Interlock™ M001361960Recalls & reported problems

Summary

The FDA's MAUDE database contains 44 adverse event reports that list this exact device (DI 08714729845324), received between Sep 18, 2018 and Dec 12, 2025 — classified as 2 injuries, 42 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 44 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 12, 2025Failure to Advance; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19NOV2025. IT WAS REPORTED THAT COIL WAS DIFFICULT AND UNABLE TO ADVANCE IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE LIVER. A 22MM X 60CM INTERLOCK COIL WAS SELECTED FOR USE. HOWEVER, WHEN THE PHYSICIAN ADVANCED THE COIL DURING THE PROCEDURE, IT FELT THAT THE RESISTANCE WAS LARGE, THE COIL COULD NOT BE PUSHED OUT OF THE CATHETER, AND THE COIL WAS STUCK. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE 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 23790961 ↗
• MalfunctionAug 19, 2025Failure to Advance; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24JUL2025. IT WAS REPORTED THAT COIL ADVANCING ISSUE OCCURRED. A 22MM X 60CM INTERLOCK COIL WAS SELECTED FOR EMBOLIZATION OF RIGHT ABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE PUSHED FORWARD. AFTER SEVERAL ATTEMPTS FAILED, THE INTERLOCKING ARM OF THE CONTROLLABLE RING WAS DAMAGED. 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 PUSHER WIRE WAS DETACHED AT THE COIL SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22841419 ↗
• MalfunctionJun 12, 2025Separation Failure; Separation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 16MAY2025. IT WAS REPORTED THAT THE COIL COULD NOT BE DEPLOYED. A 22MM X 60CM 2D INTERLOCK COIL WAS DELIVERED THROUGH STC MICROCATHETER FOR SPLENIC ANEURYSM PROCEDURE. HOWEVER, THE COIL COULD NOT BE COMPLETELY DEPLOYED. THE PHYSICIAN TRIED TO WITHDRAW AND DEPLOY IT AGAIN FOR MANY ATTEMPTS, BUT STILL COULD NOT BE DEPLOYED. THE HEPARIN SALINE WAS DRIPPED CONTINUOUSLY, AND THEN THE PROCEDURE WAS COMPLETED WITH A DIFFERENT COIL. 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 PUSHER WIRE WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22196983 ↗
• MalfunctionMay 27, 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 30APR2025. IT WAS REPORTED THAT COIL WAS UNABLE TO ADVANCE IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE NON-TORTUOUS LEFT PULMONARY ARTERY. A 22MM X 60CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS FLUSHED CONTINUOUSLY WITH A SALINE. WHILE ADVANCING THE COIL THROUGH A NON-BOSTON SCIENTIFIC MICROCATHETER, THE COIL BECAME STUCK HALFWAY IN THE MICROCATHETER AND COULD NOT BE ADVANCED FURTHER DESPITE MULTIPLE MANEUVERS. THE WHOLE SYSTEM WAS REMOVED, AND 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 ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22090578 ↗
• MalfunctionJan 17, 2025Failure to Advance; Material Deformation; Failure to Advance; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25DEC2024. IT WAS REPORTED THAT THE COIL DELIVERY SHAFT WAS BENT, AND IT COULD NOT BE PUSHED INTO THE MICROCATHETER. A 22MM X 60CM INTERLOCK COIL WAS SELECTED FOR INTERVENTIONAL EMBOLIZATION OF ARTERIOVENOUS MALFORMATION. AFTER THE PACKAGE WAS OPENED DURING THE PROCEDURE, THE COIL DELIVERY SHAFT WAS OBVIOUSLY BENT. THE COIL WAS PUSHED INTO THE MIDDLE OF THE CATHETER; HOWEVER, COULD NOT BE PUSHED ANY FURTHER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THE PUSHER WIRE WAS BENT AND DETACHED AT HEAT SHRINK TFE TUBING SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21183706 ↗
• MalfunctionDec 3, 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 (B)(6) 2024. IT WAS REPORTED THAT THE COIL COULD NOT ADVANCE THE CATHETER. THE PATIENT PRESENTED WITH ABDOMINAL AORTIC ANEURYSM UNDERWENT INTERNAL ILIAC EMBOLIZATION. A 22MM X 60CM INTERLOCK COIL WAS SELECTED FOR USE. HOWEVER, DURING THE DELIVERY PROCESS, IT WAS NOTED THAT THE COIL WAS STUCK IN THE MICROCATHETER AND COULD NOT BE PUSHED OUT AFTER MANY ATTEMPTS. THE COIL WAS WITHDRAWN, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED AN ARM COIL DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20835551 ↗
• MalfunctionOct 3, 2024Stretched; Failure to Advance; Stretched; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11SEP2024. IT WAS REPORTED THAT AN ADVANCING ISSUE OCCURRED. A 22MM X 60CM INTERLOCK COIL WAS SELECTED FOR USE IN THE EMBOLIZATION OF A SPLENIC ANEURYSM. A RENEGADE STC 18 MICROCATHETER WAS USED; HOWEVER, THE COIL COULD NOT COMPLETELY BE PUSHED OUT OF THE PROTECTIVE SHEATH. HALF OF THE COIL WAS IN THE MICROCATHETER, AND THE OTHER HALF WAS IN THE PROTECTIVE SHEATH. THE DEVICE WAS WITHDRAWN INTO THE PROTECTIVE SHEATH, AND THE MICROCATHETER WAS FLUSHED, BUT AFTER REPEATED ATTEMPTS, THE COIL COULD NOT BE PUSHED OUT. THE COIL WAS THEN WITHDRAWN. THE COIL WAS OBSERVED TO BE STRETCHED. ANOTHER OF THE SAME DEVICE WAS USED. A TOTAL OF 10 OTHER COILS WERE PUSHED IN, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE COIL ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20360536 ↗
• MalfunctionSep 17, 2024Stretched; Stretched

