Interlock™-35 M001363830Recalls & reported problems

Summary

The FDA's MAUDE database contains 98 adverse event reports that list this exact device (DI 08714729795445), received between Jan 25, 2019 and Jun 4, 2026 — classified as 6 injuries, 92 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (37 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 98 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2026Premature Activation; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT THE COIL DIFFICULT TO ADVANCE AND PREMATURE DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ANEURYSM. A 20MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR EMBOLIZATION. HOWEVER, RESISTANCE WAS ENCOUNTERED DURING THE DELIVERY PROCESS OF THE COIL. AFTER REPEATED ATTEMPTS, THE INTERLOCKING ARM DISLODGED. 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 A DETACHED COIL ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25392670 ↗
• MalfunctionMar 13, 2026Difficult to Remove; Stretched; Material Deformation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16FEB2026. IT WAS REPORTED THAT THE COIL MEMORY OCCURRED DUE TO RESISTANCE AND COIL WAS STRETCHED. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A 20MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE IN AN EMBOLIZATION OF SPLENIC ANEURYSM. DURING DEPLOYMENT, IT WAS NOTED THAT IT WAS NOT EASY TO COIL DUE TO RESISTANCE IN THE DISTAL TIP OF THE CATHETER. THE COIL WAS RECAPTURED INTO THE SHEATH; HOWEVER, IT WAS FOUND NOT EASY TO PULL, RESULTING IN THE COIL 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 ARM COIL DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24594658 ↗
• MalfunctionMar 4, 2026Premature Activation; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 03FEB2026. IT WAS REPORTED THAT THE COIL PREMATURELY DEPLOYED AND COULD NOT BE ADVANCED FROM THE CATHETER. A 20MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS UNLOCKED INSIDE THE CATHETER, AND IT COULD NOT BE ADVANCED AFTER MANY ATTEMPTS. 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 THAT THE MAIN COIL WAS DETACHED, BENT AND STRETCHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507830 ↗
• MalfunctionFeb 27, 2026Stretched; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS ON 10FEB2026. IT WAS REPORTED THAT THE COIL COULD NOT ADVANCE IN THE MICROCATHETER. A 20MM X 40CM INTERLOCK?-35 WAS SELECTED FOR USE IN A TRANSLUMINAL ANGIOPLASTY FOR ABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE, IT WAS NOTED THAT ONLY HALF OF THIS COIL COULD BE ADVANCED OUT, THEN COULD NO LONGER BE PUSHED OUT NORMALLY. THE COIL WAS REMOVED FROM THE PATIENT'S BODY TOGETHER WITH THE CATHETER. UPON CHECKING, IT WAS NOTED THAT THE COIL HAD BEEN 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 THAT THE COIL ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24471415 ↗
• InjuryFeb 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED BLOOD FLOW OBSTRUCTION ASSOCIATED WITH VENOUS THROMBOSIS REQUIRING ADDITIONAL INTERVENTION. A 20MM X 40CM INTERLOCK .035 COIL WAS SUCCESSFULLY IMPLANTED ON (B)(6) 2026 TO TREAT PELVIC VARICOSE VEINS. DURING A FOLLOW-UP VISIT ON (B)(6) 2025, THE PATIENT REPORTED SWELLING AND PAIN IN THE LEFT LOWER LIMB, PROMPTING FURTHER EVALUATION. AN ANGIOGRAM REVEALED THAT THE IMPLANTED COIL WAS CAUSING BLOOD FLOW OBSTRUCTION ASSOCIATED WITH VENOUS THROMBOSIS. THERE WERE NO SIGNS OF COIL DISPLACEMENT, AND THE DEVICE REMAINED IN THE CORRECT TARGET LOCATION AT THE TIME THE OBSTRUCTION WAS IDENTIFIED. THROMBOASPIRATION WAS PERFORMED. A SECOND PROCEDURE WAS THEN PERFORMED FOR PERCUTANEOUS COIL REMOVAL AND A NEW THROMBECTOMY PROCEDURE.

