Interlock™-35 M001363630Recalls & reported problems

Summary

The FDA's MAUDE database contains 72 adverse event reports that list this exact device (DI 08714729792970), received between Aug 22, 2017 and Apr 20, 2026 — classified as 7 injuries, 65 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (23 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 72 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 20, 2026Stretched; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27MAR2026. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED AND STRETCHED. THE TARGET LESION WAS LOCATED IN THE SPLEEN. A 12MM X 40 CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL COULD NOT BE ADVANCED THROUGH THE 5F NON-BOSTON SCIENTIFIC ANGIOGRAPHY CATHETER, LIKELY AT THE CATHETER TIP. THE COIL WAS WITHDRAWN FROM THE BODY, AND IT WAS FOUND TO BE STRETCHED. 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 ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24927660 ↗
• MalfunctionMar 24, 2026Entrapment of Device; Stretched; Failure to Advance

  IT WAS REPORTED THAT PART OF THE COIL STUCK TO THE CATHETER TIP AND COULD NOT BE WITHDRAWN. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTA AND ILIAC ARTERY. A 12MM X 40CM INTERLOCK - 35 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS ADVANCED; HOWEVER, AFTER APPROXIMATELY 2 CM OF DEPLOYMENT, THE POSITION WAS SUBOPTIMAL, AND THE COIL WAS RETRACTED AND RE-ADVANCED. DURING SUBSEQUENT DEPLOYMENT, APPROXIMATELY ONE-THIRD OF THE COIL WAS DEPLOYED WHEN IT BECAME STUCK AND COULD NOT BE ADVANCED OR WITHDRAWN. THE COIL AND THE SINGLE CURVE CATHETER WERE REMOVED FROM THE PATIENT TOGETHER AS ONE UNIT. THE SAME COIL WAS RELOADED AND REATTEMPTED FOR DELIVERY; HOWEVER, THE COIL AGAIN BECAME STUCK AFTER PARTIAL DEPLOYMENT AND COULD NOT BE ADVANCED. THE ENTIRE SYSTEM WAS WITHDRAWN, AND INSPECTION REVEALED THE COIL BODY WAS STRETCHED AND COULD NOT BE DEPLOYED. THE COIL AND CATHETER WERE REMOVED TOGETHER FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING TWO ADDITIONAL COILS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT NO PORTION OF THE COIL WAS PROTRUDING FROM THE CATHETER TIP UPON REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24674485 ↗
• MalfunctionJan 20, 2026Separation Failure; Difficult to Advance

  IT WAS REPORTED THAT PROCEDURE WAS CANCELLED. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 12MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL DID NOT ADVANCE IN THE CATHETER AND WHEN ATTEMPTED TO RELEASE THE INTERLOCK, THE RELEASE MECHANISM FAILED TO FUNCTION AS INTENDED. MULTIPLE ATTEMPTS WERE MADE TO RELEASE THE DEVICE, BUT ALL WERE UNSUCCESSFUL. THE COIL WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24119910 ↗
• MalfunctionDec 22, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THAT VASCULAR SPASM NOTED DURING RE-SELECTION ATTEMPTED RESULTING IN PROCEDURE CANCELLED. PATIENT WAS PRESENTED WITH PELVIC CONGESTION SYNDROME. A 12MM X 40CM INTERLOCK -35 WAS SELECTED FOR USE IN AN EMBOLIZATION. DURING THE PROCEDURE, THE INITIAL COIL CONFIGURATION WAS UNSATISFACTORY. DURING RETRIEVAL FOR RE-DEPLOYMENT, THE COIL BECAME STUCK, REQUIRING WITHDRAWAL OF THE ENTIRE SYSTEM. WHILE PREPARING FOR A NEW COIL, THE NON-BOSTON SCIENTIFIC GUIDE CATHETER DISLODGED FROM THE LEFT RENAL VEIN, AND ATTEMPTS TO RE-SELECT WERE COMPLICATED BY VASCULAR SPASM, LEADING TO TERMINATION OF THE PROCEDURE. THERE WERE NO PATIENT COMPLICATION AS THE RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS UNDER LOCAL ANESTHESIA. THE PROCEDURE WAS PAUSED TO RELIEVE THE VASOSPASM.

