Interlock™-35 M001363550Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 08714729793021), received between Oct 18, 2018 and Jul 6, 2026 — classified as 4 injuries, 28 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (10 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 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 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 THE COIL WAS UNABLE TO ADVANCE IN THE CATHETER. A 6MM X 20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL DID NOT COME OUT OF 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 DETACHED ARM COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25725402 ↗
• MalfunctionJun 30, 2026Difficult to Remove; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. AN INTERLOCK? -35 EMBOLIC COIL WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE FOR PELVIC CONGESTION SYNDROME (PCS). DURING THE PROCEDURE, THERE WAS DIFFICULTY/INABILITY ADVANCING AND RETRACTING THE COIL. THE COIL COULD NOT BE DEPLOYED. THE COIL HAD TO BE WITHDRAWN TOGETHER WITH THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THE INTERLOCKING ARM OF THE COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25668784 ↗
• MalfunctionJun 24, 2026Premature Activation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26MAY2026. IT WAS REPORTED THAT THE COIL PREMATURELY DEPLOYED. A 6MM X 20CM INTERLOCK .035 COIL WAS SELECTED FOR USE IN THE STOMACH. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS DETACHED IN THE MICROCATHETER. 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 ARM WAS WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25610805 ↗
• MalfunctionMay 15, 2026Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT COIL WAS UNABLE TO ADVANCED IN THE CATHETER. A 6MM X 20CM INTERLOCK? -35 WAS SELECTED FOR USE. DURING THE PROCEDURE, WHILE ADVANCING THE PUSHABLE WIRE TO DEPLOY THE COIL, RESISTANCE WAS ENCOUNTERED. THE DEVICE WAS NOT USED FURTHER, AND THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WERE NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A MAIN COIL DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25194377 ↗
• InjuryDec 2, 2025Stretched; Adverse Event Without Identified Device or Use Problem; Stretched; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COIL UNRAVELED, REQUIRING INTERVENTION. A 6MM X 20CM INTERLOCK?-35 WAS SELECTED FOR USE IN AN ARTERIOVENOUS MALFORMATION (AVM) EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL UNRAVELED DURING DEPLOYMENT AND HAD TO BE SNARED OUT OF THE BODY TO REMOVE IT. THE PROCEDURE WAS COMPLETED, AND THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23699962 ↗
• MalfunctionSep 16, 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 21AUG2025. IT WAS REPORTED THAT THE PREMATURE DEPLOYMENT OCCURRED. A 6MM X 20CM INTERLOCK-35 COIL WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT ADVANCE AT THE MIDDLE PART OF THE CATHETER. CONSEQUENTLY, THE COIL GOT DETACHED WHILE TRYING TO BE PUSHED INSIDE THE CATHETER. THE COIL WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH AN ALTERNATIVE 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 23065248 ↗
• MalfunctionAug 20, 2025Separation 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 24JUL2025. IT WAS REPORTED THAT COIL WAS UNABLE TO DEPLOY. THE TARGET LESION WAS LOCATED IN A VESSEL OF THE TESTIS. A 6MM X 20CM INTERLOCK -35 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE DEPLOYED. 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 ARM COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22855351 ↗
• MalfunctionJun 23, 2025Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27MAY2025. IT WAS REPORTED THAT THE COIL WAS DROOPING. THE TARGET LESION WAS LOCATED IN THE TESTIS ARTERY. A 6MM X 20CM, INTERLOCK .035 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS DROOPING. DUE TO UNINTENTIONAL DETACHMENT, IT WAS HARD TO DO EMBOLIZATION AS PLANNED WITH THE DEVICE. 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 22310705 ↗
• MalfunctionJun 13, 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 19MAY2025. IT WAS REPORTED THAT COIL BECAME STUCK IN THE MIDDLE PART OF THE CATHETER. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED LEFT INTERNAL ILIAC ARTERY. A 6MM X 20CM INTERLOCK?-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL BECAME STUCK IN THE MIDDLE PART OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 22206377 ↗
• MalfunctionMar 17, 2025Failure to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18FEB2025. IT WAS REPORTED THAT THE COIL WAS STUCK AND COULD NOT BE ADVANCED. THE TARGET LESION WAS LOCATED IN THE VERY TORTUOUS FEMORAL ARTERY. A 6MM X 20CM INTERLOCK-35 COIL WAS SELECTED FOR EMBOLIZATION OF SPLENIC ANEURYSM. DURING THE PROCEDURE, NON-BOSTON SCIENTIFIC DEVICES WERE USED TO ADVANCE THE COIL. HOWEVER, IT WAS NOTED THAT THE COIL WAS STUCK, AND IT COULD NOT BE ADVANCED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 21620549 ↗
• MalfunctionNov 21, 2024Material Integrity Problem; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01NOV2024. IT WAS REPORTED THAT THE COIL WAS LESS CURLED. THE TARGET LESION WAS LOCATED IN THE VESSEL OF THE TESTIS. A 6MM X 20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS LESS CURLED AND APPEARS TO BE INSUFFICIENT FOR EMBOLIZATION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT 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 20747123 ↗
• MalfunctionNov 12, 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 16OCT2024. IT WAS REPORTED THAT THE COIL FAILED TO ADVANCE AND GOT STRETCHED. THE PATIENT PRESENTED WITH SPLENIC ANEURYSM UNDERWENT AN EMBOLIZATION. A 6MM X 20CM INTERLOCK .035 COIL INFUSED WITH HEPARIN SALINE WAS SELECTED FOR USE. DURING THE PROCEDURE, A NON-BOSTON SCIENTIFIC (BSC) ANGIOGRAPHY CATHETER WAS USED TO REACH THE LESION SITE. HOWEVER, UPON DEPLOYMENT, IT WAS NOTED THAT THE POSITION OF THE COIL WAS UNSATISFACTORY. AFTER THE WITHDRAWAL, THE CATHETER COULD NOT BE PUSHED OUT AGAIN DUE TO OBVIOUS RESISTANCE, AND IT WAS FOUND THAT THE COIL HAD BEEN 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 THE ZAP TIP WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20667011 ↗
• MalfunctionJun 12, 2023Premature Activation; Premature Activation

