Interlock™-35 M001363800Recalls & reported problems

Summary

The FDA's MAUDE database contains 86 adverse event reports that list this exact device (DI 08714729795513), received between Sep 26, 2018 and May 28, 2026 — classified as 4 injuries, 82 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (35 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 86 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 28, 2026Premature Activation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT PREMATURE DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTA. A 10MM X 40CM INTERLOCK .035 WAS SELECTED FOR USE. DURING THE DELIVERY PROCESS, THE COIL WAS FOUND TO BE DISLODGED, AND THE WHOLE CONTRAST CATHETER WAS WITHDRAWN FROM THE BODY. 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 THE COIL ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25322701 ↗
• MalfunctionMay 27, 2026Stretched; Failure 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 COULD NOT BE ADVANCED FROM THE CATHETER AND WAS STRETCHED. A 10MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR USE IN THE INTERNAL ILIAC ARTERY. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE PUSHED OUT THE ANGIOGRAPHY CATHETER. THE COIL WAS WITHDRAWN AND IT WAS FOUND THE COIL WAS STRETCHED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A DETACHED INTERLOCKING ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25308375 ↗
• MalfunctionMay 18, 2026Nonstandard Device; Separation Failure; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT THE COIL COULD NOT BE DEPLOYED. A 10MM X 40CM INTERLOCK .035 OIL WAS SELECTED FOR LEFT SUBCLAVIAN ARTERY EMBOLIZATION. A NON-BOSTON SCIENTIFIC DELIVERY COIL WAS USED AND CONTINUOUS FLUSHING WITH HEPARINIZED SALINE WAS PERFORMED THROUGHOUT THE PROCEDURE. FLUSHING WAS DONE BEFORE INTRODUCING THE COIL. AFTER THE COIL WAS ADVANCED INTO POSITION, IT WAS FOUND THAT THE COIL AND THE INTERLOCKING ARM COULD NOT BE DETACHED. MULTIPLE ATTEMPTS WERE UNSUCCESSFUL, SO THE COIL WAS WITHDRAWN FROM THE BODY. IT WAS DISCOVERED THAT THE INTERLOCKING ARMS COULD NOT BE RE-FASTENED. 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 THE CORE WIRE OF THE DELIVERY WIRE WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25201508 ↗
• MalfunctionApr 17, 2026Entrapment of Device; Stretched; Failure to Advance

  IT WAS REPORTED THAT THE COIL BECAME STUCK WITH THE CATHETER TIP. THE PATIENT PRESENTED WITH A SPLENIC ANEURYSM AND UNDERWENT EMBOLIZATION WITH A 10 MM X 40 CM INTERLOCK .035 COIL. THE COIL DELIVERY WAS PERFORMED USING A NON-BOSTON SCIENTIFIC CONTRAST CATHETER. HOWEVER, DURING DEPLOYMENT, THE COIL COULD NOT BE FULLY ADVANCED IN THE NON-BOSTON SCIENTIFIC CONTRAST CATHETER. BOTH THE COIL AND CATHETER WERE WITHDRAWN OUT OF THE BODY. UPON INSPECTION, IT WAS NOTED THAT THE TAIL END OF THE COIL WAS STRETCHED AND PROTRUDING FROM THE CATHETER'S TIP. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24911333 ↗
• MalfunctionMar 17, 2026Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 18FEB2026 IT WAS REPORTED THAT THE COIL WAS UNABLE TO ADVANCE IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 10MM X 40CM INTERLOCK - 35 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS ADVANCED INTO THE CATHETER, IT TIRED MANY TIMES BUT IT STILL COULD NOT BE ADVANCED INTO THE CATHETER. THE PROCEDURE WAS COMPLETED BY REPLACING WITH ANOTHER OF THE SAME COIL. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A MAIN COIL DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24620073 ↗
