Interlock™ M001361580Recalls & reported problems

Summary

The FDA's MAUDE database contains 35 adverse event reports that list this exact device (DI 08714729765011), received between Feb 18, 2020 and Nov 18, 2025 — classified as 4 injuries, 31 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (17 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 35 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 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 DEVICE ANALYSIS COMPLETED ON 21OCT2025. IT WAS REPORTED THAT COIL UNABLE TO WITHDRAW OCCURRED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERY. AN 8MM X 20CM F-IDC 2D WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK AND AFTER MULTIPLE ATTEMPTS, THE COIL STILL COULD NOT BE DEPLOYED. THE PROCEDURE WAS COMPLETED WIN ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED AN INTRODUCER SHEATH DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23582983 ↗
• MalfunctionMar 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 16FEB2025. IT WAS REPORTED THAT THE COIL COULD NOT ADVANCE IN THE CATHETER. AN 8MM X 20CM INTERLOCK COIL WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THE COIL COULD NOT ADVANCE IN THE CATHETER. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A PUSHER WIRE DETACHMENT AT THE COIL SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599023 ↗
• MalfunctionMar 11, 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 THE DEVICE ANALYSIS COMPLETED ON 14FEB2025. IT WAS REPORTED THAT THE COIL WAS STRETCHED AND WAS UNABLE TO ADVANCE IN CATHETER. A 8MM X 20CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE PHYSICIAN ATTEMPTED TO DEPLOY THE COIL BUT ENCOUNTERED DIFFICULTY ADVANCING IT. AFTER RESHEATHING AND FLUSHING THE CATHETER, ADVANCEMENT REMAINED UNSUCCESSFUL. UPON REMOVAL, THE COIL WAS STILL ATTACHED BUT HAD UNRAVELED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21576959 ↗
• InjuryNov 5, 2024Entrapment of Device; Difficult to Remove; Stretched; Failure to Advance; Malposition of Device; Entrapment of Device; Difficult to Remove; Stretched; Failure to Advance; Malposition of Device

  IT WAS REPORTED THAT THE DEVICE GOT STUCK IN THE MICROCATHETER AND REQUIRING ADDITIONAL INTERVENTION. THE HEMOSTASIS OF RIGHT INTERNAL ILIAC HEMORRHAGE HAS BEEN ACHIEVED WITH COIL EMBOLIZATION VIA LEFT FEMORAL APPROACH. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED RIGHT INTERNAL ILIAC. A 6MM X 20CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL GOT STUCK AT THE TIP OF A NON - BOSTON SCIENTIFIC MICROCATHETER AND WAS UNRAVELED WHEN PULLED. THE MICROCATHETER WAS REMOVED AND LEFT THE COIL IN THE NON - BOSTON SCIENTIFIC GUIDING CATHETER. THE REMAINING COIL WAS PUSHED WITH THE SHEATH DILATOR; HOWEVER, IT DID NOT MOVE. EVENTUALLY, THE GROIN WAS INCISED, AND THE COIL WAS CUT PARTWAY THROUGH, AND THE REMAINDER WAS LEFT IN THE BODY. THE REMAINING PART WAS LEFT IN AN UNINTENDED LOCATION. THE MICROCATHETER WAS REPLACED WITH ANOTHER OF THE SAME DEVICE AND AN 8MM X 20CM INTERLOCK WAS PLACED AGAIN, BUT THE SAME ISSUE OCCURRED. THE USER TRIED LEAVING THE COIL IN THE DESTINATION AND PUSHING IT WITH THE SHEATH DILATOR, BUT THIS WAS NOT POSSIBLE. THE SYSTEM WAS REMOVED, AND THE REMAINING COIL WAS CUT THROUGH AN INCISION IN THE INGUINAL REGION. THE CUT PAR

