Interlock™-35 M001363620Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 08714729793175), received between Sep 24, 2018 and Apr 7, 2026 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Entrapment of Device” (7 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.

• MalfunctionApr 7, 2026Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A 12MM X 20CM INTERLOCK .035 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS INSERTED INTO THE CATHETER. HOWEVER, IT COULD NOT PASS THE ANGULATION OF THE INTERNAL ILIAC ARTERY (IIA) DUE TO TORTUOSITY. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24807819 ↗
• MalfunctionApr 6, 2026Failure to Advance

  IT WAS REPORTED THAT PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 12MM X 20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL COULD NOT PASS THE ANGULATION OF THE LESION DUE TO TORTUOSITY. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792347 ↗
• MalfunctionJan 20, 2026Separation Failure; Difficult to Advance

  IT WAS REPORTED THAT PROCEDURE WAS CANCELLED. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 12MM X 20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL DID NOT ADVANCE IN THE CATHETER AND WHEN ATTEMPTED TO RELEASE THE INTERLOCK, THE RELEASE MECHANISM FAILED TO FUNCTION AS INTENDED. MULTIPLE ATTEMPTS WERE MADE TO RELEASE THE DEVICE, BUT ALL WERE UNSUCCESSFUL. THE COIL WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24121083 ↗
• MalfunctionJan 20, 2026Separation Failure; Difficult to Advance

  IT WAS REPORTED THAT PROCEDURE WAS CANCELLED. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED VESSEL. A 12MM X 20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL DID NOT ADVANCE IN THE CATHETER AND WHEN ATTEMPTED TO RELEASE THE INTERLOCK, THE RELEASE MECHANISM FAILED TO FUNCTION AS INTENDED. MULTIPLE ATTEMPTS WERE MADE TO RELEASE THE DEVICE, BUT ALL WERE UNSUCCESSFUL. THE COIL WAS REMOVED FROM THE PATIENT, AND THE PROCEDURE WAS CANCELLED. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24116898 ↗
• MalfunctionJul 22, 2025Stretched; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Stretched; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25JUN2025. IT WAS REPORTED THAT COIL WAS UNABLE TO ADVANCE AND WAS STRETCHED. A 12MM X 20CM INTERLOCK-35 WAS SELECTED FOR PORTAL VEIN EMBOLIZATION (PVE) PROCEDURE. DURING THE PROCEDURE, THE COIL WAS DIFFICULT TO DELIVER AND BECAME STRETCHED WHEN HALF OF THE COIL WAS RELEASED. THE COIL WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED DETACHED AT THE COIL ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22568348 ↗
• MalfunctionMar 14, 2025Stretched; Failure to Advance; Separation Failure; Stretched; Failure to Advance; Separation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 14FEB2025. IT WAS REPORTED THAT THE COIL WAS DEPLOYED OUTSIDE THE CATHETER AND APPROXIMATELY HALF OF THE COIL WAS STRETCHED AND UNRAVELED. A 12MM X 20CM INTERLOCK-35 COIL WAS SELECTED FOR EMBOLIZATION OF AN ANEURYSM IN THE RIGHT INTERNAL ILIAC ARTERY. THE ANATOMY WAS NON-TORTUOUS. DURING THE PROCEDURE, THE COIL WAS ADVANCED, AND SOME OF THE COIL WAS DEPLOYED OUTSIDE THE NON-BOSTON SCIENTIFIC CATHETER AND IN THE SPACE NEEDED. APPROXIMATELY HALF OF THE COIL WAS STRETCHED AND UNRAVELED ALL THE WAY TO THE PROXIMAL END OF THE CATHETER. ATTEMPTS TO RETRACT THE COIL WERE UNSUCCESSFUL. ATTEMPTS TO PUSH THE COIL OUT WITH A WIRE OR SALINE FLUSH WERE ALSO UNSUCCESSFUL. THE CATHETER WAS CUT AND SEPARATED, AND THE COIL WAS SAFELY REMOVED FROM THE BODY, AND THE DEPLOYMENT CATHETER WAS REMOVED. A NEW CATHETER WAS PLACED INTO THE INTERNAL ILIAC, AND THE PROCEDURE WAS COMPLETED WITH TWO MORE COILS. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE FOR THE ENTIRE PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THE COIL ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21607420 ↗
• MalfunctionDec 14, 2023Premature Activation; Failure to Advance; Material Deformation; Material Integrity Problem; Premature Activation; Failure to Advance; Material Deformation; Material Integrity Problem

