Interlock™ M001361920Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 08714729845287), received between Nov 9, 2018 and Sep 23, 2026 — classified as 6 injuries, 25 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 23, 2026Difficult to Remove; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  Reportable based on device analysis completed on 01Sep2026.It was reported that the coil was unable to advance and withdraw from the microcatheter.A 10mm x 50cm Interlock coil was selected for use. However, during the procedure, it was noted that the coil got stuck with a non-Boston Scientific microcatheter after crossing the hub and was not able to remove. As a result, the entire catheter assembly was removed. The procedure was completed with another Interlock coil. There were no patient complications as a result of this event.However, device analysis revealed the pusher wire was detached from the Heat Shrink TFE tubing section.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50867334 ↗
• MalfunctionDec 9, 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 DEVICE UNABLE TO ADVANCE IN CATHETER AND STRETCH OCCURRED. THE TARGET LESION WAS LOCATED IN THE VESSEL IN THE ABDOMEN. A 10MM X 50CM PE F-IDC WAS SELECTED FOR USE IN A THROMBECTOMY PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK IN THE CATHETER AND AFTER ADJUSTING, THE COIL COULD NOT STILL BE DELIVERED. FLUSHING WITH HEPARINIZED SALINE WAS DONE HOWEVER WAS INEFFECTIVE. THE COIL AND THE MICROCATHETER WERE WITHDRAWN TOGETHER, IT WAS OBSERVED THAT THE COIL HAD STRETCHED. 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 A MAIN COIL DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23758492 ↗
• MalfunctionOct 16, 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 19SEP2024. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED FROM THE CATHETER. A 10MM X 50CM INTERLOCK COIL WAS SELECTED FOR ANEURYSM EMBOLIZATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE PUSHED OUT IN 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 A MAIN COIL DETACHMENT AT THE COIL ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20463144 ↗
• MalfunctionJun 13, 2024Break; Stretched; Separation Failure; Material Deformation; Break; Stretched; Separation Failure; Material Deformation

  IT WAS REPORTED THAT COIL BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED INTERNAL ILIAC ARTERY. A 10MM X 50CM INTERLOCK COIL WAS SELECTED FOR ENDOVASCULAR ANEURYSM REPAIR (EVAR). HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL BROKE INSIDE THE PATIENT'S BODY. THE COIL WAS ENTANGLED WITH A NON-BSC MICROCATHETER AND WERE REMOVED TOGETHER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19528697 ↗
• InjuryMay 29, 2024Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COIL BROKE FROM THE WIRE AND SNARING OCCURRED. THE PATIENT UNDERWENT A PULMONARY ARTERY EMBOLIZATION PROCEDURE WHERE A 10MM X 50CM INTERLOCK WAS SELECTED FOR TREATMENT. THE DEVICE WAS DEPLOYED AS PER INSTRUCTIONS. DURING THE PROCEDURE, THE COIL DID NOT DETACH FROM THE LOCK ARM/PORTION AND INSTEAD DETACHED 10 TO 12CM PROXIMAL TO THE DESIGNED LOCK ARM AND BROKE FROM THE WIRE. THE SEPARATED FRAGMENT WAS VISIBLE UNDER THE FLUOROSCOPY AND THE PHYSICIAN USED A SNARE WIRE TO CAPTURE THE COIL MATERIAL AND RETRIEVE IT IMMEDIATELY. THE COIL WAS SUCCESSFULLY REMOVED, AND THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19414817 ↗
• InjuryFeb 2, 2024Break; Stretched; Break; Stretched

  IT WAS REPORTED THAT THE COIL BROKE AND WAS PARTIALLY RECOVERED. THE TARGET LESION WAS LOCATED IN THE LEFT INTERNAL ILIAC ARTERY. A 10MM X 50CM INTERLOCK WAS SELECTED FOR EMBOLIZATION OF THE SUPERIOR AND INFERIOR GLUTEAL ARTERY. THE COIL WAS SUCCESSFULLY IMPLANTED IN THE LEFT INTERNAL ILIAC ARTERY. UPON REMOVAL OF THE MICROCATHETER, IT WAS NOTED THAT THERE WAS A MARKER-LIKE OBJECT OBSERVED IN THE NON-BOSTON SCIENTIFIC GUIDE CATHETER NEAR THE ENTRANCE AREA. THE COIL WAS CONSIDERED TO HAVE BEEN STRETCHED; THEREFORE, THE COIL WAS RECOVERED. DURING IMAGING, TWO MARKER-LIKE OBJECTS WERE OBSERVED. THE COIL WAS SLOWLY PULLED OUT AND THE MARKER-LIKE OBJECT DISAPPEARED. THE PROCEDURE WAS COMPLETED WITH ANOTHER RENEGADE WITH THE SAME SPECS. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18634630 ↗
• 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 A 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 18268468 ↗
• MalfunctionApr 1, 2022Difficult to Insert; Difficult to Insert