  Patient problems: Vasoconstriction

  MAUDE report 23864810 ↗
• MalfunctionDec 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 19NOV2025. IT WAS REPORTED THAT THE COIL WAS STUCK IN THE CATHETER AND BECAME STRETCHED. THE PATIENT PRESENTED WITH ABDOMINAL AORTIC ANEURYSM UNDERWENT EMBOLIZATION USING A 12MM X 40CM INTERLOCK-35 AND NON-BOSTON SCIENTIFIC CATHETER. HOWEVER, DURING THE PROCEDURE, THE COIL COULD NOT BE PUSHED OUT OF THE CATHETER, AND OBVIOUS RESISTANCE WAS FELT WHEN IT WAS PUSHED TO THE MIDDLE OF THE CATHETER. IT WAS JUDGED THAT THE COIL WAS STUCK IN THE CATHETER. AFTER THE PHYSICIAN WITHDREW THE DEVICE FROM THE PATIENT'S BODY AND THE CATHETER, IT WAS NOTED THAT THE COIL BECAME STRETCHED. 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 23791014 ↗
• MalfunctionDec 8, 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 DEVICE ANALYSIS COMPLETED ON 24NOV2025. IT WAS REPORTED THE DEVICE WAS UNABLE TO WITHDRAW FROM THE CATHETER. A 2D .035 12MM X 40CM INTERLOCK-35 DEVICE WAS SELECTED FOR AN EMBOLIZATION PROCEDURE TO TREAT FOR USE IN A PELVIC CONGESTION SYNDROME (PCS). DURING THE PROCEDURE, THE COIL BECAME DIFFICULT TO REMOVE FROM INSIDE OF THE CATHETER. A DIFFERENT DEVICE OF THE SAME MODEL WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, MICROSCOPIC DEVICE ANALYSIS REVEALED THE MAIN COIL OF THE DEVICE WAS DETACHED/SEPARATED, BENT AND STRETCHED. IN ADDITION, THE ARM COIL WAS NOTED TO BE DETACHED/SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23744833 ↗
• MalfunctionNov 12, 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 15OCT2025. IT WAS REPORTED THAT THE COIL COULD NOT BE PUSHED OUT AND BECAME DAMAGED. A 12MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR EMBOLIZATION OF AN INTERNAL ILIAC ARTERY ANEURYSM. DURING THE PROCEDURE, THE COIL BECAME STUCK IN THE CATHETER AND COULD NOT BE PUSHED OUT. UPON REMOVAL, IT WAS NOTED THAT THE COIL WAS DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF 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 OF THE COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23536820 ↗
• MalfunctionOct 24, 2025Failure to Advance; Separation Failure; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Separation Failure; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26SEP2025. IT WAS REPORTED THAT THE COIL GOT STUCK IN THE CATHETER. A 12MM X 40CM INTERLOCK-35 WAS SELECTED FOR PORTAL VEIN EMBOLIZATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK IN THE CATHETER AND COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THE MAIN COIL WAS DETACHED AT THE COIL ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23381340 ↗
• MalfunctionAug 28, 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 01AUG2025. IT WAS REPORTED THAT THE COIL WAS UNABLE TO ADVANCE IN THE CATHETER. A 12MM X 40CM .035 INTERLOCK 2D WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE IN THE RENAL ARTERY. DURING THE PROCEDURE, THE DEVICE COULD NOT BE DELIVERED OUT OF THE CATHETER. THE PHYSICIAN TRIED TO WITHDRAW IT MANY TIMES BUT STILL COULD NOT RELEASE IT. THE DEVICE WAS REMOVED. 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 OF THE RETURNED DEVICE REVEALED THE MAIN COIL WAS DETACHED AT THE ZAP TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22919302 ↗