  REPORTABLE BASED ON DEVICE INVESTIGATIONS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT PREMATURE DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE VARICOSE VEINS OF THE FUNDUS OF THE STOMACH WITH SEVERE TORTUOSITY. A 6MM X 20CM INTERLOCK .035 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE INTERLOCKING ARM OF THE COIL DETACHED/UNLOCKED FROM THE INTERLOCKING ARM OF THE PUSHER WIRE. THE COIL AND THE CATHETER WERE REMOVED DIRECTLY AS A WHOLE AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS AND THE PATIENT IS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE COIL WAS DETACHED AT THE COIL ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17107066 ↗
• MalfunctionMay 30, 2023Difficult to Remove; Difficult to Remove

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT THE COIL COULD NOT BE REMOVED FROM THE CATHETER. A 6MM X 20CM INTERLOCK -35 COIL WAS SELECTED FOR USE IN THE VARICOSE VEINS OF GASTRIC FUNDUS. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE WITHDRAWN FROM THE CATHETER NORMALLY. THE DEVICE WAS REMOVED TOGETHER WITH 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 WAS DETACHED AT THE COIL ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17019868 ↗
• MalfunctionFeb 27, 2023Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 06FEB2023. IT WAS REPORTED THAT THE COIL BECAME STUCK INSIDE THE CATHETER. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED INTERNAL ILIAC ARTERY. A 6MMX20CM INTERLOCK-35 COIL WAS SELECTED FOR USE IN THE ANEURYSM. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE GOT STUCK INSIDE THE ANGIOGRAPHIC CATHETER AT ABOUT 10CM FROM THE CATHETER HUB. THE COIL WAS REMOVED FROM THE PATIENT'S BODY WITHOUT PROBLEM AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY. HOWEVER, DEVICE ANALYSIS REVEALED A MAIN COIL DETACHED AT THE INTERLOCKING ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16448514 ↗
• MalfunctionJan 13, 2023Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT THE DEVICE WAS STUCK IN THE MICROCATHETER. THE TARGET LESION WAS LOCATED IN THE PELVIC CAVITY. A 6MM X 20CM INTERLOCK .035 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS STUCK IN THE MIDDLE OF THE NON-BOSTON SCIENTIFIC MICROCATHETER. THE COIL WAS WITHDRAWN FROM THE SHEATH AND REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE. HOWEVER, DEVICE INVESTIGATIONS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16163919 ↗
• MalfunctionDec 22, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07DEC2022. IT WAS REPORTED THAT DEVICE WAS UNABLE TO ADVANCE IN THE CATHETER AND WAS STRETCHED. A 6MMX20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, AN 8MMX40CM COIL WAS RELEASED FIRST, FOLLOWED BY THE DEVICE. HOWEVER, THE DEVICE COULD NOT BE DELIVERED. THE PHYSICIAN TRIED FOR SEVERAL TIMES TO MOVE IT GENTLY, BUT IT COULD NOT BE PUSHED OUT. WHEN THE DEVICE WAS REMOVED, IT WAS STRETCHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM OF THE MAIN COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16035170 ↗
• MalfunctionDec 15, 2022Break; Separation Failure; Poor Visibility; Break; Separation Failure; Poor Visibility

