Interlock™-35 M001363650Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 08714729793144), received between Sep 17, 2018 and May 19, 2026 — classified as 3 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (12 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Premature Activation; Difficult to Remove; 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 IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED AND WITHDRAWN FROM THE CATHETER. A 15MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS STUCK IN THE CATHETER AND COULD NOT BE WITHDRAWN. 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 BENT AND STRETCHED AT THE PRIMARY COIL SECTION, MOREOVER THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25222640 ↗
• MalfunctionFeb 16, 2026Nonstandard Device; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21JAN2026. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED FROM THE CATHETER. A 15MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR USE IN THE COMMON ILIAC ARTERY ANEURYSM. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE ADVANCED FROM 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 A DETACHED COIL ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24350950 ↗
• MalfunctionFeb 16, 2026Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21JAN2026. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED FROM THE CATHETER. A 15MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR USE IN THE OVARIAN VEIN EMBOLISM. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE ADVANCED FROM 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 A DETACHED COIL ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24350935 ↗
• MalfunctionDec 5, 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 08NOV2025. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED FORWARD. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTIC ANEURYSM. A 15MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSM WITH COVERED STENT. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE ADVANCED FORWARD WHEN IT WAS IN PLACE. THE COIL STILL COULD NOT BE PUSHED AND DETACHED AFTER THE CATHETER WAS ADJUSTED AND REPLACED. 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 MAIN COIL WAS DETACHED AT MIDDLE SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23730339 ↗
• MalfunctionOct 22, 2025Difficult to Remove; Stretched; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Stretched; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25SEP2025. IT WAS REPORTED THAT THE COIL BECAME STRETCHED AND COULD NOT BE ADVANCED NOR WITHDRAWN FROM THE CATHETER. A 15MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR USE IN AN ILIAC ANEURYSM FOR AN ABDOMINAL AORTIC DISSECTION REPAIR. HOWEVER, DURING THE DELIVERY, THE COIL WAS STRETCHED HALFWAY AND COULD NOT BE FURTHER ADVANCED. ATTEMPTS TO RETRACT IT INTO THE DELIVERY SHEATH WERE UNSUCCESSFUL, NECESSITATING THE WITHDRAWAL OF THE ENTIRE DELIVERY SYSTEM. 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 23358022 ↗
• MalfunctionAug 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 15JUL2025. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A 15MM X 40CM INTERLOCK?-35 COIL WAS SELECTED FOR EMBOLIZATION. DURING THE PROCEDURE, A 5 F ANGIOGRAPHY CATHETER WAS USED TO DELIVER THE COIL WITH HEPARIN SALINE INFUSION THROUGHOUT, CONTINUOUS FLUSHING, AND IT WAS FLUSHED PRIOR TO COIL INTRODUCTION. HOWEVER, IT COULD NOT CONTINUE TO ADVANCE AT THE DISTAL END OF THE CATHETER, AND THE PROBLEM STILL OCCURRED AFTER REPEATED ATTEMPTS. THE COIL WAS WITHDRAWN FROM THE PATIENT'S BODY, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY REPLACING IT WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A MAIN COIL DETACHMENT AT THE COIL ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22795570 ↗