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT THE COIL COULD NOT BE INSERTED INTO THE CATHETER THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED ILIAC ARTERY. A 10MM X 50CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE INSERTED INTO THE CATHETER SO IT WAS REMOVED. THE PHYSICIAN TRIED TO REINSERT THE COIL, HOWEVER RESISTANCE WAS FELT ABOUT 3CM BEFORE REACHING THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WERE MISSING FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13978221 ↗
• MalfunctionFeb 16, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM CATHETER. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED INTERNAL ILIAC ARTERY. A 10MM X 50CM 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 THE CATHETER. THE COIL PROTRUDED FROM THE TIP OF THE CATHETER UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13543811 ↗
• MalfunctionJan 19, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL GOT STUCK IN THE MICROCATHETER TIP. VASCULAR ACCESS WAS OBTAINED VIA CONTRALATERAL APPROACH. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MILDLY CALCIFIED INTERNAL ILIAC ARTERY. A 10MM X 50CM PE F-IDC INTERLOCK EMBOLICS WAS SELECTED FOR USE. DURING THE PROCEDURE, A TOTAL OF EIGHT COILS WERE USED, HOWEVER, THE SIXTH COIL GOT STUCK IN THE MICROCATHETER AND IT WAS ABOUT 5CM BEFORE THE TIP OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13296297 ↗
• MalfunctionDec 3, 2021Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09NOV2021. IT WAS REPORTED THAT THE COIL WAS STUCK. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A 10MM X 50CM INTERLOCK WAS SELECTED FOR USE FOR THE EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK IN THE DELIVERY MICROCATHETER (.028 INNER DIAMETER). THE PROCEDURE WAS COMPLETED WITH A NON-BSC COIL. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE ZAP TIP AND INTERLOCKING ARM WERE DETACHED, AND THE FIBER BUNDLES WERE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12922909 ↗
• MalfunctionOct 27, 2021Device-Device Incompatibility; Device-Device Incompatibility

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07OCT2021. IT WAS REPORTED THAT THE COIL DETACHED IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 10MM X 50CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, THE CATHETER AND HUB PART OF THE DIREXION CATHETER BROKE WHEN THE COIL WAS INSERTED. BOTH THE COIL AND CATHETER WERE REMOVED WITHOUT ANY PROBLEMS. HOWEVER, THE COIL PREMATURELY DETACHED INTO THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM DETACHED AND FIBER BUNDLES WERE LACKING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12708354 ↗
• MalfunctionOct 26, 2021Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07OCT2021. IT WAS REPORTED THAT RESISTANCE WAS FELT IN THE DISPENSER. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED SUBCLAVIAN ARTERY. A 10MM X 50CM INTERLOCK 2D WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT RESISTANCE WAS FELT IN THE DISPENSER. 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 AND THERE WERE MISSING FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12697539 ↗
• MalfunctionOct 13, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22SEP2021. IT WAS REPORTED THAT THE DEVICE COULD NOT BE DELIVERED. THE TARGET LESION WAS LOCATED IN THE ABDOMEN AREA. A 10MM X 50CM INTERLOCK COIL WERE SELECTED FOR USE. DURING THE PROCEDURE, AFTER THE FIRST RING WAS DETACHED, IT WAS NOTED THAT THE MICROCATHETER COULD NOT BE DELIVERED. THE DEVICE WAS DEPLOYED SUCCESSFULLY AFTER REPLACING THE COIL WITH ANOTHER OF THE SAME DEVICE. THE SAME PROBLEM OCCURRED WITH THE TWO DEVICES DURING THE OPERATION. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE FIBER BUNDLES WERE INCOMPLETE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12624969 ↗
• MalfunctionJul 1, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER'S TIP DURING REMOVAL. THE NON STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON CALCIFIED INTERNAL ILIAC ARTERY. A 10MMX30CM AND A 10MMX50CM INTERLOCK COIL WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL BECAME STUCK IN THE DISTAL PART OF THE CATHETER. FURTHERMORE, WHEN THE COILS WERE REMOVED FROM THE PATIENT'S BODY, IT WAS NOTED THAT THE DEVICES PROTRUDED FROM THE TIP OF THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12101065 ↗
• InjuryJul 1, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER'S TIP DURING REMOVAL AND THROMBOSIS HAS PROGRESSED. THE NON STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NOT SEVERELY CALCIFIED INTERNAL ILIAC ARTERY. TWO 10MM X 50CM INTERLOCK COILS WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT BOTH COILS BECAME STUCK IN THE DISTAL PART OF THE CATHETER. FURTHERMORE, WHEN THE COILS WERE REMOVED FROM THE PATIENT'S BODY, IT WAS NOTED THAT THE DEVICES PROTRUDED FROM THE TIP OF THE MICROCATHETER. PHYSICIAN'S COMMENT WAS THAT THROMBOSIS PROGRESSED WHILE COIL WAS INSERTED AND REMOVED TO ADJUST THE SHAPE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12100913 ↗