  Patient problems: Inflammation; Ischemia; Pain; Swelling/ Edema; Thrombosis/Thrombus

  MAUDE report 24460805 ↗
• MalfunctionDec 17, 2025Nonstandard Device; Failure to Advance; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Nonstandard Device; Failure to Advance; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26NOV2025. IT WAS REPORTED THAT THE MAIN COIL WAS UNABLE TO ADVANCE TO THE CATHETER. DURING A PROCEDURE FOR A GIANT ABDOMINAL AORTIC ANEURYSM, A 20MM X 40CM INTERLOCK CONTROLLABLE COILS WERE USED TO PACK THE TUMOR. THREE 20MM X 40CM INTERLOCK COILS WERE SUCCESSFULLY DEPLOYED WITHOUT ISSUE. HOWEVER, WHEN ATTEMPTING TO DELIVER THE FOURTH COIL TO THE ORIFICE OF THE ANGIOGRAPHY CATHETER, INCREASED RESISTANCE WAS ENCOUNTERED, AND THE DEPLOY ANGLE COULD NOT BE ADJUSTED. DESPITE INTERMITTENT HEPARIN WATER FLUSHING, THE ISSUE PERSISTED. UPON WITHDRAWAL, IT WAS DISCOVERED THAT THE INTERLOCKING ARM OF THE COIL WAS DAMAGED. A NEW COIL OF THE SAME SPECIFICATION WAS PROMPTLY REPLACED AND DEPLOYED SUCCESSFULLY, ALLOWING THE PROCEDURE TO CONTINUE SMOOTHLY. IN TOTAL, FIVE 20MM X 40CM INTERLOCK COILS WERE USED, AND THE PROCEDURE WAS COMPLETED. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE MAIN COIL HAD THE ZAP TIP DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23830000 ↗
• MalfunctionDec 12, 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 19NOV2025. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A 20MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL COULD NOT BE ADVANCED NORMALLY AFTER ENTERING THE CATHETER. THE COIL WAS REMOVED, 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 A DETACHED, BENT AND STRETCHED MAIN COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23791018 ↗
• MalfunctionDec 4, 2025Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10NOV2025. IT WAS REPORTED THAT DEVICE DIFFICULT TO ADVANCE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A 20MM X 40CM 035 INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, A SIGNIFICANT RESISTANCE WAS NOTED UPON DEPLOYMENT OF THE THIRD COIL. ATTEMPTS TO WITHDRAW AND RE-DEPLOY WERE UNSUCCESSFUL, AND 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 23722408 ↗
• MalfunctionNov 12, 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 15OCT2025. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED FROM THE CATHETER. A 20MM X 40CM INTERLOCK COIL WAS SELECTED FOR USE IN AN ILIAC ARTERY ANEURYSM EMBOLIZATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL STRETCHED AND COULD NOT BE DELIVERED 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 IN STABLE CONDITION FOLLOWING THE PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THE ARM OF THE COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536512 ↗
• MalfunctionSep 8, 2025Break; Premature Activation; Separation Failure; Difficult to Advance; Break; Premature Activation; Separation Failure; Difficult to Advance

  IT WAS REPORTED THAT THE COIL BECAME FRACTURED. THE NON-STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED VESSEL. A 20MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR PELVIC VARICEAL EMBOLIZATION. DURING THE PROCEDURE, RESISTANCE WAS NOTED WHILE THE COIL WAS DELIVERED USING A NON-BOSTON SCIENTIFIC CATHETER. ALTHOUGH THE COIL WAS SUCCESSFULLY ADVANCED TO THE TARGET VESSEL, IT FAILED TO RELEASE. UPON WITHDRAWAL, THE COIL WAS RELEASED HALFWAY THROUGH THE CATHETER'S PATH AND FRACTURED AT ITS MID SEGMENT. AS A RESULT, THE CATHETER WAS REMOVED WITH THE COIL INSIDE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER INTERLOCK COIL AND A NEW CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22993668 ↗