  IT WAS REPORTED THAT THE SHEATH WAS FRACTURED. A 12MM X 20CM INTERLOCK-35 COIL WAS SELECTED FOR EMBOLIZATION OF FUNDIC VARICES. DURING THE COURSE OF THE PROCEDURE, THE PHYSICIAN WAS PASSING THE COIL THROUGH THE EXPECT 19G NEEDLE. WHEN THE PROTECTIVE SHEATH OF THE COIL WAS ATTACHED TO THE NEEDLE AND STARTED TO ADVANCE THE COIL, THERE WAS A LOT OF RESISTANCE FELT. THE PROTECTIVE SHEATH WAS FORCEFULLY PULLED OUT OF THE THREE-WAY STOPCOCK, LEAVING THE COIL FREE IN THE VALVE. UPON CHECKING, THE TIP OF THE PROTECTIVE SHEATH WAS COMPLETELY WRINKLED AND FRACTURED AT THE PROXIMAL END DUE TO CONTACT WITH THE EDGE OF THE NEEDLE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. IT WAS FURTHER REPORTED THAT THE DEVICE WAS NOT FRACTURED BUT FLATTENED OR KINKED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18331047 ↗
• MalfunctionDec 14, 2023Entrapment of Device; Stretched; Failure to Advance; Material Integrity Problem; Entrapment of Device; Stretched; Failure to Advance; Material Integrity Problem

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM CATHETER TIP. THE PATIENT WAS BEING TREATED FOR THE MILDLY TORTUOUS VARICOSE VEINS IN THE STOMACH AREA. A 12MM X 20CM INTERLOCK-35 WAS INSERTED THROUGH AN EXPECT 19 C NEEDLE WHEN THE COIL ADVANCED TO THE DISTAL PART OF THE NEEDLE AND GOT STUCK GENERATING A LOT OF RESISTANCE. THE ENTIRE CATHETER WAS REMOVED, BUT WHEN THE COIL WAS PUSHED OUT IT CAME OUT DEFORMED AND ELONGATED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18326051 ↗
• MalfunctionSep 22, 2023Premature Activation; Difficult to Remove; Failure to Advance; Premature Activation; Difficult to Remove; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04SEP2023. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCE HALFWAY. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL CAVITY. A 12MM X 20CM INTERLOCK-35 WAS SELECTED FOR USE. THE DEVICE WAS CONTINUOUSLY FLUSH BEFORE INTRODUCTION OF THE COIL. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE ADVANCE AND WITHDRAWN HALFWAY EVEN AFTER SEVERAL ATTEMPTS. THE WHOLE CATHETER AND THE COIL WERE PULLED OUT TOGETHER FROM THE PATIENT'S BODY. IT WAS THEN FOUND THAT THE COIL HAD BEEN DETACHED INSIDE THE CATHETER. 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 MAIN COIL DETACHED AT THE COIL ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17801888 ↗
• MalfunctionJun 8, 2022Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE INVESTIGATIONS COMPLETED ON 18MAY2022. IT WAS REPORTED THAT ADVANCING FAILURE OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED INTERNAL ILIAC ARTERY. A 12MM X 20CM INTERLOCK-35 EMBOLICS WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE ADVANCED FROM THE INTRODUCER AND WAS HARD, THE COIL DID NOT COME OUT DUE TO THE STACK. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS CONFIRMED THAT THE COIL WAS BROKEN NEAR THE INTERLOCKING ARM AND FIBER LOSS WAS NOTED. IT WAS ALSO FURTHER CONFIRMED THAT NO FIBER RESIDUE LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14633331 ↗
• MalfunctionJun 2, 2022Difficult to Insert; Premature Activation; Difficult to Insert; Premature Activation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10MAY2022. IT WAS REPORTED THAT THE COIL BECAME STUCK IN THE HUB OF THE CATHETER AND DETACHED PREMATURELY NEAR THE TWO-WAY STOPCOCK. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 12MMX20CM INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS STUCK IN THE HUB OF THE CATHETER AND DETACHED PREMATURELY NEAR THE TWO-WAY STOPCOCK. WHEN THE COIL WAS RECOVERED, IT WAS NOTED THAT IT WAS IN A DISCONNECTED STATE INSIDE THE CATHETER. ONLY THE COIL WAS PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 14574784 ↗
• MalfunctionOct 28, 2021Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT THE DEVICE WAS STUCK IN THE CATHETER. A 12MM X 20CM INTERLOCK -35 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN TRYING TO PASS THE DEVICE THROUGH THE CATHETER, IT WAS NOTED THAT THE COIL GOT STUCK INSIDE THE CATHETER. THE DEVICE WAS REMOVED AND 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 12716157 ↗
• MalfunctionAug 31, 2021Premature Activation; Physical Resistance/Sticking; Premature Activation; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2021. IT WAS REPORTED THAT THE INTERLOCKING DETACHED INSIDE THE CATHETER. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A TOTAL OF 3 CONTROLLABLE COILS INCLUDING A 18MMX20CM AND 12MM X 20CM INTERLOCK WERE USED IN THE PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE SECOND COIL (18MMX20CM) WAS STRETCHED AND THE INTERLOCKING ARM DETACHED UPON DELIVERY, PRIOR TO THE COIL BEING SUCCESSFULLY PLACED IN THE PATIENT. SUBSEQUENTLY, PART OF THE COIL WAS STILL IN THE RADIOGRAPHY CATHETER, SO THE PHYSICIAN TRIED TO PUSH THE COIL MANY TIMES OUT OF THE CATHETER BY MEANS OF THE COIL DELIVERY SHAFT, A 0.035 GUIDE WIRE, AND MANUALLY PUSHING HEPARIN SALINE. THESE ATTEMPTS FAILED. THEN, A THIRD COIL (12MMX20CM) SUCCESSFULLY PUSHED THE 18MMX20CM COIL OUT OF THE ANGIOGRAPHY CATHETER AND ATTACHED TO THE LESION. HOWEVER, THE HEAD END OF THE 12MMX20CM COIL COULD NOT BE PUSHED OUT SMOOTHLY AND WAS PREMATURELY DETACHED IN THE CATHETER WHILE TRYING TO DELIVER. THE INTERLOCKING ARM DETACHED IN THE PROCESS OF TRYING TO DELIVER AND THE COIL WAS WITHDRAWN WITH THE ANGIOGRAPHY CATHETER. THE DEVICE WAS COMPLETELY REMOVED WITHOUT ANY INTERV