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

  MAUDE report 20615076 ↗
• MalfunctionSep 17, 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 20AUG2024. THE TARGET LESION WAS LOCATED IN THE COMMON HEPATIC ARTERY. AN 8MM X 20CM INTERLOCK COIL WAS SELECTED FOR EMBOLIZATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE PUSHED OUT OF THE CATHETER WHEN BEING DELIVERED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED ZAP TIP AND ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20239621 ↗
• InjurySep 3, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SNARE WAS USED TO RETRIEVE A DEVICE FRAGMENT. THE TARGET LESION WAS LOCATED IN THE LOWER LIMB ANTERIOR ARTERY ANEURYSM. THE MICROCATHETER WAS ADVANCED AND REACH THE MAIN TRUNK, THE HEPARIN SALINE WAS MANUALLY INJECTED, AND THE 8MM X 20CM 2D INTERLOCK COIL WAS ADVANCED AND RELEASED SMOOTHLY. UPON REMOVING THE DELIVERY WIRE, IT WAS FOUND THAT THERE WAS A SMALL BAND WIRE IN THE MICROCATHETER UNDER THE TRANSMISSION. THE LENGTH WAS FROM THE OPENING OF THE ANTERIOR RADIAL ARTERY TO THE MIDDLE SEGMENT OF THE SUPERFICIAL FEMORAL ARTERY. THE PHYSICIAN WITHDREW THE MICROCATHETER BY USING A SNARE TO CATCH THE BAND WIRE AND PULLED IT OUT FROM THE PATIENT. BECAUSE OF THE OPERATION TIME TOOK TOO LONG, SPASMS AND THROMBOSIS OCCURRED IN THE POPLITEAL ARTERY. BECAUSE OF THE REPEATED ATTEMPTS TO PULL THE COIL OUT WITH THE SNARE, THE CATHETER IRRITATES THE LINING OF THE BLOOD VESSEL CAUSING SPASM AND THROMBOSIS. THE THROMBUS WAS EXTRACTED BY A 6F GUIDE CATHETER WITH A SYRINGE. THE PATIENT WAS GIVEN UROKINASE AND PAPAVERINE, AND THE BLOOD FLOW IN THE POPLITEAL ARTERY WAS RECOVERED. THE ANTERIOR RADIAL ARTERY HAS NO BLOOD FLOW, AND THE ANEURYSM WAS NOT VISIBLE ON IMAGING. THE PRO

  Patient problems: Thrombosis/Thrombus; Vasoconstriction

  MAUDE report 20128316 ↗
• MalfunctionJul 24, 2024Failure to Advance; Separation Failure; Failure to Advance; Separation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24JUN2024. IT WAS REPORTED THAT THE COIL WAS UNABLE TO ADVANCE IN CATHETER AND FAILED TO SEPARATE. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. AN 8MM X 20CM INTERLOCK WAS USED DURING EMBOLIZATION; HOWEVER, DURING THE PROCEDURE, THE THIRD AND FOURTH COILS COULD NOT BE PUSHED NORMALLY DESPITE MULTIPLE ATTEMPTS. AT THE SAME TIME, CONTINUOUS INFUSION OF HEPARIN SALINE WAS PERFORMED, AND THE COIL WAS WITHDRAWN AND RE-ADVANCED, BUT THE COIL WOULD NOT DETACH. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19817448 ↗
• MalfunctionJun 20, 2024Difficult to Remove; Stretched; Material Integrity Problem; Difficult to Remove; Stretched; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24MAY2024. IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO COIL-UP, DIFFICULT TO RETRACT INTO THE SHEATH, AND WAS STRETCHED. THE PATIENT PRESENTED WITH CHIROBRACHIALGIA AND WAS ADMITTED TO THE HOSPITAL WITH ARTERIOVENOUS FISTULA (AVF). AFTER LOCATING THE AVF BY ANGIOGRAPHY CATHETER, AN 8MM X 20CM INTERLOCK WAS EMBOLIZED WITH A TORSIONAL MICROCATHETER. HOWEVER, BECAUSE THE VESSEL WAS RELATIVELY THIN, THE COIL WAS NOT EASY TO BE WOUNDED UP, AND WAS DIFFICULT TO PULL AND RETRACT INTO THE SHEATH WHICH CAUSED THE COIL TO BE STRETCHED. THE MICROCATHETER WAS WITHDRAWN, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A DETACHED ARM COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19578417 ↗
• MalfunctionFeb 19, 2024Entrapment of Device; Stretched; Failure to Advance; Entrapment of Device; Stretched; Failure to Advance