• MalfunctionSep 8, 2025Break; Premature Activation; Separation Failure; Difficult to Advance; Break; Premature Activation; Separation Failure; Difficult to Advance

  IT WAS REPORTED THAT THE COIL BECAME FRACTURED. THE NON-STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND NON-CALCIFIED VESSEL. A 20MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR PELVIC VARICEAL EMBOLIZATION. DURING THE PROCEDURE, RESISTANCE WAS NOTED WHILE THE COIL WAS DELIVERED USING A NON-BOSTON SCIENTIFIC CATHETER. ALTHOUGH THE COIL WAS SUCCESSFULLY ADVANCED TO THE TARGET VESSEL, IT FAILED TO RELEASE. UPON WITHDRAWAL, THE COIL WAS RELEASED HALFWAY THROUGH THE CATHETER'S PATH AND FRACTURED AT ITS MID SEGMENT. AS A RESULT, THE CATHETER WAS REMOVED WITH THE COIL INSIDE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER INTERLOCK COIL AND A NEW CATHETER. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22993667 ↗
• MalfunctionAug 19, 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 24JULY2025. IT WAS REPORTED THAT THE COIL UNABLE TO ADVANCE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTA. A NON-BSC CATHETER AND 20MM X 40CM INTERLOCK .035 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL COULD NOT BE PUSHED, AND AFTER SEVERAL ATTEMPTS, THE COIL COULD NOT STILL PUSHED OUT. 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 ARM DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22838936 ↗
• MalfunctionAug 18, 2025Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED 22JUL2025. IT WAS REPORTED THAT THE COIL COULD NOT BE WITHDRAWN FROM THE CATHETER. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTA. A 20MM X 40CM INTERLOCK .035 WAS SELECTED FOR USE. DURING THE PROCEDURE, A NON-BOSTON SCIENTIFIC 5F CATHETER WAS USED FOR THE INTERNAL ILIAC ARTERY EMBOLIZATION. THE FIRST 20 X 40 CONTROLLABLE COIL WAS DEPLOYED WITH POOR POSITIONING AND COULD NOT BE WITHDRAWN. AFTER REMOVING THE CONTRAST CATHETER, A REPLACEMENT COIL WAS SUCCESSFULLY DEPLOYED. SIMILARLY, DURING THE SECOND 20 X 40 COIL DEPLOYMENT, UNLOADING OCCURRED. AFTER WITHDRAWING THE CONTRAST CATHETER, A ANOTHER OF THE SAME COIL WAS SUCCESSFULLY DEPLOYED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A DETACHMENT AT THE COIL ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22829129 ↗
• 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 INTERNAL ILIAC ARTERY ANEURYSM. A 20MM X 40CM INTERLOCK -35 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT WHEN THE COIL WAS PUSHED TO 1/3 OF THE ANGIOGRAPHY CATHETER, IT COULD NOT BE PUSHED FORWARD. WHEN ATTEMPTED TO WITHDRAW THE COIL, IT BECAME STUCK AND COULD NOT BE PULLED BACK. THEREFORE, IT WAS REMOVED WITH THE DELIVERY 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 THAT THE MAIN COIL WAS DETACHED AT THE COIL ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22733638 ↗
• 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 DEVICE ANALYSIS COMPLETED ON 13JUN2025. IT WAS REPORTED THAT THE COIL COULD NOT BE PUSHED. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 20MM X 40CM INTERLOCK-35 COIL WAS ADVANCED THROUGH 5F NON-BOSTON SCIENTIFIC SINGLE-CURVE CATHETER. HOWEVER, THE COIL COULD NOT BE PUSHED OUT FROM THE CATHETER. ANOTHER 20X40 CONTROLLABLE COIL WAS USED AND COMPLETED THE PROCEDURE THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT, AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22469941 ↗