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12394964 ↗
• MalfunctionMar 15, 2021Entrapment of Device; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22FEB2021. IT WAS REPORTED THAT THE COIL WAS STUCK IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS SUBCLAVIAN ARTERY. A 12MMX20CM 2D INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK IN THE DISTAL PART OF THE CATHETER. THE DEVICE WAS REMOVED TOGETHER WITH THE CATHETER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED MAIN COIL INTERLOCKING ARM DETACHMENT AND FIBER LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11484845 ↗
• MalfunctionFeb 18, 2021Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04FEB2021. IT WAS REPORTED THAT THE COIL BECAME STUCK. THE TARGET LESION AREA WAS LOCATED IN THE INTERNAL ILLIAC ARTERY. A 2D 12MM X 20CM INTERLOCK-35 EMBOLIC WAS SELECTED FOR USE IN A PELVIC CONGESTION PROCEDURE. DURING THE PROCEDURE, THE COIL WAS UNPACKED AND FLUSHED WELL. THE COIL WAS INTRODUCED INTO THE CATHETER. HOWEVER, IT WAS STUCK AT THE DISTAL PART OF THE CATHETER, AT THE CONNECTION PART. THE COIL WAS PULLED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED A DETACHED INTERLOCKING ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11343149 ↗
• MalfunctionSep 30, 2020Premature Activation; Premature Activation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29 SEP 2020. IT WAS REPORTED THAT THE COIL PREMATURELY DEPLOYED. THE TARGET LESION AREA WAS LOCATED IN A MODERATELY TORTUOUS ARTERIOVENOUS MALFORMATION. A 12MM X 20CM INTERLOCK-35 WAS SELECTED FOR AN EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL DEPLOYED BEFORE REACHING THE LESION. THE COIL WAS REMOVED WITH THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT'S CONDITION WAS GOOD POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE COIL INTERLOCKING ARM WAS DETACHED AND FIBER BUNDLES WERE MISSING.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10607740 ↗
• MalfunctionJun 9, 2020Entrapment of Device; Premature Activation; Entrapment of Device; Premature Activation