• MalfunctionJul 21, 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 26JUN2025. IT WAS REPORTED THAT THE COIL WAS PREMATURELY DEPLOYED AND UNABLE TO ADVANCE IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 15MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE IN AN ILIAC ARTERY EMBOLIZATION. DURING THE PROCEDURE, THE COIL WAS DELIVERED USING A 5F ANGIOGRAPHY CATHETER. THE HEPARIN NORMAL SALINE PERFUSION WAS PERFORMED WITH CONTINUOUS FLUSHING, AND FLUSHING WAS PERFORMED BEFORE INTRODUCING THE COIL. HOWEVER, IT WAS NOTED THAT THE COIL WAS PREMATURELY RELEASED AT THE OUTLET OF THE MICROCATHETER, AND IT COULD NOT BE ADVANCED FURTHER. THE COIL WAS REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT STATUS WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED DETACHED ARM COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22556793 ↗
• MalfunctionJun 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 19MAY2025. IT WAS REPORTED THAT THE COIL COULD NOT BE PUSHED OUT. THE TARGET LESION WAS LOCATED IN THE ABDOMEN. A 15MM X 40CM INTERLOCK-35 COIL WAS SELECTED FOR SPLENIC ARTERY ANEURYSM PROCEDURE. HOWEVER, THE COIL COULD NOT BE PUSHED OUT OF THE SHEATH DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 MAIN COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22230643 ↗
• MalfunctionFeb 12, 2025Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A 15MM X 40CM INTERLOCK-35 COIL WAS SELECTED FOR A UROLOGY PROCEDURE. HOWEVER, IT WAS NOTED THAT THE USE OF THIS DEVICE FAILED, AND IT WAS NOT RELEASED INTO THE PATIENT'S ARTERY. THE DEVICE WAS THEN REMOVED FROM THE PATIENT'S BODY. CONSEQUENTLY, THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21369328 ↗
• MalfunctionNov 5, 2024Premature Activation; Stretched; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Premature Activation; Stretched; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16-OCT-2024. IT WAS REPORTED THAT THE COIL FAILED TO ADVANCE AND GOT STRETCHED. THE PATIENT UNDERWENT AN EMBOLIZATION OF A SPLENIC ANEURYSM IN THE SPLENIC ARTERY. A 15MM X 40MM INTERLOCK .035 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE GUIDEWIRE WAS USED TO PUNCTURE FROM THE RIGHT SIDE, AND A NON-BOSTON SCIENTIFIC (BSC) ANGIOGRAPHY CATHETER WAS USED TO REACH THE EMBOLIZATION SITE. HOWEVER, THE PHYSICIAN HAD A HARD TIME PUSHING THIS COIL AFTER THE FIRST COIL WAS SUCCESSFULLY DEPLOYED. AFTER PUSHING IT BACK AND FORTH SEVERAL TIMES AND PULLING IT OUT, IT WAS FOUND THAT THE COIL WAS UNLOADED IN THE ANGIOGRAPHY CATHETER. CONSEQUENTLY, THE COIL WAS STRETCHED. AFTER THE CATHETER WAS REPLACED AND THE MICROCATHETER WAS RE-SELECTED, THE PROCEDURE WAS COMPLETED WITH A 14 X 30 COIL. 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 20613804 ↗
• MalfunctionOct 1, 2024Stretched; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Stretched; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2024. IT WAS REPORTED THAT COIL WAS UNABLE TO ADVANCE AND WAS STRETCHED. THE PATIENT UNDERWENT TRANSJUGULAR INTRAHEPATIC PORTAL SHUNT AND EMBOLIZATION OF GASTRIC VARICES PROCEDURE. A 15MM X 40CM INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE PHYSICIAN USED A NON-BOSTON SCIENTIFIC (BSC) CATHETER TO REACH THE FUNDUS VEIN. HOWEVER, WHEN THE COIL WAS ADVANCED, THE COIL COULD NOT BE PUSHED OUT OF THE CATHETER DUE TO OBVIOUS RESISTANCE. CONSEQUENTLY, IT WAS NOTED THAT THE COIL WAS STRETCHED UPON WITHDRAWAL. 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 ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20344773 ↗
• InjuryFeb 7, 2024Malposition of Device; Positioning Problem; Migration; Malposition of Device; Positioning Problem; Migration

  IT WAS REPORTED THAT MALPOSITION OCCURRED REQUIRING ADDITIONAL INTERVENTION. A 15MM X 40CM INTERLOCK-35 WAS SELECTED FOR A PELVIC VEIN EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, THE TIP OF THE CATHETER MIGRATED INTO THE RIGHT ATRIUM FOLLOWING THE RELEASE OF THE INTERLOCK-35 COIL. THE PHYSICIAN ATTEMPTED TO RECOVER THE DEVICE USING A SNARE BUT FAILED. THE PATIENT WAS REFERRED TO A CARDIOLOGIST FOR ANOTHER ATTEMPT WITH AN INTRODUCER IN PLACE. IT WAS FURTHER REPORTED THAT THE COIL MIGRATED AND NOT THE TIP OF THE CATHETER AS PREVIOUSLY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18662246 ↗
• MalfunctionMay 30, 2023Difficult to Insert; Difficult to Insert