• MalfunctionJun 18, 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 20MAY2025. IT WAS REPORTED THAT THE COIL COULD NOT BE PUSHED FORWARD AND GOT STUCK DURING REMOVAL. THE PATIENT UNDERWENT PROCEDURE FOR INTERNAL ILIAC ANEURYSM AND DISTAL ARTERIAL EMBOLIZATION WITH BSC 35 COILS INSIDE THE SHEATH. A 20MM X 40CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL COULD NOT BE PUSHED FORWARD AND WHEN ATTEMPTED TO WITHDRAW, IT WAS NOTED THAT THE COIL WAS STUCK. THE COIL WAS REMOVED TOGETHER WITH THE DELIVERY SYSTEM. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE ZAP TIP AND THE MAIN COIL WERE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22283929 ↗
• MalfunctionMay 14, 2025Difficult to Insert; Adverse Event Without Identified Device or Use Problem; Difficult to Insert; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15APR2025. IT WAS REPORTED THAT THE COIL BECAME STUCK IN THE HUB PART OF THE CATHETER. THE NON-STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED FALSE LUMEN. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL BECAME STUCK IN THE HUB PART OF THE NON-BOSTON SCIENTIFIC CATHETER. THE COIL WAS REMOVED 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, DEVICE ANALYSIS REVEALED THAT ZAP TIP WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22018239 ↗
• MalfunctionMar 21, 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 24FEB2025. IT WAS REPORTED THAT THE COIL WAS UNABLE TO ADVANCE IN THE CATHETER. THE PATIENT UNDERWENT A TRANSCATHETER SPLENIC ARTERY EMBOLIZATION UNDER LOCAL ANESTHESIA, USING A NON-BOSTON SCIENTIFIC (BSC) ANGIOGRAPHY CATHETER AND 20MM X 40CM INTERLOCK-35. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL BECAME STUCK AFTER DELIVERING PART OF THE COIL TO THE CATHETER. THE COIL WAS WITHDRAWN AS IT COULD NOT BE DELIVERED OUT OF THE CATHETER AFTER MANY ATTEMPTS. THE PROCEDURE WAS COMPLETED WITH 20MM X 40 CM COIL USING THE SAME CATHETER. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21663047 ↗
• MalfunctionMar 14, 2025Difficult to Remove; Stretched; Failure to Advance; Difficult to Remove; Stretched; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14FEB2025. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED NOR WITHDRAWN. A 20MM X 40CM INTERLOCK-35 COIL WAS SELECTED FOR EMBOLIZATION OF AN AORTIC DISSECTION. DURING THE PROCEDURE, A 5F NON-BOSTON SCIENTIFIC CATHETER WAS USED TO DELIVER THE COIL INTO THE TARGET LOCATION. BECAUSE THE BLOOD VESSEL WAS TOO TWISTED, THE COIL COULD NOT MOVE FORWARD. THE PHYSICIAN REPEATEDLY PUSHED IT WITHOUT SUCCESS, YET THE COIL COULD NOT BE ADVANCED EVEN WITH HEPARIN SALINE. THE COIL COULD NOT BE WITHDRAWN EITHER. FINALLY, THE CATHETER WAS WITHDRAWN FROM THE VESSEL TOGETHER WITH THE COIL. AFTER THE COIL WAS WITHDRAWN FROM THE CATHETER, IT WAS NOTED THAT THE COIL WAS STRETCHED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THE ZAP TIP AND THE COIL ARM WERE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21606594 ↗
• MalfunctionMar 13, 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 15FEB2025. IT WAS REPORTED THAT THE DEVICE COULD NOT BE DELIVERED OUT OF THE CATHETER AND STRETCHED. THE TARGET LESION WAS LOCATED IN THE HEPATIC PORTAL VEIN. A 20MM X 40CM INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE COULD NOT BE DELIVERED OUT OF THE NON-BOSTON SCIENTIFIC CATHETER, AND OBVIOUS RESISTANCE WAS FELT WHEN THE DEVICE WAS DELIVERED TO THE MIDDLE OF THE CATHETER. BECAUSE THE DEVICE WAS STUCK IN THE CATHETER, THE PHYSICIAN REMOVED THE DEVICE AND THE CATHETER TOGETHER FROM THE PATIENT'S BODY. CONSEQUENTLY, THE COIL WAS STRETCHED UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE MAIN COIL WAS DETACHED AT THE COIL ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21598548 ↗