  IT WAS REPORTED THAT THE COIL BROKE IN HALF AND VESSEL SPASM OCCURRED. A 6MM X 20CM INTERLOCK-35 WAS SELECTED FOR USE IN THE VARICOCELES. DURING THE PROCEDURE, THE COIL AND CATHETER WERE FLUSHED. THE PLASTIC INTRODUCER SHEATH WAS SEATED IN THE HUB OF THE NON-BOSTON SCIENTIFIC CATHETER. THE PLASTIC INTRODUCER COULD NOT BE ADVANCED ANY FURTHER, AND THAT THE TIP WAS IN THE LUMEN OF THE CATHETER, BEYOND THE HUB. THE Y ADAPTER WAS GENTLY TIGHTENED TO GRIP THE PLASTIC SHEATH AND THE TWIST LOCK WAS UNTWISTED. THE COIL WIRE AND THE CATHETER WERE ADVANCED UNTIL THE TIP WAS POSITIONED CORRECTLY, AND THE COIL WAS DEPLOYED IN PLACE. THE MARKER TO IDENTIFY WHERE THE INTERLOCKING ARMS WERE WAS NOT VISIBLE. THE PHYSICIAN THOUGHT THAT HE HAD FINISHED DEPLOYING THE COIL, AND THAT THE INTERLOCKING ARMS HAD DETACHED. THE WIRE WAS RETRIEVED, AND THE PHYSICIAN BEGAN PREPARING FOR THE THIRD COIL. HOWEVER, UPON TURNING BACK TO THE PATIENT, IT WAS NOTED THAT THE LAST COIL WAS NOT IN PLACE AND HAD NOT BEEN DEPLOYED; INSTEAD, THE COIL HAD BEEN DRAGGED BACK BY THE WIRE, INTO THE CATHETER AND WAS HALF IN THE HUB OF THE CATHETER AND HALF BROKEN ON THE SCRUB TABLE, NEAR THE WIRE. THE BROKEN HALF OF THE COIL COU

  Patient problems: Vasoconstriction

  MAUDE report 15987188 ↗
• MalfunctionApr 5, 2022Difficult to Insert; Difficult to Insert

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15MAR2022. IT WAS REPORTED THAT THE COIL WAS DIFFICULT TO INSERT. A 6MMX20CM INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS DIFFICULT TO INSERT IN THE CATHETER HUB PART. THE COIL WAS REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WAS NO PATIENT INJURY. HOWEVER, DEVICE ANALYSIS REVEALED MISSING FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14017955 ↗
• MalfunctionDec 20, 2021Break; Break