• MalfunctionJul 28, 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 01JUL2025. IT WAS REPORTED THE COIL WAS UNABLE TO ADVANCE. THE TARGET LESION WAS LOCATED IN THE ARTERIA RENALIS. A 12MM X 40CM INTERLOCK .035 WAS SELECTED FOR RENAL ARTERY EMBOLIZATION. DURING PROCEDURE, FOLLOWING A SUCCESSFUL PUNCTURE OF THE RIGHT FEMORAL ARTERY, A 5F SHEATH WAS PLACED. A 5F NON-BOSTON SCIENTIFIC CATHETER WAS THEN ADVANCED THROUGH THE SHEATH. AN ATTEMPT TO DEPLOY A 12MM X 40CM INTERLOCK 35 COIL FAILED, AS THE COIL COULD NOT EXIT THE CATHETER DESPITE MULTIPLE 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 ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22639185 ↗
• MalfunctionMay 28, 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 30APR2025. IT WAS REPORTED THAT THE COIL PREMATURE DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTA. A 12MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE. DURING ADVANCEMENT, IT WAS NOTED THAT THE COIL WAS DEPLOYED PREMATURELY AND DID NOT REACH THE TUMOR. 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 ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22100064 ↗
• MalfunctionMar 28, 2025Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04MAR2025. IT WAS REPORTED THAT THE COIL COULD NOT BE DELIVERED. A 12MM X 40CM INTERLOCK-35 2D COIL WAS SELECTED FOR USE IN A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE. THE TARGET LOCATION WAS A SPLENIC ANEURYSM. CONTINUOUS FLUSHING WAS PERFORMED AS THE COIL WAS ADVANCED THROUGH A NON-BOSTON SCIENTIFIC RADIOGRAPHY CATHETER. HOWEVER, THE COIL COULD NOT BE PUSHED FORWARD DESPITE REPEATED ATTEMPTS. 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 THE PROCEDURE WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE ARM OF THE COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21719941 ↗
• 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 22FEB2025. IT WAS REPORTED THAT THE COIL WAS STUCK IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A 12MM X 40CM INTERLOCK-35 COIL WAS SELECTED FOR EMBOLIZATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS STUCK AFTER PUSHING PART OF THE COIL TO THE CATHETER, AND IT COULD NOT BE PUSHED OUT OF THE CATHETER AFTER MANY ATTEMPTS. THE COIL WAS WITHDRAWN, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED AN ARM COIL DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21662102 ↗
• MalfunctionMar 13, 2025Stretched; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Stretched; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16FEB2025. IT WAS REPORTED THAT THE COIL COULD NOT BE PUSHED OUT DUE TO OBVIOUS RESISTANCE AND WAS STRETCHED AFTER WITHDRAWAL. A 12MM X 40CM INTERLOCK-35 COIL WAS SELECTED FOR EMBOLIZATION OF SPLENIC ANEURYSM. DURING THE PROCEDURE, A NON-BOSTON SCIENTIFIC CATHETER WAS USED TO REACH THE LESION. HOWEVER, WHEN THE COIL WAS USED FOR THE FIRST PUSH, THE POSITION WAS NOT SATISFACTORY. AFTER WITHDRAWAL, THERE WAS OBVIOUS RESISTANCE DURING RE-DELIVERY, AND IT COULD NOT BE PUSHED OUT OF THE ANGIOGRAPHY CATHETER. AFTER THE WITHDRAWAL OF THE COIL, IT WAS FOUND THAT THE COIL HAD BEEN STRETCHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21596396 ↗
• MalfunctionJan 17, 2025Stretched; Failure to Advance; Stretched; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS ON 25DEC2024. IT WAS REPORTED THAT THE COIL COULD NOT BE DELIVERED OUT AND THE COIL WAS STRETCHED. THE PATIENT WAS PRESENTED WITH FEMORAL ARTERY RUPTURE. A 12MM X 40CM INTERLOCK-35 WAS SELECTED FOR A DEEP FEMORAL ARTERY EMBOLIZATION. DURING THE PROCEDURE, THE COIL COULD NOT BE DELIVERED OUT. THE COIL WAS PULLED BACK AND FORTH, AND IT WAS FOUND THE COIL WAS STRETCHED. 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 DETACHED ARM COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21179650 ↗