  IT WAS REPORTED THAT PART OF THE COIL PROTRUDED FROM CATHETER TIP UPON REMOVAL. THE TARGET LESION WAS IN THE ARTERIOVENOUS FISTULA. A 8MM X 20CM PE F-IDC INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS PUSHED INTO THE MICROCATHETER, A GREAT RESISTANCE WAS FELT. THE COIL COULD NOT BE PUSHED OUT AFTER BEING PUSHED HALFWAY. AFTER REPEATED ATTEMPTS, IT STILL COULD NOT BE PUSHED OUT INTO THE DISTAL OF THE CATHETER. THE DEVICE WAS REMOVED FROM THE PATIENT TOGETHER WITH THE CATHETER WITH PART OF THE COIL PROTRUDING FROM THE CATHETER TIP. IT WAS ALSO FOUND THAT THE COIL HAD BEEN STRETCHED UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT WAS IN STABLE CONDITION AFTER PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18732259 ↗
• MalfunctionDec 7, 2023Stretched; Failure to Advance; Stretched; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13NOV2023. IT WAS REPORTED THAT THERE WAS OBVIOUS RESISTANCE, AND THE COIL COULD NO LONGER BE PUSHED AFTER ABOUT HALF OF ITS RELEASE. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. AN 8MM X 20CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS OBVIOUS RESISTANCE, AND THE COIL COULD NO LONGER BE PUSHED AFTER ABOUT 1/2 OF ITS RELEASE. 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 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 18284044 ↗
• MalfunctionNov 29, 2023Failure to Advance; Failure to Advance

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 07NOV2023. IT WAS REPORTED THAT THE COIL WAS STUCK IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. AN 8MM X 20CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS ADVANCED INSIDE STC18 MICROCATHETER, HOWEVER THE POSITION WAS NOT GOOD, AND THE DEVICE COULD NOT BE DEPLOYED. AFTER ADJUSTMENT, THE DEVICE WAS DEPLOYED AGAIN, BUT THE COIL WAS STUCK IN THE CATHETER AND COULD NOT BE PUSHED OUT. 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 PUSHER WIRE DETACHED AT THE DISTAL SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18230738 ↗
• InjurySep 26, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE COIL WAS REMOVED BY A SNARE. THE STENOSED TARGET LESION WAS LOCATED IN THE INTRA-ILIAC VEINS. AN 8MM X 20CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE COIL WAS DEPLOYED AND REACHED THE LESION SITE, IT WAS FOUND THAT THE COIL COULD NOT BE COILED AND CONTROLLED FOR MANY ATTEMPTS. THE COIL WAS REMOVED BY A SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER INTERLOCK. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17820619 ↗
• MalfunctionSep 6, 2023Failure 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 15AUG2023. IT WAS REPORTED THAT THE COIL WAS STUCK INSIDE THE CATHETER. AN 8MM X 20CM 2D INTERLOCK COIL WAS SELECTED FOR EMBOLIZATION OF SPLENIC ANEURYSM. DURING THE PROCEDURE, A NON-BOSTON SCIENTIFIC MICROCATHETER WAS USED TO DEPLOY FOUR BSC COILS. HOWEVER, WHEN THE THIRD ONE WAS BEING DEPLOYED, IT WAS NOTED THAT THE COIL WAS STUCK INSIDE THE CATHETER. AFTER REMOVAL OF THE DEVICE, 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 17695907 ↗
• MalfunctionJul 18, 2023Failure 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) 2023. IT WAS REPORTED THAT ADVANCING DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A 8MM X 20CM F-IDC 2D COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS ADVANCED INTO THE MIDDLE PART OF THE DELIVERY SYSTEM BUT COULD NO LONGER BE ADVANCED. THE COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A DETACHED COIL AT THE ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17343637 ↗
• MalfunctionJun 1, 2023Break; Difficult to Advance; Material Integrity Problem; Break; Difficult to Advance; Material Integrity Problem