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21-AUG-2024. IT WAS REPORTED THAT COIL WAS STRETCHED. THE PATIENT UNDERWENT A SPLENIC ANEURYSM EMBOLIZATION. A 22MM X 60CM INTERLOCK WAS SELECTED FOR USE. AFTER THE STC 18 MICROCATHETER WAS SUPER-SELECTED IN PLACE, THE COIL WAS OPENED IN A STERILE MANNER AND WAS CONTINUOUSLY FLUSHED WITH PRESSURIZED HEPARIN. UPON PUSHING AND WITHDRAWING, THE COIL HAD BEEN STRETCHED INTO THE INNER PACKAGING. 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 ARM OF THE COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20239980 ↗
• MalfunctionApr 23, 2024Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 01-APR-2024. IT WAS REPORTED THAT FAILURE TO ADVANCE IN THE CATHETER AND PREMATURE DEPLOYMENT INSIDE THE PATIENT OCCURRED. THE PATIENT UNDERWENT ENDOVASCULAR ANEURYSM REPAIR OF THE TARGET LESION LOCATED IN THE INTERNAL ILIAC ARTERY. DURING THE PROCEDURE, A 22MM X 60CM INTERLOCK WAS LOADED AND PUSHED INTO A 2.0FR NON-BOSTON SCIENTIFIC MICROCATHETER. ARM-LOCKING WAS RELEASED INSIDE THE MICROCATHETER; HOWEVER, THE COIL COULD NOT BE PUSHED OUT DESPITE SEVERAL ATTEMPTS. THE ENTIRE CATHETER WAS REMOVED FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT CONDITION WAS FINE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164697 ↗
• MalfunctionApr 2, 2024Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12MAR2024. IT WAS REPORTED THAT THE COIL COULD NOT BE COMPLETELY PUSHED OUT OF THE PROTECTIVE SHEATH, HALF IN THE MICROCATHETER AND HALF IN THE PROTECTIVE SHEATH. THE TARGET LESION WAS LOCATED IN THE ILIAC ANEURYSM. THE 22MM X 60CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, AN STC18 MICROCATHETER WAS USED FOR ADVANCING THE COIL, HOWEVER, IT WAS NOTED THAT THE COIL COULD NOT BE COMPLETELY PUSHED OUT OF THE PROTECTIVE SHEATH, HALF IN THE MICROCATHETER AND HALF IN THE PROTECTIVE SHEATH. THE COIL STILL COULD NOT BE PUSHED OUT EVEN AFTER SEVERAL ATTEMPTS. THE COIL WAS WITHDRAWN, AND 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 PUSHER WIRE WAS DETACHED AT THE COIL SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19027808 ↗
• MalfunctionAug 8, 2023Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17JUL2023. IT WAS REPORTED THAT THE COIL COULD NOT BE PUSHED OUT OF THE MICROCATHETER. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A 22MM X 60CM INTERLOCK WAS SELECTED FOR USE FOR EMBOLIZATION WITH 18 OTHER COILS. DURING THE PROCEDURE, THE THIRD 22MMX60CM COIL WAS PUSHED OUT, AFTER IT WAS ADVANCED HALF OF THE NON BOSTON SCIENTIFIC MICROCATHETER. HOWEVER, THE RESISTANCE BECAME LARGER AND IT COULD NOT BE PUSHED OUT. IN ORDER TO ENSURE THE SUCCESSFUL COMPLETION OF THE PROCEDURE, A NEW MICROCATHETER AND A NEW COIL OF THE SAME MODEL WERE USED TO CONTINUE THE PROCEDURE. THE DEVICE WAS SUCCESSFULLY DEPLOYED AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE MAIN COIL WAS DETACHED AT THE ZAP TIP SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17482441 ↗
• InjuryJun 27, 2023Difficult to Remove; Stretched; Failure to Advance; Difficult to Remove; Stretched; Failure to Advance