• MalfunctionFeb 16, 2026Premature Activation; Difficult to Remove; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19JAN2026. IT WAS REPORTED THAT COIL WAS UNABLE TO BE WITHDRAWN FROM THE CATHETER AND WAS PREMATURELY DETACHED. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTA AND LEFT COMMON ILIAC ARTERY. A 10MM X 40CM INTERLOCK 35 WAS SELECTED FOR USE. DURING THE PROCEDURE, THERE WAS NO RESISTANCE TO DELIVERING IN THE CATHETER. WHEN THE PUSHING ROD WAS DELIVERED AT ONE THIRD, THERE WAS RESISTANCE. THE COIL STILL COULD NOT BE DELIVERED AFTER SEVERAL ATTEMPTS, AND THEN IT WAS FOUND THAT IT HAD BEEN DETACHED IN THE CATHETER. THEN THE PHYSICIAN OPENED ANOTHER COIL, AND THERE WAS NO RESISTANCE TO DELIVERING IN THE CATHETER. AFTER REACHING THE EMBOLIZATION POSITION, THE TIP END WAS COILED UP NORMALLY. HOWEVER, SINCE THE EMBOLIZATION POSITION WAS NOT IDEAL, THE COIL WAS ATTEMPTED TO BE REMOVED, BUT IT WAS FOUND THAT IT COULD NOT BE WITHDRAWN AND DELIVERED. ONE HALF OF THE COIL WAS IN THE CATHETER LUMEN. AFTER WITHDRAWAL, IT WAS FOUND THAT THE COIL HAD BEEN DETACHED. 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, DEVI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24344998 ↗
• MalfunctionJan 14, 2026Difficult to Remove; Stretched; Material Deformation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17DEC2025. IT WAS REPORTED THAT THE COIL COULD NOT BE COILED UP, STRETCHED, AND WAS NOT EASY TO PULL. A 10MM X 40CM INTERLOCK .035 WAS SELECTED FOR EMBOLIZATION OF ARTERIOVENOUS FISTULA OF UPPER LIMB. HOWEVER, DURING DEPLOYMENT, IT WAS NOTED THAT THE COIL COULD NOT BE COILED UP BECAUSE OF THE EMBOLIZATION POSITION. WHEN THE COIL WAS RECAPTURED INTO THE SHEATH, IT WAS FOUND THAT IT WAS NOT EASY TO PULL, AND THEN THE COIL WAS STRETCHED. THE ANGIOGRAPHY CATHETER WAS WITHDRAWN 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, DEVICE ANALYSIS REVEALED THAT THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24068077 ↗
• InjuryDec 18, 2025Stretched; Stretched

  IT WAS REPORTED THAT THE COIL WAS STRETCHED, REQUIRING INTERVENTION. A 10MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS STRETCHED. A SNARE WAS USED TO REMOVE THE COIL FROM THE PATIENT'S BODY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE TARGET LESION WAS LOCATED IN THE HEPATIC VESSEL. A PART OF THE COIL WAS REMOVED. HOWEVER, IT WAS ABLE TO BE PUSHED BACK IN, AND THE COIL REMAINED INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838887 ↗
• MalfunctionAug 15, 2025Premature Activation; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Premature Activation; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22JUL2025. IT WAS REPORTED THAT ADVANCING ISSUE AND EARLY DETACHMENT OCCURRED. A 10MM X 40CM INTERLOCK? -35 WAS SELECTED FOR EMBOLIZATION OF GASTRIC FUNDUS. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE PUSHED OUT OF THE 5F ANGIOGRAPHY CATHETER ALL THE TIME, AND IT WAS DETACHED BY ITSELF IN THE PROTECTIVE SHEATH. AFTER IT WAS REMOVED FROM THE PATIENT, 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 COIL ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816649 ↗