  IT WAS REPORTED THAT THE DELIVERY WIRE FRACTURED. AN 8MM X 20CM INTERLOCK WAS SELECTED FOR EMBOLIZATION OF A RENAL ARTERY ANEURYSM. DURING THE PROCEDURE, THE COIL WAS ADVANCED, BUT THE DELIVERY WIRE FRACTURED, AND THE TIP OF THE COIL WAS DEFORMED WHEN PULLED OUT. AFTER ANOTHER ONE OF THE SAME MODELS WAS USED, IT WAS SUCCESSFULLY DELIVERED. SUBSEQUENTLY, 6X20 AND 5X15 WERE USED SUCCESSIVELY FOR TAMPONADE, WHICH WAS SATISFACTORY AFTER ANGIOGRAPHY. THEN THE ANGIOGRAPHY CATHETER WAS USED TO SUPERSELECT ANOTHER TUMOR. 10X40 INTERLOCK-35 WAS USED FOR TAMPONADE FIRST, AND THEN TWO 8X20. AFTER THE IMAGE WAS SHOWN, IT WAS ALMOST SATISFACTORY. FINALLY, CATHETER WAS SELECTED INTO TUMOR CAVITY AND 4X15 INTERLOCK-18 WAS USED FOR FINAL TAMPONADE, AND THE PROCEDURE WAS COMPLETED. NO COMPLICATIONS REPORTED, AND PATIENT WAS STABLE FOLLOWING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17039323 ↗
• InjuryMay 9, 2023Stretched; Failure to Advance; Stretched; Failure to Advance

  IT WAS REPORTED THAT THE STRETCHED COIL REMAINED INSIDE THE BODY. AN 8MM X 20CM INTERLOCK COIL WAS SELECTED FOR USE IN THE RIGHT RENAL ANEURYSM. DURING THE PROCEDURE, RENAL ANEURYSM EMBOLIZATION WAS PERFORMED WITH INTERLOCK COILS, DELIVERED BY A MICROCATHETER, AND HEPARIN SALINE PERFUSION WAS PERFORMED. HOWEVER, THERE WAS OBVIOUS RESISTANCE WHEN THE COIL WAS ADVANCED INTO THE CATHETER, AND IT COULD NOT CONTINUE TO BE ADVANCED AT 2-3CM OF THE CATHETER. AFTER THE CATHETER WAS WITHDRAWN, IT WAS FOUND THAT COIL WAS STRETCHED, AND THE STRETCHED PART REMAINED IN THE PATIENT AND COULD NOT BE TAKEN OUT. THE PHYSICIAN TRIED TO WITHDRAW IT WITH A SNARE, BUT IT FAILED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16895788 ↗
• MalfunctionJan 6, 2023Difficult to Remove; Stretched; Failure to Advance; Difficult to Remove; Stretched; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT THE COIL WAS STUCK AND STRETCHED WHEN IT WAS WITHDRAWN. THE TARGET LESION WAS LOCATED IN THE AORTA ABDOMINALIS. AN 8MM X 20CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, AFTER THE MICROCATHETER AND GUIDEWIRE WERE USED TO SUPERSELECT THE DISTAL END IN PLACE, THE EIGHTH COIL WAS POSITIONED. HOWEVER, IT GOT STUCK AND COULD NOT FORWARD OR BACKWARD. SUBSEQUENTLY, THE COIL WAS WITHDRAWN WITH THE MICROCATHETER OUT OF THE PATIENT'S BODY. IT WAS FURTHER NOTED THAT THE COIL WAS STUCK IN THE EXPORT OF THE MICROCATHETER, WHICH STRETCHED SERIOUSLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16114086 ↗
• MalfunctionDec 19, 2022Premature Activation; Stretched; Premature Activation; Stretched

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT THE COIL BECAME UNRAVELED AND PREMATURELY DETACHED WITHIN THE Y-CONNECTOR. AN 8MMX20CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE COIL WAS WITHDRAWN, IT WAS NOTED THE COIL WAS UNRAVELED AND HAD PREMATURELY DETACHED WITHIN THE Y CONNECTOR. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM OF THE MAIN COIL WAS DETACHED FROM THE COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16004528 ↗
• MalfunctionSep 2, 2022Entrapment of Device; Failure to Advance; Entrapment of Device; Failure to Advance

