Interlock™ M001361930Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08714729845294), received between Dec 10, 2018 and Dec 2, 2025 — classified as 3 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (8 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 2, 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 05NOV2025. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED FROM THE CATHETER. THE TARGET LESION WAS LOCATED IN THE PULMONARY ARTERY. A 14MM X 50CM PE F-IDC COIL WAS SELECTED FOR PULMONARY EMBOLISM. DURING THE PROCEDURE, THE COIL WAS STUCK IN THE CATHETER AND COULD NOT BE PUSHED OUT OF 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 A DETACHED, BENT AND STRETCHED MAIN COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23695340 ↗
• MalfunctionNov 4, 2025Stretched; Material Protrusion/Extrusion; Stretched; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A COIL HAD STRETCHED FROM THE ANEURYSM TO THE GROIN. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A 14 MM X 50 CM INTERLOCK COIL AND DIREXION MICROCATHETER WERE SELECTED FOR ANEURYSM EMBOLIZATION. DURING THE PROCEDURE, A NON-BOSTON SCIENTIFIC (NON-BSC) MICROCATHETER WAS POSITIONED, AND A NON-BSC STENT WAS HALF-DEPLOYED. THEN, THE DIREXION MICROCATHETER WAS PLACED INTO THE ANEURYSM SAC, AND COILS WERE DEPLOYED WITHOUT ANY ISSUES. THE NON-BSC STENT WAS THEN DEPLOYED. HOWEVER, IT WAS OBSERVED THAT THE COIL HAD STRETCHED FROM THE ANEURYSM TO THE GROIN. REMOVAL OF THE BERN-TIP DIREXION MICROCATHETER PROVED DIFFICULT, POSSIBLY BECAUSE IT WAS JAILED WITHIN THE SAC ALONGSIDE THE COILS. THE PHYSICIAN HAD TO PUSH THE COIL UP INTO THE SAC WHICH WAS VERY DIFFICULT BUT ULTIMATELY SUCCESSFUL. THE NON-BSC STENT ALSO HAD TO BE PUSHED INTO THE SAC AND ANOTHER STENT PLACED ACROSS THE WIDE NECK. THE COIL MAY NOT HAVE BEEN ADVANCED FAR ENOUGH FOR PROPER DEPLOYMENT, AS VISUALIZATION OF THE TIP WAS OBSCURED BY THE COIL NEST. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PROCEDURE WAS COMPLETED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23469809 ↗
• MalfunctionOct 23, 2025Separation Failure; Material Deformation; Adverse Event Without Identified Device or Use Problem; Separation Failure; Material Deformation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26SEP2025. IT WAS REPORTED THAT THE COIL BECAME ENTANGLED AND COULD NOT BE DEPLOYED. THE PATIENT PRESENTED WITH VARICEAL IN SPLENIC UNDERWENT EMBOLIZATION WITH A 14MM X 50CM INTERLOCK COIL. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL BECAME ENTANGLED WITH THE LOCK AND DID NOT DETACH FROM THE LOCK AFTER COMING OUT OF THE MICRO CATHETER. THE DEVICE WAS RETRIEVED AFTER 2ND ATTEMPTS TO AVOID THE INCORRECT PLACEMENT OF THE COIL. 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 MAIN COIL WAS DETACHED AT THE COIL ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23371201 ↗
• MalfunctionMay 22, 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 24APR2025. IT WAS REPORTED THAT THE COIL COULD NOT ADVANCE. THE TARGET LESION WAS LOCATED IN THE SPLENIC ANEURYSM. A 14MM X 50CM INTERLOCK COIL WAS DELIVERED THROUGH NON-BOSTON SCIENTIFIC MICROCATHETER. DURING THE PROCEDURE, THE COIL COULD NOT CONTINUE TO ADVANCE AT THE DISTAL END OF THE CATHETER, AND AFTER REPEATED ATTEMPTS IT STILL COULD NOT BE RELEASED. THE DEVICE WAS REMOVED FROM THE PATIENT'S BODY, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. A TOTAL OF THREE INTERLOCK COILS WERE USED IN THE PROCEDURE. 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 THAT THE MAIN COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22073907 ↗
• InjuryJun 14, 2023Break; Stretched; Failure to Advance; Break; Stretched; Failure to Advance