• InjuryJul 1, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER'S TIP DURING REMOVAL AND THROMBOSIS HAS PROGRESSED. THE NON STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NOT SEVERELY CALCIFIED INTERNAL ILIAC ARTERY. TWO 10MM X 50CM INTERLOCK COILS WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT BOTH COILS BECAME STUCK IN THE DISTAL PART OF THE CATHETER. FURTHERMORE, WHEN THE COILS WERE REMOVED FROM THE PATIENT'S BODY, IT WAS NOTED THAT THE DEVICES PROTRUDED FROM THE TIP OF THE MICROCATHETER. PHYSICIAN'S COMMENT WAS THAT THROMBOSIS PROGRESSED WHILE COIL WAS INSERTED AND REMOVED TO ADJUST THE SHAPE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 12100902 ↗
• MalfunctionApr 27, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM CATHETER TIP UPON REMOVAL. THE TARGET LESION AREA WAS LOCATED IN THE MODERATELY TORTUOUS INTERNAL ILIAC ARTERY. A 10MMX50CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK INSIDE THE DISTAL PART OF THE CATHETER. THE COIL AND CATHETER WERE REMOVED TOGETHER. SUBSEQUENTLY, THE COIL PROTRUDED FROM CATHETER'S TIP UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11732521 ↗
• MalfunctionMar 26, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT COIL PROTRUDED UPON REMOVAL. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 10MM X 50CM INTERLOCK WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK IN THE DISTAL PART OF THE CATHETER. THE COIL AND CATHETER WERE THEN REMOVED TOGETHER, HOWEVER THE COIL WAS NOTED PROTRUDING FROM THE CATHETER'S TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11574660 ↗
• MalfunctionFeb 3, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED IN THE CATHETER. A 10MMX50CM 2D INTERLOCK COIL WAS SELECTED FOR USE. DURING PROCEDURE, THE COIL BECAME STUCK IN THE DISTAL PART OF THE CATHETER. WHEN IT WAS PULLED OUT FROM THE PATIENT'S BODY, IT WAS NOTED THAT THE COIL PROTRUDED FROM THE TIP OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11273273 ↗
• MalfunctionDec 29, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED IN THE CATHETER'S TIP DURING REMOVAL. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED INTERNAL ILIAC ARTERY. A 10MMX50CM 2D INTERLOCK 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 CATHETER. THE COIL WAS PULLED OUT FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11089482 ↗
• MalfunctionNov 30, 2020Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16NOV2020. IT WAS REPORTED THAT THE COIL WAS STUCK IN THE CATHETER. A 10MMX50CM INTERLOCK COIL WAS SELECTED FOR USE ON THE INTERNAL ILIAC ARTERY. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS STUCK IN THE CATHETER DISTAL PART. THE COIL WAS REMOVED WITH THE CATHETER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THERE WAS NO PATIENT INJURY. HOWEVER, DEVICE ANALYSIS REVEALED AN INTERLOCKING ARM DETACHED FROM THE REST OF THE COIL AND PUSHER WIRE, AND FIBER LOSS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10920346 ↗
• MalfunctionSep 28, 2020Entrapment 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 LEFT INTERNAL ILIAC ARTERY. A 10MMX50CM INTERLOCK COIL WAS SELECTED FOR USE. DURING 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. THE COIL WAS REMOVED TOGETHER WITH THE CATHETER AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10593733 ↗
• MalfunctionSep 25, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER TIP. THE TARGET LESION AREA WAS LOCATED IN THE LEFT INTERNAL ILIAC ARTERY. A 10MM X 50CM INTERLOCK PE F-IDC EMBOLIC WAS SELECTED FOR USE IN A SHAFT GRAFT PLACEMENT. DURING THE PROCEDURE, THE DEVICE GOT STUCK INSIDE THE DISTAL PART OF THE MICROCATHETER. HOWEVER, WHEN THE COIL WAS REMOVED, THE COIL PROTRUDED FROM THE TIP OF THE CATHETER. THE COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER BY THE USE OF A SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10587372 ↗
• MalfunctionJun 10, 2020Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26MAY2020. IT WAS REPORTED THAT THE COIL COULD NOT BE WITHDRAWN FROM THE CATHETER. A TARGET LESION WAS LOCATED AT THE FUNDUS OF STOMACH. A 10MM X 50CM INTERLOCK COIL WAS SELECTED FOR USE IN GASTRIC FUNDUS FOR VEIN BLEEDING. DURING PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE PUSHED OR WITHDREW WHEN THE MICROCATHETER WAS ADVANCED. HOWEVER, IT WAS FURTHER REPORTED THAT CONTINUOUS FLUSHING WAS PERFORMED. SUBSEQUENTLY, THE COIL WAS REMOVED WITH THE CATHETER FROM THE PATIENT WITHOUT ANY INTERVENTION. THE BSC MICROCATHETER USED HAS NO ISSUE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED INTERLOCKING ARM DETACHED AND MISSING FIBER BUNDLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10138660 ↗