• 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 COULD NOT BE SENT OUT IN THE DELIVERY SHEATH. THE STENOSED TARGET LESION WAS LOCATED IN THE LOWER EXTREMITY ILIAC ARTERY. THE PATIENT UNDERWENT EMBOLIZATION OF A LEFT SAGITTAL ANEURYSM WITH A DISSECTING COMPONENT. USING THE EXTENSION TUBE, A 35 CONTROLLABLE COIL WAS DEPLOYED INTO THE HEMANGIOMA OF THE AFFECTED AREA THROUGH A PERCUTANEOUS PUNCTURE PROCEDURE. DURING DEPLOYMENT, THE COIL FAILED TO DEPLOY FROM THE DELIVERY SHEATH AND COULD ONLY BE WITHDRAWN. IT WAS UNABLE TO ADVANCE FORWARD THROUGH THE CATHETER. AS A RESULT, A NEW 35 CONTROLLABLE COIL WAS SUBSTITUTED. ADDITIONALLY, ONE UNIT OF THE SAME MODEL (M001363800) WAS REPLACED AS BACKUP. 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 22472937 ↗
• 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 WAS UNABLE TO ADVANCE IN THE MICROCATHETER. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A 10MM X 40CM INTERLOCK-35 COIL WAS SELECTED FOR USE IN AN EMBOLIZATION OF SPLENIC ANEURYSM. DURING THE PROCEDURE, THE COIL BECAME STUCK IN 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. HOWEVER, DEVICE ANALYSIS REVEALED DETACHED COIL ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22437248 ↗
• MalfunctionJun 23, 2025Stretched; Adverse Event Without Identified Device or Use Problem; Stretched; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26MAY2025. IT WAS REPORTED THAT THE COIL WAS STRETCHED. A 10MM X 40CM INTERLOCK-35 COIL WAS ADVANCED FOR EMBOLIZATION OF THE HEPATIC ARTERY. HOWEVER, THE COIL STRETCHED WHEN IT ENTERED THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE MAIN COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22309676 ↗
• MalfunctionMay 20, 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 24APR2025. IT WAS REPORTED THAT THE COIL WAS UNABLE TO ADVANCE IN CATHETER. PATIENT WAS PRESENTED WITH A SPLENIC ANEURYSM. A 10MM X 40CM INTERLOCK-35 SELECTED FOR USE IN AN EMBOLIZATION. DURING THE PROCEDURE, THE COIL COULD NOT BE DELIVERED OUT WHEN IT REACHED THE ORIFICE IN THE ANGIOGRAPHIC CATHETER. THE COIL WAS ATTEMPTED TO BE WITHDRAWN AND RELEASE IT AGAIN BUT STILL THE COIL COULD NOT BE DELIVERED. AT THIS TIME, HEPARIN SALINE WAS CONTINUOUSLY DRIPPED. 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 ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22056621 ↗
• MalfunctionApr 30, 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 10APR2025. IT WAS REPORTED THAT COIL WAS UNABLE TO ADVANCE IN THE CATHETER. PATIENT WAS PRESENTED WITH AN ABDOMINAL AORTIC ANEURYSM. A 10MM X 40CM INTERLOCK 35 WAS SELECTED FOR USE IN AN INTERNAL ILIAC EMBOLIZATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL BECAME STUCK AND COULD NOT BE ADVANCED. 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 ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21935422 ↗
• MalfunctionMar 27, 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 28FEB2025. IT WAS REPORTED THAT INSERTION DIFFICULTY OCCURRED. A 10MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE IN AN ENDOVASCULAR ANEURYSM REPAIR. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS DIFFICULT TO INSERT INSIDE THE NON-BOSTON SCIENTIFIC IMAGING CATHETER. ONLY THE MAIN COIL WAS REMOVED, AND 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 ZAP TIP WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21712855 ↗