  IT WAS REPORTED THAT A DEVICE SEPARATION OCCURRED. A 14MM X 50CM INTERLOCK WAS SELECTED FOR USE IN A SPLENIC ARTERY ANEURYSM EMBOLIZATION PROCEDURE. 8 INTERLOCK .018 COILS HAD BEEN PREVIOUSLY DEPLOYED WITHOUT ISSUE INTO THE SPLENIC ARTERY ANEURYSM. HOWEVER, THE LAST INTERLOCK COIL WOULD NOT FULLY DEPLOY INSIDE ANEURYSM, SO DECISION WAS MADE TO RE-SHEATH AND REMOVE COIL. HOWEVER, WHEN TRYING TO REMOVE THE COIL IT BECAME DETACHED FROM THE PUSHER WIRE. THERE WAS NO SUCCESS AFTER ATTEMPTS WERE MADE TO ADVANCE THE COIL VIA WIRE INSERTION AND FLUSHING. MOREOVER, WHEN TRYING TO REMOVE THE COIL, IT BECAME STRETCHED AND THEN BROKE. A SMALL PART OF THE COIL REMAINED IN THE SPLENIC ARTERY. AN ATTEMPT WAS PERFORMED TO REMOVE THE DETACHED COMPONENT BUT WAS UNSUCCESSFUL. ALTHOUGH IT DID RESTRICT SOME BLOOD FLOW THROUGH THE SPLENIC ARTERY, BLOOD FLOW TO SPLEEN WAS CHECKED AND CONFIRMED. THE PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS/

  Patient problems: Foreign Body In Patient

  MAUDE report 17128663 ↗
• MalfunctionFeb 20, 2023Premature Activation; Stretched; Failure to Advance; Premature Activation; Stretched; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01FEB2023. IT WAS REPORTED THAT THE MAIN COIL WAS UNABLE TO ADVANCE IN THE CATHETER, PREMATURELY DEPLOYED INSIDE PATIENT AND WAS STRETCHED. THE PATIENT WAS PUNCTURED FROM THE LEFT FEMORAL ARTERY. A 14MM X 50CM INTERLOCK WAS SELECTED FOR USE. DURING THE COURSE OF THE PROCEDURE, THERE WAS RESISTANCE IN ADVANCING THE COIL. WHEN THE CATHETER WAS WITHDRAWN, THE COIL WAS STRETCHED AND UNHOOKED, AND SEPARATED FROM THE DELIVERY WIRE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM OF THE PUSHER WIRE WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404900 ↗
• MalfunctionOct 24, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28SEP2022. IT WAS REPORTED THAT THE COIL COULD NOT BE PUSHED OUT OF THE CATHETER. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY ANEURYSM. A 14MM X 50CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS REPORTED THAT THE COIL COULD NOT BE PUSHED OUT OF THE CATHETER. THE ENTIRE CATHETER WAS REMOVED AND 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 PUSHER WIRE WAS DETACHED AT MID SOLDIER JOINT SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15663931 ↗
• MalfunctionJun 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 NON-STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND NON-CALCIFIED SPLENIC ARTERY. A 14MM X 50CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL BECAME STUCK IN THE DISTAL PART OF THE CATHETER. WHEN THE COIL WAS REMOVED FROM THE PATIENT'S BODY, IT WAS NOTED THAT THE COIL PROTRUDED FROM THE TIP OF THE MICROCATHETER. ONLY THE COIL WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14575426 ↗
• MalfunctionMay 18, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PROCEDURE WAS DISCONTINUED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS VESSEL. A 14MM X 50CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, THE DEVICE STOPPED AT THE HUB PART UPON ADVANCING AND COULD NOT BE PULLED OUT. THE DEVICE WAS PULLED OUT AND ONLY THE COIL WAS COMPLETELY REMOVED. THE PROCEDURE WAS INITIALLY DISCONTINUED AND COMPLETED AFTER BEING RESCHEDULED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14428831 ↗
• InjuryFeb 8, 2022Malposition of Device; Malposition of Device

  IT WAS REPORTED THAT COIL ENDED UP IN THE WRONG LOCATION AND REMOVED WITH SNARE. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS ILIAC VEIN. A 14MM X 50CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL ENDED UP IN THE WRONG LOCATION IN THE EXTERNAL ILIAC VEIN. THE PHYSICIAN BELIEVES THAT THE COIL MAY HAVE FLICKED OUT OF PLACEMENT DURING INSERTION USING DIREXION MICROCATHETER WHICH RESULTED IN EMERGENCY REMOVAL OF COIL USING A SNARE. THE SHEATH SIZE INSERTED INTO PATIENT WAS INCREASED SO THAT SNARE COULD REMOVE THE COIL FROM THE WRONG LOCATION AND NO ADDITIONAL COILS REQUIRED. NO FURTHER PATIENT COMPLICATION REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13484317 ↗
• InjuryNov 17, 2021Premature Activation; Migration; Premature Activation; Migration