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER'S TIP DURING REMOVAL. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS INTERNAL ILIAC ARTERY. AN 8MMX20CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL BECAME STUCK IN THE DISTAL PART OF THE CATHETER. FURTHERMORE, THE COIL PROTRUDED FROM THE TIP OF THE MICROCATHETER WHEN IT WAS REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15347238 ↗
• MalfunctionJul 27, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER'S TIP DURING REMOVAL. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED INTERNAL ILIAC ARTERY. AN 8MMX20CM INTERLOCK COIL WAS SELECTED FOR USE. INTERMITTENT FLUSHING WAS PERFORMED DURING THE PROCEDURE. DURING THE PROCEDURE, THE COIL BECAME STUCK IN THE DISTAL PART OF THE CATHETER. THE COIL WAS THEN REMOVED FROM THE PATIENT'S BODY ALONG WITH THE CATHETER. HOWEVER, IT WAS NOTED THAT THE COIL PROTRUDED FROM THE CATHETER'S TIP UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15112046 ↗
• MalfunctionJun 29, 2022Entrapment of Device; Difficult to Remove; Failure to Advance; Entrapment of Device; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER TIP UPON REMOVAL. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS INFERIOR MESENTERIC ARTERY. AN 8MM X 20CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS STUCK INSIDE THE DISTAL PART OF THE CATHETER AND WAS REMOVED TOGETHER WITH THE CATHETER. HOWEVER, IT WAS NOTED THAT THE COIL PROTRUDED FROM THE CATHETER TIP UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14854881 ↗
• MalfunctionMay 9, 2022Failure to Advance; Material Integrity Problem; Failure to Advance; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18APR2022. IT WAS REPORTED THAT THE COIL COULD NOT BE DELIVERED AND THE DELIVERY SHAFT GOT TWISTED. THE TARGET LESION WAS LOCATED IN THE CORONARY VEIN OF THE STOMACH. AN 8MM X 20CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL COULD NOT ADVANCE IN THE MIDDLE PART OF THE CATHETER. SUBSEQUENTLY, THE PHYSICIAN TRIED PULLING IT BACKWARD FOR SEVERAL TIMES BUT THE DELIVERY SHAFT GOT TWISTED. THE DEVICE WAS SIMPLY PULLED OUT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14340780 ↗
• MalfunctionMay 5, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13APR2022. IT WAS REPORTED THAT THE COIL COULD NOT BE DELIVERED AND WAS STRETCHED. THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY. A 8MMX20CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, A MICROCATHETER WAS USED TO DEPLOY A 10MMX20CM AND A 8MMX20CM 18-COIL AND BOTH WERE DEPLOYED NORMALLY. HOWEVER, WHEN THE 8X20CM 18-COIL WAS DEPLOYED, IT COULD NOT BE DELIVERED FROM THE CATHETER. AFTER REPEATED ATTEMPTS, THE COIL WAS PULLED OUT AND WAS FOUND STRETCHED AND DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WERE MISSING FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14293773 ↗
• MalfunctionFeb 28, 2022Entrapment of Device; Difficult to Remove; Failure to Advance; Entrapment of Device; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM CATHETER TIP UPON REMOVAL. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS INTERNAL ILIAC ARTERY. A 8MMX20CM PE F-IDC INTERLOCK EMBOLICS WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK IN THE DISTAL PART OF A NON-BOSTON SCIENTIFIC CATHETER AND WHEN REMOVED TOGETHER WITH THE CATHETER, PROTRUSION OF THE COIL WAS OBSERVED FROM THE TIP OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE DEVICE. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13623298 ↗
• MalfunctionNov 2, 2021Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 08OCT2021. IT WAS REPORTED THAT THE COIL BECAME STUCK IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTA. AN 8MM X 20CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE DELIVERED OUT AND WAS STUCK IN THE MIDDLE OF THE CATHETER. AFTER REPEATED ATTEMPTS, THE PHYSICIAN SLOWLY PULLED THE DEVICE BACKWARD, AND FOUND THAT IT WAS STRETCHED. THE DEVICE WAS THEN REPLACED WITH ANOTHER INTERLOCK, HOWEVER, THE COIL STILL COULD NOT BE DELIVERED. THE PROCEDURE WAS CONTINUED AFTER THE DEVICE WAS WITHDRAWN AGAIN. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE. HOWEVER, DEVICE INVESTIGATIONS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED AND THE PUSHER WIRE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12740825 ↗