  IT WAS REPORTED THAT THE TIP SEPARATED. A 6MM X 20CM INTERLOCK-35 WAS SELECTED FOR USE. AFTER REMOVAL OF THE COIL, THE CATHETER WAS TRIED TO REMOVE AND COIL WAS PULLED TOGETHER. SUBSEQUENTLY, THE BALLOON WAS DILATED AND PLACED IN THE LESION SITE. HOWEVER, THE TIP SEPARATED WHEN THE CATHETER WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13043043 ↗
• MalfunctionOct 20, 2021Separation Failure; Separation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30SEP2021. IT WAS REPORTED THAT THE DEVICE COULD NOT BE REMOVED IN THE PROTECTIVE SHEATH. A 6MM X 20CM INTERLOCK -35 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE REMOVED IN THE PROTECTIVE SHEATH. THE DEVICE WAS SIMPLY PULLED OUT FROM THE PATIENT'S BODY. THE PROCEDURE COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT 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 12667916 ↗
• InjuryJun 14, 2021Stretched; Adverse Event Without Identified Device or Use Problem; Stretched; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ADDITIONAL INTERVENTION WAS PERFORMED TO REMOVE A COIL. A 6MMX20CM .035 INTERLOCK 2D EMBOLIC COIL WAS SELECTED FOR USE. THE TARGET LOCATION WAS LOCATED IN AN OVARIAN VEIN. AFTER DEPLOYMENT, THE PHYSICIAN NOTICED A WIRE HANGING LOOSE FROM THE COIL. THE DEPLOYMENT WAS NOTED TO BE LESS SMOOTH THAN NORMAL. THE COIL WAS STRETCHED FROM THE OVARIAN VEIN INTO THE ILIAC VEIN AND VENA CAVA. THE PHYSICIAN DECIDED TO REMOVE THE COIL VIA A SNARE. ANOTHER .035 INTERLOCK DEVICE WAS USED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11992605 ↗
• MalfunctionMay 11, 2021Premature Activation; Separation Failure; Premature Activation; Separation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 20APR2021. IT WAS REPORTED THAT THE COIL DETACHED PREMATURELY INSIDE THE CATHETER. THE TARGET LESION WAS LOCATED IN THE OVARIAN VEIN. A 6MMX20CM 2D INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL DID NOT DETACH EVEN WHEN THE PHYSICIAN USED A SLIGHT TWISTING MOTION TO HELP DETACH THE COIL OUTSIDE THE CATHETER. THE PHYSICIAN RETRIEVED THE COIL AND IT WAS FOUND THAT THE COIL DETACHED PREMATURELY WITHIN THE 5F CATHETER. THE COIL WAS REMOVED FROM INSIDE OF THE 5F CATHETER 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 DETACHED INTERLOCKING ARM AND MISSING FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11808999 ↗
• InjuryJan 21, 2021Migration; Migration

  IT WAS REPORTED THAT COIL MIGRATED TO THE RENAL VEIN. THE TARGET LESION WAS LOCATED IN THE OVARIAN VEIN. A 6MMX20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS DEPLOYED IN THE OVARIAN VEIN BUT MIGRATED TO THE RENAL VEIN AND HAD TO BE RETRIEVED USING ALLIGATOR CLIPS. THE PROCEDURE WAS CANCELLED AS THE OVARIAN VEIN WAS TOO SMALL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY. THE PATIENT WAS STABLE POST AND THE PROCEDURE WILL NO LONGER BE RESCHEDULE.

  Patient problems: Embolism; Embolism/Embolus

  MAUDE report 11206826 ↗
• MalfunctionJan 6, 2021Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2020. IT WAS REPORTED THAT THE COIL WAS STUCK IN THE CATHETER DURING DELIVERY. A 6MMX20CM 2D INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, AFTER DELIVERING TWO COILS THROUGH THE .035 4F BERN IMAGER CATHETER, IT WAS NOTED THAT HALF OF THE COIL WAS DELIVERED TO THE TARGET VESSEL. THEN, THE PHYSICIAN COULD NO LONGER PUSH. AFTER MANY IMAGES AND ATTEMPTS TO USE THE PUSHER WIRE AND OTHERS, THE PHYSICIAN WAS FORCED TO DRAG THE IMAGER CATHETER OUT OF THE ARM TO RECAPTURE THE COIL. THE PROCEDURE WAS COMPLETED WITH ANOTHER INTERLOCK DEVICE. NO COMPLICATIONS WERE REPORTED AND THERE WERE NO NEGATIVE PATIENT CONSEQUENCES. HOWEVER, DEVICE ANALYSIS REVEALED A DETACHED INTERLOCKING ARM OF THE COIL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11125326 ↗