• MalfunctionDec 31, 2024Stretched; Failure to Advance; Stretched; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12DEC2024. IT WAS REPORTED THAT COIL BECAME STUCK DURING DELIVERY. THE PATIENT UNDERWENT INTERNAL ILIAC ANEURYSM PROCEDURE. A 12MM X 40CM INTERLOCK-35 COIL WAS SELECTED FOR EMBOLIZATION. THE PHYSICIAN USED A 7F NON-BOSTON SCIENTIFIC LONG SHEATH TO CROSS AND AN IMAGING CATHETER; HOWEVER, THE COIL COULD NOT BE DELIVERED, IT BECAME STUCK. THE ANGLE WAS ADJUSTED MANY TIMES BUT FAILED. THE COIL WAS THEN REMOVED AND FOUND IT WAS STRETCHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME 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 21048725 ↗
• MalfunctionAug 21, 2024Difficult to Remove; Separation Failure; Difficult to Remove; Separation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29JUL2024. IT WAS REPORTED THAT THE COIL COULD NOT BE RELEASED OR REMOVED FROM THE CATHETER. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. AN 12MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS ADVANCED TO THE TARGET POSITION VIA THE IMAGING CATHETER. DURING DEPLOYMENT, THE COIL COULD NOT BE RELEASED OR REMOVED FROM THE CATHETER. 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 COIL DETACHED AT THE COIL ARM SECTION AND PRIMARY COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20020099 ↗
• MalfunctionJun 6, 2024Difficult 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 15MAY2024. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED IN THE CATHETER. PATIENT HAD AN ABDOMINAL AORTIC ANEURYSM AND UNDERWENT EMBOLIZATION LOCATED IN A MEDIUM TORTUOUS INTERNAL ILIAC ARTERY. A 6F SHEATH ASSISTED TO PLACE ANGIOGRAPHY CATHETER AND WAS LATER FOLLOWED BY A 5F CATHETER USED TO GUIDE 12MM X 40CM INTERLOCK .035 COIL TO EMBOLIZE. DURING THE PROCEDURE, THERE WAS DIFFICULTY ADVANCING AFTER SEVERAL ATTEMPTS. WHEN THE COIL WAS PULLED OUT, IT COULD NOT PUSH BACK AGAIN. THE DELIVERY WAS NOT ROTATED MORE THAN ONE TURN DURING DELIVERY AND THE TWIST LOCK WAS NOT FULLY OPENED. AFTER MANY FAILED ATTEMPTS, THE DEVICE WAS REMOVED TOGETHER WITH THE CATHETER AND WAS REPLACED FOR ANOTHER OF THE SAME MODEL TO COMPLETE THE PROCEDURE. IT WAS CONFIRMED COIL AND PUSHER WIRE ARMS WERE INTERLOCKED IN THE INTRODUCER SHEATH BEFORE USE AND THAT THE SHEATH WAS FIRMLY SEATED IN THE HUB OF THE CATHETER BEFORE ADVANCING THE COIL. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A DETACHED COIL AT THE ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19477211 ↗
• MalfunctionMar 19, 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 29FEB2024. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED FROM THE CATHETER. A 12MM X 40CM INTERLOCK-35 COIL WAS SELECTED FOR SPLENIC ARTERY EMBOLIZATION. DURING THE COURSE OF THE PROCEDURE, THERE WAS SOMETHING WRONG AT THE ENTRANCE OF THE DELIVERY SYSTEM AND THE COIL COULD NOT BE ADVANCED ANY MORE. THE COIL WAS WITHDRAWN FROM PATIENT'S BODY 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 A DETACHED ARM COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18937623 ↗
• MalfunctionMar 6, 2024Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13FEB2024. IT WAS REPORTED THAT THE COIL WAS STUCK. THE PATIENT WAS BEING TREATED FOR INTERNAL ILIAC ANEURYSM. A 12MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS DELIVERED HALFWAY WHEN IT COULD NO LONGER BE ADVANCED. THE COIL WAS WITHDRAWN. THE NON-BOSTON SCIENTIFIC IMAGING CATHETER WAS REPLACED, AND AN ATTEMPT WAS MADE TO ADVANCE THE SAME COIL AGAIN. HOWEVER, THE COIL BECAME STUCK AGAIN AND COULD NOT BE ADVANCED. THE COIL WAS THEREFORE REMOVED AND REPLACED WITH ANOTHER OF THE SAME DEVICE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO COMPLICATIONS REPORTED, AND THE PATIENT WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE ZAP TIP WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18852439 ↗