• MalfunctionDec 3, 2024Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13NOV2024. IT WAS REPORTED THAT THE COIL COULD NOT BE DELIVERED INTO THE PATIENT'S BODY. A 20MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE IN A PERCUTANEOUS EMBOLIZATION OF HEMANGIOMA. DURING THE PROCEDURE, HEPARIN SALINE WAS MANUALLY PUSHED, AND THE CATHETER WAS DELIVERED INTO THE PATIENT'S BODY. HOWEVER, IT WAS NOTED THAT THE COIL COULD NOT BE DELIVERED. IT WAS WITHDRAWN AND REINSERTED, HOWEVER IT STILL COULD NOT BE DELIVERED. THE CATHETER WAS DISCARDED, 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 THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20834651 ↗
• MalfunctionOct 23, 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 DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT COIL ADVANCING ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE AORTA. A 5F NON-BOSTON SCIENTIFIC CATHETER WAS DELIVERED FOR EMBOLIZATION ALONG WITH THE 20MM X 40CM INTERLOCK-35 COIL. DURING THE PROCEDURE, THE COIL COULD NOT BE PUSHED OUT OF THE CATHETER. THE COIL WAS WITHDRAWN, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED DETACHED ARM COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20517162 ↗
• MalfunctionOct 22, 2024Stretched; Separation Failure; Stretched; Separation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26SEP2024. IT WAS REPORTED THAT THE COIL WAS STRETCHED AND COULD NOT BE RELEASED. THE TARGET LESION WAS LOCATED IN THE LEFT RENAL ARTERY. A 20 MM X 40 CM INTERLOCK .035 COIL WAS SELECTED FOR EMBOLIZATION OF RENAL ANEURYSM. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS STRETCHED AND COULD NOT BE RELEASED AFTER THE COIL WAS REPEATEDLY ADVANCED. 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 THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20509777 ↗
• MalfunctionOct 14, 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 19SEP2024. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCE IN THE LESION. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY ABOUT 2CM IN DIAMETER. A 20MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE FULLY ADVANCED INTO THE TARGET ANEURYSM. MULTIPLE ATTEMPTS WERE MADE TO RECAPTURE AND REDEPLOY THE COIL, BUT IT BECAME STUCK IN THE SINGLE CURVE AND COULD NOT BE FULLY PUSHED OUT TO UNLOCK THE INTERLOCK ARM. EVENTUALLY, THE PROCEDURE WAS COMPLETED USING A BOSTON SCIENTIFIC (BSC) 18 STC MICROCATHETER, ALONG WITH 12MM30CM AND 8MM*20CM BSC COILS. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED MAIN COIL DETACHMENT AT THE COIL ARM AND ZAP TIP SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20444847 ↗
• MalfunctionOct 9, 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 DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT COIL FAILURE TO ADVANCE IN CATHETER OCCURRED. THE PATIENT UNDERWENT AN EMBOLIZATION TREATMENT FOR AN ANEURYSM LOCATED IN THE RENAL ARTERY. A 20MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR THIS PROCEDURE. AN IMAGER II BOSTON SCIENTIFIC CATHETER WAS USED TO REACH THE EMBOLIZATION POSITION, AND A CONTINUOUS SALINE IRRIGATION OF THE COIL WAS PERFORMED USING A SYRINGE. HOWEVER, SIGNIFICANT RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE COIL. AFTER WITHDRAWING THE DELIVERY WIRE, THE COIL WAS PUSHED HALFWAY OUT BUT IT COULD NOT BE PUSHED OUT NORMALLY. 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 THAT THE MAIN COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20409010 ↗