  IT WAS REPORTED THAT A COIL MIGRATED INTO THE PERFORATED VESSEL. THE TARGET LESION WAS LOCATED IN THE SPLENO-RENAL SHUNT. A 14MM X 50CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL DEPLOYED PARTIALLY. THE PHYSICIAN TRIED TO RECAPTURE THE COIL FOR REPOSITIONING. HOWEVER, THE COIL GOT DETACHED INSIDE THE MICROCATHETER. WHEN THE PHYSICIAN ATTEMPTED TO REMOVE THE COIL, THE COIL WENT THROUGH THE PERFORATED VESSEL THAT WAS NOT THE INTENDED AREA FOR TREATMENT. THE PHYSICIAN COULD NOT SNARE THE COIL, LEAVING IT IN THE SPLENO-RENAL COLLATERAL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12832331 ↗
• MalfunctionOct 28, 2021Contamination; Material Integrity Problem; Contamination; Material Integrity Problem

  IT WAS REPORTED THAT THE DEVICE GOT CONTAMINATED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON CALCIFIED ABDOMINAL VESSEL. A 14MM X 50CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE COIL WAS TAKEN OUT FROM THE DISPENSER, THE COIL UNINTENTIONALLY CAME OUT FROM THE INTRODUCER SHEATH AND BECAME UNCLEAN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12711147 ↗
• MalfunctionSep 7, 2021Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11AUG2021. IT WAS REPORTED THAT COIL WAS STUCK INSIDE THE MICROCATHETER. THE TARGET LESION WAS LOCATED IN THE VARICOCELE AREA. A 14MM X 50CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PREPARATION, THE COIL GOT STUCK INSIDE THE MICROCATHETER. FLUSHING WAS PERFORMED CONTINUOUSLY PRIOR TO REMOVING THE ENTIRE CATHETER ASSEMBLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, THE DEVICE ANALYSIS REVEALED A BROKEN PUSHER WIRE AT THE PROXIMAL END. IT WAS FURTHER REPORTED THAT THE PUSHER WIRE WAS SEVERELY KINKED ALONG THE WIRE AND WAS BROKEN 137.16 CM AT THE DISTAL END.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12436701 ↗
• MalfunctionAug 10, 2021Separation Failure; Separation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22JUL2021. IT WAS REPORTED THAT THE DEVICE COULD NOT DEPLOY. THE TARGET LESION WAS LOCATED IN THE ABDOMEN. A 14MM X 50CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE COULD NOT DEPLOY. THE DEVICE WAS SIMPLY PULLED OUT WITH THE CATHETER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WERE MISSING FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12303072 ↗
• MalfunctionFeb 11, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER TIP. THE TARGET LESION AREA WAS LOCATED IN A SEVERELY TORTUOUS BLOOD VESSEL. A 2D 14MM X 50CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS STUCK IN THE CATHETER AT THE DISTAL PART. THE COIL WAS PULLED OUT NORMALLY. HOWEVER, UPON REMOVAL, THE COIL PROTRUDED FROM THE TIP OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11314773 ↗
• MalfunctionOct 30, 2020Break; Entrapment of Device; Material Deformation; Break; Entrapment of Device; Material Deformation

  IT WAS REPORTED THAT THE DELIVERY WIRE GOT BROKEN. THE TARGET LESION AREA WAS LOCATED IN A MODERATELY TORTUOUS RIGHT FEMORAL ARTERY. A 14MMX50CM INTERLOCK EMBOLIC WAS SELECTED FOR USE IN A COIL EMBOLIZATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE GOT STUCK INSIDE THE MICROCATHETER AND COULD NOT ADVANCE. HOWEVER, THE DELIVERY WIRE GOT BROKEN/KINKED. THE DEVICE WAS REMOVED TOGETHER WITH THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10762688 ↗
• MalfunctionSep 2, 2020Contamination; Contamination