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT THE COIL COULD NOT ENTER THE IMAGING CATHETER. A 15MMX40CM INTERLOCK-35 COIL WAS SELECTED FOR USE IN THE VENOUS GASTRIC FUNDUS TO TREAT ESOPHAGOGASTRIC VARICEAL BLEEDING (EGVB). DURING THE TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE, THE IMAGING CATHETER HAD ENTERED THE VEIN WITH ESOPHAGOGASTRIC VARICES (EGV), THEN THIS COIL DEVICE WAS USED BUT COULD NOT ENTER THE IMAGING 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 MAIN COIL WAS DETACHED AT THE COIL ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17019726 ↗
• InjuryMar 20, 2023Premature Activation; Malposition of Device; Premature Activation; Malposition of Device

  IT WAS REPORTED THAT COIL MIGRATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE RIGHT GONADAL VEIN. A 15MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS NOT COUPLED AND THE DEVICE WAS RELEASED PREMATURELY. CONSEQUENTLY, IT WAS NOTED THAT THE COIL WAS IN THE WRONG LOCATION. THE PROCEDURE WAS NOT COMPLETED AS INTENDED, AND THE PROCEDURE WAS CANCELLED. THE PATIENT WAS THEN ADMITTED TO ANOTHER HOSPITAL TO RETROFIT THE COIL THAT WAS IN THE WRONG LOCATION.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16576718 ↗
• MalfunctionDec 8, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11-NOV-2022. IT WAS REPORTED THAT THE COIL WAS STUCK. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A 15MM X 40CM INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON DEPLOYMENT, IT WAS NOTED THAT THE FIRST COIL GOT STUCK DISTALLY. THE CATHETER AND THE COIL WERE SIMPLY PULLED OUT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH A ANOTHER OF SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED A FIBER LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15941182 ↗
• MalfunctionNov 30, 2022Break; Break

  REPORTABLE BASED ON ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022. IT WAS REPORTED THAT COIL FRAYED. THE TARGET LESION WAS LOCATED IN THE PELVIC VARICOSE VEINS. A 15MM X 40CM INTERLOCK .035 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL IS PASSED THROUGH A 5 FR CATHETER AND FRAYED. IT WAS FURTHER CONFIRMED THAT THE DEVICE WAS DAMAGED AND DISINTEGRATED. THE COIL IS WITHDRAWN THROUGH THE CATHETER WITHOUT PROBLEM AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15890477 ↗
• MalfunctionAug 18, 2022Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27JUL2022. IT WAS REPORTED THAT THE DEVICE COULD NOT BE PUSHED. VASCULAR ACCESS WAS OBTAINED VIA THE INTERNAL ILIAC ARTERY. A 15MMX40CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS INSERTED AND EXTENDED ABOUT 10CM FROM A NON-BOSTON SCIENTIFIC CATHETER TIP. THE INTERLOCK WAS RETRACTED INSIDE THE CATHETER FOR REPOSITIONING AND WAS ADVANCED AGAIN; HOWEVER, IT COULD NOT BE PUSHED, SO IT WAS REMOVED OUTSIDE THE BODY. AS PER PHYSICIAN'S COMMENT, IT SEEMED THAT THROMBOSIS OCCURRED IN THE ANGIOGRAPHIC CATHETER AND DEVICE GOT STUCK WHEN INTERLOCK THAT CAME IN CONTACT WITH THE BLOOD AGAIN WAS RETRACTED INSIDE THE ANGIOGRAPHIC CATHETER. ONLY THE COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE INVESTIGATIONS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15254834 ↗
• MalfunctionDec 15, 2021Entrapment of Device; Premature Activation; Stretched; Physical Resistance/Sticking; Entrapment of Device; Premature Activation; Stretched; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07DEC2021. IT WAS REPORTED THAT THE COIL PREMATURELY DEPLOYED. A .035 INTERLOCK 2D 15MM X 40CM EMBOLIC COIL WAS SELECTED TO EMBOLIZE A SPLENIC ARTERY ANEURYSM. THE COIL WAS ADVANCED INTO THE MIDDLE OF THE CATHETER. THERE WAS FRICTION ADVANCING THE COIL. HOWEVER, THE COIL PREMATURELY DEPLOYED AND BECAME STRETCHED. THE COIL AND CATHETER WERE REMOVED. A NEW COIL AND CATHETER WERE USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS. HOWEVER, DEVICE ANALYSIS REVEALED A DETACHED INTERLOCKING ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13014895 ↗