• MalfunctionMar 24, 2025Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24FEB2025. IT WAS REPORTED THAT THE COIL WAS UNABLE TO ADVANCE. A 10MM X 40CM, INTERLOCK-35 WAS SELECTED FOR USE IN THE EMBOLIZATION OF A SPLENIC ANEURYSM. DURING THE PROCEDURE, THE COIL WAS DELIVERED USING A NON-BOSTON SCIENTIFIC (BSC) CATHETER. HEPARIN SALINE INFUSION WAS PERFORMED THROUGHOUT, WITH CONTINUOUS FLUSHING, WHICH WAS PERFORMED PRIOR TO COIL INTRODUCTION. HOWEVER, IT WAS NOTED THAT THE COIL COULD NOT CONTINUE ADVANCING AT THE DISTAL END OF THE CATHETER EVEN AFTER REPEATED ATTEMPTS. THE COIL WAS REMOVED FROM THE PATIENT'S 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'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THE ARM OF THE COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21680274 ↗
• MalfunctionMar 24, 2025Stretched; Failure to Advance; Separation Failure; Stretched; Failure to Advance; Separation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24FEB2025. IT WAS REPORTED THAT THE COIL WAS STRETCHED AND COULD NOT BE DEPLOYED. A 10MM X 40CM INTERLOCK-35 COIL WAS SELECTED FOR USE IN A RENAL ARTERY EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS STRETCHED AND COULD NOT BE DEPLOYED AFTER THE COIL WAS REPEATEDLY ADVANCED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE ARM OF THE COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21678619 ↗
• MalfunctionMar 20, 2025Difficult to Remove; Difficult to Remove

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2025. IT WAS REPORTED THAT THE COIL COULD NOT BE WITHDRAWN. A 10MM X 40CM INTERLOCK-35 COIL WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE IN THE INTERNAL ILIAC ARTERY. THE COIL WAS ADVANCED THROUGH A 5F NON-BOSTON SCIENTIFIC CATHETER. HOWEVER, THE POSITION OF THE COIL WAS NOT GOOD. UPON ATTEMPTED REMOVAL, IT WAS FOUND THAT THE COIL COULD NOT BE WITHDRAWN. THE COIL WAS THEN REMOVED TOGETHER WITH THE CATHETER. THE DEVICE WAS EXCHANGED FOR ANOTHER OF THE SAME COIL TYPE, AND THE COIL WAS DEPLOYED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING THE PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE COIL ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21655018 ↗
• MalfunctionJan 15, 2025Premature Activation; Failure to Advance; Difficult to Advance; Material Deformation; Premature Activation; Failure to Advance; Difficult to Advance; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20DEC2024. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCE. THE PATIENT HAD ABDOMINAL AORTIC ANEURYSM AND INTERNAL ILIAC ARTERY ANEURYSM. DURING THE PROCEDURE, A 15X40 INTERLOCK-35 COIL WAS PLACED FOR EMBOLIZATION, AND THEN THIS 10MM X 40CM INTERLOCK-35 COIL WAS SELECTED. WHEN THIS COIL WAS CROSSED, THERE WAS RESISTANCE OCCURRED, AND IT COULD NOT BE PUSHED OUT. AFTER REPEATED ATTEMPTS, THIS COIL WAS WITHDRAWN AND FOUND THE HEAD END OF THE COIL WAS KINK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED DETACHED COIL ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21164033 ↗
• MalfunctionDec 13, 2024Separation Failure; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Separation Failure; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25NOV2024. IT WAS REPORTED THAT THE COIL FAILED TO DEPLOY. THE TARGET LESION WAS LOCATED IN THE PELVIC HEMORRHAGE. AFTER A SUCCESSFUL EMBOLIZATION IN THE EXTERNAL ILIAC ARTERY, THE PROCEDURE CONTINUED, AND A 10MM X 40CM INTERLOCK-35 CUBE COIL WAS ADVANCED ALONG WITH NON-BOSTON SCIENTIFIC CATHETER. HOWEVER, IT WAS DIFFICULT TO ADVANCE IN THE CATHETER AT ABOUT HALFWAY, AND IT COULD NOT BE RELEASED. THE DEVICE WAS REPLACED WITH ANOTHER 10MM X 40CM INTERLOCK-35 COIL, BUT THE PROBLEM STILL OCCURRED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, 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 20924943 ↗