  IT WAS REPORTED THAT THE PACKAGE WAS CONTAMINATED. A 14MMX50CM INTERLOCK COIL WAS SELECTED FOR USE ON THE LIVER. DURING PREPARATION, IT WAS NOTED THAT THE PACKAGE WAS CONTAMINATED. BOTH THE PACKAGE SEAL AND THE STERILITY OF THE DEVICE WERE COMPROMISED. THE DEVICE DID NOT ENTER THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10484172 ↗
• MalfunctionJul 10, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL BECAME STUCK IN THE CATHETER WHEN HALF OF THE DEVICE WAS DEPLOYED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED INTERNAL ILIAC ARTERY. A 14MMX50CM INTERLOCK WAS SELECTED FOR USE. DURING PROCEDURE, EMBOLIZATION WAS PERFORMED UNDER CONTINUOUS FLUSHING. HOWEVER, THE COIL GOT STUCK IN THE CATHETER WHEN HALF OF THE DEVICE WAS DEPLOYED INTO THE VESSEL. THE DEVICE WAS DIFFICULT TO PUSH AND PULL AND WAS THEN REMOVED TOGETHER WITH THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10259792 ↗
• MalfunctionMay 1, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE DEVICE GOT STUCK INSIDE THE MICROCATHETER AND PROTRUDED FROM THE TIP. THE NON-STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS INTERNAL ILIAC ARTERY. A 14MM X 50CM INTERLOCK COIL WAS SELECTED FOR USE IN A LIMB VASCULAR EMBOLIZATION. DURING THE PROCEDURE, WHEN THIS DEVICE WAS TAKEN IN AND OUT TO WOUND UP AGAIN SEVERAL TIMES IT GOT STUCK INSIDE THE DISTAL SIDE OF THE MICROCATHETER. HOWEVER, IT WAS FURTHER REPORTED THAT INTERMITTENT FLUSHING WAS PERFORMED BEFORE INTRODUCTION OF THE COIL USING HAND INJECTION. THE DEVICE WAS REMOVED TOGETHER WITH THE CATHETER. THE DISTAL SIDE OF THE COIL WAS PROTRUDING FROM THE TIP OF THE CATHETER DURING REMOVAL. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED AND PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10018215 ↗
• MalfunctionDec 27, 2019Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL WAS STUCK IN THE CATHETER'S TIP DURING REMOVAL. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 14MM X 50CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS STUCK ON THE DISTAL PART OF THE MICROCATHETER. THE DEVICE WAS REMOVED NORMALLY; HOWEVER, DURING REMOVAL, IT WAS NOTED THAT THE COIL PROTRUDED FROM THE CATHETER'S TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9527353 ↗
• MalfunctionAug 23, 2019Entrapment of Device; Retraction Problem; Entrapment of Device; Retraction Problem

  IT WAS REPORTED THAT COIL PROTRUDED FROM THE CATHETER TIP UPON REMOVAL. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS PORTAL VEIN. A 14MM X 50CM INTERLOCK COIL WAS SELECTED FOR USE AND INTERMITTENT FLUSHING WAS PERFORMED. THE COIL INTERLOCKING ARM WAS CONNECTED AND THE INTRODUCER SHEATH WAS ABLE TO RETRACT IN THE HUB WHEN INSERTING THE COIL WITH THE TWISTLOCK COMPLETELY OPENED. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL BECAME STUCK IN THE DISTAL PORTION OF THE NON-BSC MICROCATHETER. THE COIL AND MICROCATHETER WERE REMOVED TOGETHER. HOWEVER, THE COIL PROTRUDED FROM THE DISTAL TIP OF CATHETER DURING REMOVAL. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8925345 ↗
• MalfunctionDec 10, 2018Stretched; Material Integrity Problem; Stretched; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13-NOV-2018. IT WAS REPORTED THAT THE COIL DID NOT COIL UP AND BECAME ELONGATED. THE TARGET LESION WAS LOCATED IN SEVERELY TORTUOUS SPLENORENAL VEIN. DURING THE PROCEDURE, THE DEVICE WAS USED WITH A NON- BSC CATHETER. HOWEVER, IT WAS NOTED THAT THE COIL DID NOT COIL UP SUCCESSFULLY AND GOT ELONGATED WHEN IT WAS PULLED AND PUSHED. THE DEVICE WAS THEN SIMPLY PULLED OUT FROM THE PATIENT. 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 COIL WAS DETACHED AND NOT RETURNED; THERE WERE MISSING COIL FIBER BUNDLES. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. A COIL WAS RETURNED FOR THIS COMPLAINT. THE PUSHER WIRE AND THE INTRODUCER SHEATH WERE NOT RETURNED. THE COIL WAS RETURNED STRETCHED, KINKED AND THE INTERLOCKING ARM WAS DETACHED AND IT WAS NOT RETURNED. MICROSCOPIC INSPECTION OF THE MAIN COIL REVEALED THAT THE ZAP TIP HAS A SMOOTH SURFACE. THE COIL WAS STRETCHED AND KINKED. DIMENSIONAL INSPECTION OF THE COIL WAS PERFORMED AND REVEALED THAT THE OUTER DIAMETER (OD) OF THE ZAP TIP AND OD OF PRIMA

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8146583 ↗