE CATHETER. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 10MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT CROSS THE ANGLED PART OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, IT WAS REVEALED THAT THE MAIL COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18796915 ↗
• MalfunctionDec 21, 2023Difficult to Insert; Difficult to Insert

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18DEC2023. IT WAS REPORTED THAT THE COIL COULD NOT BE INSERTED INTO THE CATHETER. A 10MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE FOR EMBOLIZATION OF AN OVARIAN VEIN. INTERMITTENT FLUSHING OF THE INTERLOCK-35 COIL WAS PERFORMED. WHILE INSERTING THE INTERLOCK-35 COIL INTO A NON-BSC CATHETER, RESISTANCE WAS NOTED AT THE PROXIMAL END OF THE CATHETER. THE INTERLOCK-35 COIL WAS WITHDRAWN AND REMOVED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE, SAME MODEL. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE MAIN COIL WAS DETACHED AT THE COIL ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18376949 ↗
• MalfunctionOct 6, 2023Difficult to Remove; Stretched; Failure to Advance; Difficult to Remove; Stretched; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12SEP2023. IT WAS REPORTED THAT THE INTERLOCKING ARM WAS STUCK ON THE CATHETER AND THE COIL HAD BEEN STRETCHED. THE TARGET LESION WAS IN THE INTERNAL ILIAC ARTERY. A 2D 10MM X 40CM INTERLOCK .035 WAS SELECTED FOR USE. DURING THE EMBOLIZATION OF INTERNAL ILIAC ARTERY, DUE TO THE ADJUSTMENT OF SHAPE AND POSITION, THE DEVICE WAS RE-DEPLOYED AFTER WITHDRAWAL. HOWEVER, THE INTERLOCKING ARM WAS STUCK IN THE MIDDLE OF THE CATHETER, WHICH COULD NEITHER GO FORWARD NOR BACKWARD. THE DEVICE WAS PULLED OUT AND IT WAS FOUND THAT THE COIL HAD BEEN STRETCHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE. HOWEVER, DEVICE INVESTIGATIONS REVEALED THAT THE MAIN COIL WAS DETACHED AT THE COIL ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17889867 ↗
• MalfunctionSep 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09AUG2023. A 10MM X 40CM .035 INTERLOCK 2D COIL WAS RECEIVED WITH NO ISSUES REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A DETACHED COIL AT THE INTERLOCKING ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17691200 ↗
• MalfunctionAug 25, 2023Stretched; Failure to Advance; Stretched; Failure to Advance

  REPORTABLE BASED ON DEVICE INVESTIGATION COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT THE COIL GOT STUCK. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 10MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS STUCK IN THE MIDDLE OF THE CATHETER AND WAS STRETCHED AFTER WITHDRAWAL. THE DEVICE WAS SIMPLY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME COIL. NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE MAIN COIL WAS DETACHED AT THE COIL ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17623236 ↗
• MalfunctionAug 8, 2023Entrapment of Device; Failure to Advance; Material Integrity Problem; Entrapment of Device; Failure to Advance; Material Integrity Problem

  IT WAS REPORTED THAT THE COIL PROTRUDED IN THE CATHETER'S TIP UPON REMOVAL. A 10MM X 40CM AND 15MM X 40CM INTERLOCK-35 COILS WERE SELECTED FOR VENTRAL AORTA BRANCH COVERED STENT IMPLANTATION, LEFT AND RIGHT INTERNAL ILIAC ARTERY EMBOLIZATION, AND AORTOGRAPHY. DURING THE PROCEDURE, A 15MMX40CM COIL WAS PUSHED TO THE NECK OF THE MAIN ABDOMINAL TUMOR, BUT IT COULD NOT BE FURTHER ADVANCED, WHICH COULD GO BACK BUT NOT FORWARD. EMBOLIZATION COULD NOT BE COMPLETED WITH THE INTERNAL ILIAC ARTERY, SO A 10MMX40CM WAS USED TO SUPERSELECT THE RIGHT ILIAC THROUGH THE LEFT FEMORAL ARTERY. HOWEVER, THE FIRST 10CM WERE SMOOTH, BUT THE POSITION WAS NOT SUITABLE AND COULD NOT BE ADVANCED AFTER MULTIPLE ATTEMPTS. FURTHERMORE, WHEN THE COILS WERE REMOVED FROM THE PATIENT'S BODY, IT WAS NOTED THAT THE COILS PROTRUDED FROM THE TIP OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17480786 ↗
• MalfunctionMar 23, 2023Break; Separation Failure; Break; Separation Failure

  IT WAS REPORTED THAT THE PUSHER WIRE BROKE. A .035 INTERLOCK 2D 10MM X 40CM WAS SELECTED FOR USE IN A PELVIC VEIN EMBOLIZATION PROCEDURE. DURING STANDARD DEPLOYMENT OF THE COIL INTO THE TARGET LOCATION, IT WAS OBSERVED THAT THE PUSHER WIRE WAS FLOPPY DUE TO A BROKEN CORE WIRE. THE COIL WAS ABLE TO BE DEPLOYED AND THE PUSHER WIRE WAS RETRIEVED. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16607576 ↗
• MalfunctionJan 13, 2023Difficult to Remove; Stretched; Failure to Advance; Difficult to Remove; Stretched; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT THE COIL GOT STUCK AND STRETCHED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS ILIAC ARTERY. A 10MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK IN THE DISTAL PART OF THE CATHETER. WHEN IT WAS PULLED ONCE, RESISTANCE WAS FELT, AND THE COIL GOT UNRAVELED. THE COIL WAS REMOVED TOGETHER WITH THE CATHETER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16163895 ↗
• MalfunctionDec 20, 2022Stretched; 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 29NOV2022. IT WAS REPORTED THAT THE COIL COULD NOT ADVANCED. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MILDLY CALCIFIED LEFT ILIAC ARTERIOVENOUS. A 10MM X 40CM INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL COULD NOT BE PUSHED THROUGH IN THE MIDDLE PART OF A 5F NON-BOSTON SCIENTIFIC CATHETER. AFTER SEVERAL ATTEMPTS, THE DEVICE WAS FOUND STRETCHED. THE COIL WAS REMOVED DIRECTLY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE INTERLOCKING ARM WAS FOUND DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16018617 ↗
• MalfunctionDec 2, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14NOV2022. IT WAS REPORTED THAT THE COIL WAS STUCK IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE SPLEEN. A 10MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE FIRST DEPLOY LOCATION WAS NOT SATISFIED, AND THE COIL WAS STUCK IN THE CATHETER AND COULD NOT BE PUSHED OUT AND COULD NOT BE PULLED BACK. THE PHYSICIAN TRIED SEVERAL TIMES BUT STILL COULD NOT PUSH THE COIL, DURING WHICH SALINE IRRIGATION AND OTHER METHODS COULD NOT BE PUSHED. THE ENTIRE CATHETER WAS REMOVED 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 INTERLOCKING ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15908947 ↗