• MalfunctionOct 17, 2021Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24SEP2021. IT WAS NOTED THAT THE COIL COULD NOT BE PUSHED FROM THE PROTECTION SHEATH. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 15MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, FOUR COILS WERE USED ALTOGETHER. AFTER RELEASING THE SECOND COIL, IT COULD NOT BE PUSHED FROM THE PROTECTION SHEATH AND STILL DID NOT WORK AFTER TRYING REPEATEDLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED, AND FIBER BUNDLES WERE LACKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12644441 ↗
• MalfunctionJul 8, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE TIP OF THE MICROCATHETER DURING REMOVAL. THE NON STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED INTERNAL ILIAC ARTERY. A 15MM X 40CM INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL BECAME STUCK IN THE DISTAL PART OF THE CATHETER. FURTHERMORE, WHEN THE COIL WAS REMOVED FROM THE PATIENT'S BODY, IT WAS NOTED THAT THE COIL PROTRUDED FROM THE TIP OF THE MICROCATHETER. THERE WAS RESISTANCE IN REMOVING THE COIL FROM BEING STUCK FROM THE CATHETER, HOWEVER, THE PHYSICIAN MANAGED TO REMOVE IT SAFELY. THEN, A 6MM X 20CM INTERLOCK-35 COIL WAS USED, HOWEVER, IT BECAME STUCK IN THE CATHETER AND HAD TO BE REMOVED AS A UNIT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12136173 ↗
• MalfunctionMay 3, 2021Entrapment of Device; Physical Resistance/Sticking; Entrapment of Device; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT THE COIL BECAME STUCK IN THE MIDDLE PART OF THE CATHETER. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 15MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL COULD NOT BE PUSHED FORWARD. UPON WITHDRAWAL, IT WAS NOTED THAT THE COIL BECAME STUCK IN THE MIDDLE PART OF THE CATHETER. THE COIL WAS WITHDRAWN TOGETHER WITH THE DELIVERY SYSTEM, OUT OF THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED AND FIBER BUNDLES WERE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11759199 ↗
• MalfunctionApr 29, 2021Entrapment of Device; Premature Activation; Physical Resistance/Sticking; Entrapment of Device; Premature Activation; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05APR2021. IT WAS REPORTED THAT THE COIL FAILED TO PASS, STUCK, AND PREMATURELY DETACHED. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 15MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE COIL FAILED TO PASS THE MIDDLE PART OF THE CATHETER AND WAS STUCK. SUBSEQUENTLY, THE ADVANCING WIRE WAS NOTED TO BE DETACHED FROM THE COIL. BOTH COIL AND CATHETER WERE THEN REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED AND NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11745533 ↗
• MalfunctionFeb 25, 2021Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01FEB2021. IT WAS REPORTED THAT THE COIL COULD NOT ADVANCE AND DEPLOY. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTIC ARTERY. A 15MMX40CM INTERLOCK-35 WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE ADVANCED AND DEPLOY IN THE AREA. THE COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE DEVICE HAD MISSING FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11382247 ↗
• MalfunctionFeb 10, 2021Separation Failure; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking; Separation Failure; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT THE COIL COULD NOT ADVANCE AND DEPLOY. A 15MM X 40CM INTERLOCK 35 COIL WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE ADVANCED AND DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WERE MISSING FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11306739 ↗
• MalfunctionFeb 2, 2021Separation 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 27JAN2021. IT WAS REPORTED THAT THE INTERLOCK COULD NOT BE DEPLOYED IN THE PATIENT'S BODY. A 2D 15MMX40CM INTERLOCK-35 WAS SELECTED FOR USE IN A RECURRING ABDOMINAL AORTIC DISSECTION. DURING THE PROCEDURE, THE INTERLOCK COULD NOT DELIVER AND DEPLOY IN THE PATIENT'S BODY. THE DEVICE WAS REMOVED ALL TOGETHER WITHIN THE CATHETER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED AND THERE ARE MISSING FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11267157 ↗