  IT WAS REPORTED THAT THE COIL WAS STUCK. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A 22MM X 60CM F-IDC 2D INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS NOT POSITIONED SATISFACTORILY WHEN RELEASED. THE DEVICE WAS RETRACTED AND REPOSITION, HOWEVER, HALF OF THE COIL GOT STUCK IN THE MICROCATHETER AND COULD NOT BE RETRACTED, AND THEN THE PHYSICIAN TRIED SEVERAL TIMES BUT STILL COULD NOT BE RETRACTED. THE SALINE WAS FLUSHED AND OTHER METHODS WERE PERFORMED BUT STILL COULD BE RESOLVED. THE COIL WAS STRETCHED INSIDE THE PATIENT'S BODY AND THE PHYSICIAN REFERRED THE PATIENT FOR OPEN PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. IT WAS FURTHER REPORTED THAT THE MICROCATHETER USED WAS STC18 AND A SPLENIC ARTERY RESECTION WAS PERFORMED TO REMOVE THE COIL. THE PATIENT STATUS WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17210162 ↗
• MalfunctionMay 8, 2023Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT THE COIL WAS STUCK IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE GASTRIC VEIN. A 22MM X 60CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS STUCK IN THE CATHETER. AFTER MANY ATTEMPTS, THE COIL STILL COULD NOT BE ADVANCED. THE DEVICE WAS REMOVED TOGETHER WITH THE CATHETER AND 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 INTERLOCKING ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16885988 ↗
• MalfunctionFeb 20, 2023Difficult to Advance; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 31JAN2023. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED FROM THE CATHETER. A 22MM X 60CM INTERLOCK COIL WAS SELECTED FOR USE IN THE AORTA ABDOMINALIS. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT PUSH OUT FROM THE CATHETER CAVITY EVEN AFTER SEVERAL ATTEMPTS DUE TO OBVIOUS RESISTANCE DURING THE CONVEYING PROCESS. THE COIL WAS SIMPLY PULLED OUT FROM THE PATIENT'S BODY 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 THAT THE MAIN COIL WAS DETACHED AT INTERLOCKING ARM SECTION AND THE INTERLOCKING ARM OF THE PUSHER WIRE WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16404785 ↗
• MalfunctionSep 7, 2022Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED FROM THE CATHETER. A 22MM X 60CM INTERLOCK COIL WAS SELECTED FOR USE IN THE ABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE ADVANCED FROM THE CATHETER. THE COIL WAS SIMPLY PULLED OUT FROM THE PATIENT'S BODY 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 A DETACHED INTERLOCKING ARM AND MISSING COIL FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15375356 ↗
• MalfunctionJul 22, 2022Difficult to Insert; Difficult to Insert

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30JUN2022. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED IN THE MICROCATHETER. A 22MMX60CM INTERLOCK COIL WAS SELECTED FOR USE ON THE ARTERIOVENOUS MALFORMATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE ADVANCED IN THE DIREXION MICROCATHETER. 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 MISSING FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15086358 ↗
• MalfunctionJun 2, 2022Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12MAY2022. IT WAS REPORTED THAT THE COIL DID NOT COME OUT. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 22MM X 60CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THERE WAS SOMETHING JAMMED INSIDE THE CATHETER AND THE COIL DID NOT COME OUT WHEN PUSHED. THE ENTIRE MICROCATHETER WAS REMOVED FROM THE PATIENT'S BODY. WHEN CHECKED OUTSIDE PATIENT, THE COIL AND WIRE WERE DETACHED INSIDE THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WERE MISSING FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14582801 ↗
• 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 22MM X 60CM 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 14575444 ↗
• MalfunctionApr 27, 2022Entrapment of Device; Entrapment of Device