• MalfunctionDec 13, 2024Separation Failure; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Separation Failure; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25NOV2024. IT WAS REPORTED THAT THE COIL FAILED TO DEPLOY. THE TARGET LESION WAS LOCATED IN THE PELVIC HEMORRHAGE. AFTER A SUCCESSFUL EMBOLIZATION IN THE EXTERNAL ILIAC ARTERY, THE PROCEDURE CONTINUED, AND A 10MM X 40CM INTERLOCK-35 CUBE COIL WAS ADVANCED ALONG WITH NON-BOSTON SCIENTIFIC CATHETER. HOWEVER, IT WAS DIFFICULT TO ADVANCE IN THE CATHETER AT ABOUT HALFWAY, AND IT COULD NOT BE RELEASED. THE DEVICE WAS REPLACED WITH ANOTHER 10MM X 40CM INTERLOCK-35 COIL, BUT THE PROBLEM STILL OCCURRED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, 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 20924932 ↗
• MalfunctionDec 4, 2024Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06NOV2024. IT WAS REPORTED THAT PREMATURE DEPLOYMENT OCCURRED. A 10MM X 40CM INTERLOCK-35 CUBE COIL WAS ADVANCED FOR PARTIAL SPLENIC ARTERY EMBOLIZATION. DURING THE PROCEDURE, THE LOCKING ARM WAS RELEASED PREMATURELY IN THE RENEGADE STC-35 MICROCATHETER AND COULD NOT BE ADVANCED FORWARD. THE PHYSICIAN REMOVED THE DELIVERY SYSTEM TOGETHER WITH THE COIL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE COIL ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20847002 ↗
• MalfunctionDec 4, 2024Stretched; Difficult to Advance; Stretched; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06NOV2024. IT WAS REPORTED THAT THE COIL WAS UNABLE TO ADVANCE IN THE CATHETER AND THE COIL WAS STRETCHED. THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY. A 10MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE IN AN EMBOLIZATION OF ABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE, THERE WAS GREAT RESISTANCE WHEN ADVANCING THE COIL INTO THE NON-BOSTON SCIENTIFIC ANGIOGRAPHIC CATHETER. THE COIL WAS WITHDRAWN, AND IT WAS NOTED THAT THE COIL WAS STRETCHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE MAIN COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20846775 ↗
• MalfunctionNov 4, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE TARGET LOCATION WAS IN THE MODERATELY TORTUOUS SUBCLAVIAN ARTERY. A 10MM X 40CM INTERLOCK-35 COIL WAS SELECTED FOR USE FOLLOWING STENT GRAFT INSERTION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL BECAME STUCK INSIDE THE CATHETER. CONSEQUENTLY, THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT INJURY WAS REPORTED. IT WAS FURTHER REPORTED THAT THE PATIENT WAS LOCALLY SEDATED WHEN THE ISSUE OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20604215 ↗
• MalfunctionOct 31, 2024Separation Failure; Adverse Event Without Identified Device or Use Problem; Separation Failure; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT COIL DEPLOYMENT ISSUE OCCURRED. THE TARGET LESION WAS LOCATED IN THE AORTA. A 10MM X 40CM INTERLOCK .35 WAS SELECTED FOR AORTOGRAPHY AND EMBOLIZATION. DURING THE PROCEDURE, THE COIL WAS DELIVERED INTO THE EMBOLIZATION SITE THROUGH THE 5F ANGIOGRAPHY CATHETER. HOWEVER, DURING THE RELEASE PROCESS, THE COIL COULD NOT BE RELEASED HALFWAY THROUGH AND COULD NOT BE WITHDRAWN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE ZAP TIP WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20578240 ↗