• MalfunctionMar 1, 2024Difficult to Remove; Stretched; Failure to Advance; Difficult to Remove; Stretched; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT THE COIL COULD NOT MOVE FORWARD AND WITHDRAW DIFFICULTLY, RESULTING THE COIL STRETCHED AFTER WITHDRAWAL. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 12MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, BEFORE ADVANCING, THE COIL WAS FLUSHED WITH HEPARIN. WHEN THE COIL ADVANCED 10CM, THE COIL COULD NOT MOVE FORWARD AND WITHDRAW DIFFICULTLY, RESULTING THE COIL STRETCHED AFTER WITHDRAWAL. THE DEVICE 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 ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18817661 ↗
• MalfunctionJan 10, 2024Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20DEC2023. IT WAS REPORTED THAT THE COIL WAS STUCK IN THE CATHETER. THE PATIENT WAS BEING TREATED FOR ABDOMINAL AORTIC ANEURYSM AND UNDERWENT BILATERAL INTRA-ILIAC EMBOLIZATION. A 12MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE INTERLOCK WAS ADVANCED WITH A NON-BOSTON SCIENTIFIC ANGIOGRAPHIC CATHETER. BEFORE ADVANCING THE DEVICE HAS BEEN FLUSHED BY HEPARIN SALINE, THE POSITION SHOULD BE ADJUSTED DURING ADVANCING, HOWEVER IT WAS FOUND THAT THE DEVICE WAS STUCK IN MIDDLE PART OF THE CATHETER, AND THE COIL WERE RELEASED IN THE ANGIOGRAPHIC CATHETER. THE COIL WAS REMOVED WITH THE CATHETER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, DEVICE INVESTIGATIONS REVEALED THAT THE MAIN COIL WAS DETACHED AT THE ZAP TIP SECTION, PRIMARY COIL AND ARM COIL SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18486589 ↗
• MalfunctionDec 14, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT THE COIL WAS STUCK IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE FEMORAL ARTERY. AN 12MM 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, THE COIL COULD NOT BE PUSHED OUT. DURING THE OPERATION, WATER FLUSHING WAS APPLIED, BUT IT STILL COULD NOT BE RELIEVED. THE DEVICE WAS REMOVED TOGETHER WITH THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS 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 18326360 ↗
• MalfunctionDec 5, 2023Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT THE COIL COULD NOT ADVANCE OUT OF THE IMAGING CATHETER. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTA. A 12MM X 40CM INTERLOCK-35 COIL WAS SELECTED FOR USE. THE IMAGING CATHETER WAS CONNECTED WITH HIGH PRESSURE SALINE AND WAS FLUSHED INTERMITTENTLY BEFORE INTRODUCTION OF THE COIL. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT ADVANCE OUT OF THE 5F CORDIS CATHETER. WHEN ADVANCE FOR THE SECOND TIME, IT GOT DETACHED INSIDE THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE MAIN COIL DETACHED AT THE COIL ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18268888 ↗
• InjuryDec 5, 2023Premature Activation; Malposition of Device; Premature Activation; Malposition of Device

  IT WAS REPORTED THAT THE COIL WAS RETRIEVED BY SNARE INSIDE THE BODY. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED VESSEL. A 12MM X 40CM INTERLOCK-35 COIL AND 10MM X 50CM INTERLOCK COIL WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL DETACHED PREMATURELY IN THE CATHETER DISTAL PART AND LATER FLOWED UNINTENTIONALLY INSIDE THE BODY. THE COIL WAS COMPLETELY RETRIEVED BY SNARE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18268480 ↗