  IT WAS NOTED THAT THE COIL PROTRUDED A FEW CENTIMETERS FROM THE TIP OF THE CATHETER UPON REMOVAL. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS INTERNAL ILIAC ARTERY. A 22MM X 60CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL COULD BE NO LONGER ADVANCE IN THE MIDDLE PART INTO THE CATHETER AND WAS THEN REMOVED TOGETHER FROM THE PATIENT'S BODY. UPON REMOVAL, IT WAS FOUND THAT THE COIL PROTRUDED A FEW CENTIMETERS FROM THE TIP OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14228090 ↗
• MalfunctionMar 28, 2022Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02MAR2022. IT WAS REPORTED THAT THE COIL WAS UNABLE TO ADVANCE WITHIN THE SHEATH. A 22MMX60CM INTERLOCK COIL WAS SELECTED FOR USE ON AN OVARIAN VEIN EMBOLIZATION. DURING THE COURSE OF THE PROCEDURE, THE INTRODUCER SHEATH OF THE DEVICE WAS PLACED SNUG TO THE MICROCATHETER HUB (BUT NOT TOO TIGHTLY). THE INTRODUCER SHEATH WAS UNTWISTED, AND A SMALL AMOUNT OF ADVANCEMENT OF THE DELIVERY WIRE WAS DONE BEFORE RESISTANCE WAS FELT. IT WAS NOTED THAT THE COIL WAS UNABLE TO PUSH ANY FURTHER WITHIN INTRODUCER SHEATH AND IT HAD NOT EXITED INTRODUCER SHEATH. THE PROCEDURE WAS COMPLETED VIA ALTERNATIVE METHOD. 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 13933267 ↗
• MalfunctionMar 24, 2022Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED INTO THE MICROCATHETER. A 22MM X 60CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE ADVANCED INTO THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND PATIENT WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WAS A MISSING FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13877902 ↗
• MalfunctionFeb 25, 2022Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 03FEB2022. IT WAS REPORTED THAT THE COIL BECAME STUCK IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS INTERNAL ILIAC ARTERY. A 22MMX60CM 2D INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL BECAME STUCK IN THE CATHETER MIDDLE PART. THE COIL WAS PULLED OUT AS IT IS FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY. HOWEVER, DEVICE ANALYSIS REVEALED MISSING FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13598232 ↗
• MalfunctionFeb 24, 2022Difficult to Remove; Difficult to Remove

  REPORTABLE BASED ON DEVICE INVESTIGATION COMPLETED ON 01FEB2022. IT WAS REPORTED THAT THE DEVICE WAS STUCK. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 22MM X 60CM PE F-IDC INTERLOCK EMBOLICS WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS STUCK INSIDE THE HUB PART OF THE CATHETER AND WAS REMOVED TOGETHER WITH THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS FINE. HOWEVER, DEVICE INVESTIGATIONS REVEALED THAT FIBER BUNDLES WERE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13592366 ↗
• MalfunctionJan 20, 2022Difficult to Insert; Material Deformation; Material Integrity Problem; Difficult to Insert; Material Deformation; Material Integrity Problem

  REPORTABLE BASED ON DEVICE INVESTIGATIONS COMPLETED ON 28DEC2021. IT WAS REPORTED THAT THE DEVICE WAS KINKED. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A 22MM X 60CM PE-F IDC INTERLOCK EMBOLICS WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT AFTER HYDRATING THE INTERLOCK WITH HEPARIN, IT WAS TRIED DELIVERED THROUGH THE MICROCATHETER, HOWEVER, THE DEVICE WAS DIFFICULT TO DELIVER. AFTER MULTIPLE ATTEMPTS, THE PUSH ROD OF THE DEVICE AND THE OUTER PLASTIC CATHETER WERE KINKED AND DEFORMED. THE DEVICE WAS SIMPLY PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WERE MISSING FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13310873 ↗
• MalfunctionJan 5, 2022Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 13DEC2021. IT WAS REPORTED THAT THE COIL BECAME STUCK INSIDE THE CATHETER MIDDLE PART. A 22MMX60CM 2D INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL BECAME STUCK INSIDE THE CATHETER MIDDLE PART. THE COIL WAS PULLED OUT FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM OF THE MAIN COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13172797 ↗