  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 SUBCLAVIAN ARTERY. A 12MM X 20CM INTERLOCK -35 COIL WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE COIL DETACHED PREMATURELY INSIDE THE MICROCATHETER. 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 MICROCATHETER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10133846 ↗
• MalfunctionJun 3, 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 SEVERELY TORTUOUS AND SEVERELY CALCIFIED ANEURYSM. FOUR INTERLOCK-35 COILS OF DIFFERENT SIZES, NAMELY, 12MMX20CM, 12MMX40CM, 10MMX40CM, AND 15MMX40CM, WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COILS BECAME STUCK IN THE CATHETER. FURTHERMORE, WHEN THE COILS WERE REMOVED FROM THE PATIENT'S BODY, IT WAS NOTED THAT THE COILS PROTRUDED FROM THE TIP OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10115128 ↗
• MalfunctionFeb 18, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED IN THE CATHETER'S TIP DURING REMOVAL. VASCULAR ACCESS WAS VIA THE RIGHT INGUINAL BY IPSILATERAL ANTEGRADE APPROACH. THE TARGET LESION WAS LOCATED IN A MILDLY TORTUOUS AND NON CALCIFIED RIGHT INTERNAL ILIAC. A 12MM X 20CM .035 INTERLOCK COIL WAS SELECTED FOR USE FOR A STENT GRAFT OF AN ABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL BECAME STUCK IN THE AREA WHERE TIP OF THE COIL WAS SLIGHTLY EXTENDED FOR THE DISTAL PART OF THE MICROCATHETER. FURTHERMORE, DURING REMOVAL, THE COIL PROTRUDED FROM THE TIP OF THE CATHETER. THE COIL WAS SIMPLY REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9720506 ↗
• MalfunctionJul 29, 2019Premature Activation; Premature Activation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09JUL2019. IT WAS REPORTED THAT THE PREMATURE DEPLOYMENT OCCURRED. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS INTERNAL ILIAC ARTERY. A 12MM X 20CM INTERLOCK-35 COIL WAS SELECTED FOR USE IN AORTIC ANEURYSM EMBOLIZATION PROCEDURE. DURING PROCEDURE, THE COIL PREMATURELY DETACHED IN THE MICROCATHETER. THE INTERLOCKING ARM OF THE COIL UNLOCKED FROM THE INTERLOCKING ARM OF THE PUSHER WIRE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE COIL INTERLOCKING ARM WAS FOUND DETACHED FROM THE REST OF THE COIL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8837098 ↗
• MalfunctionJun 25, 2019Separation 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 14JUN2019. IT WAS REPORTED THAT THE DEVICE WAS UNABLE TO DEPLOY. A 12MM X 20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING PREPARATION, IT WAS NOTED THAT THE COILD WAS UNABLE TO DEPLOY AND COULD NOT PUSHED THROUGH. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME. THERE WERE NO PATIENT COMPLICATIONS REPORTED. PATIENT IS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT MANY OF THE FIBER BUNDLES WERE DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8732984 ↗
• MalfunctionSep 24, 2018Physical Resistance/Sticking; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05-SEP-2018. IT WAS REPORTED THAT COIL BECAME STUCK IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE MILDLY CALCIFIED INTERNAL ILIAC ARTERY (IIA). A 12MM /20CM INTERLOCK-35 WAS SELECTED FOR USE. DURING PROCEDURE, THE COIL WAS USED IN A 5FR NON-BSC IMAGING CATHETER; HOWEVER, THE COIL GOT STUCK AND COULD NOT BE PUSHED AND PULLED IN THE MID PART OF THE CATHETER. THE COIL WAS THEN REMOVED TOGETHER WITH THE CATHETER FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT COIL INTERLOCKING ARM WAS FOUND DETACHED FROM THE REST OF THE COIL AND NOT RETURNED. THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL INSPECTION WAS PERFORMED ON THE DELIVERY WIRE, COIL AND INTRODUCER SHEATH THAT WERE RETURNED FOR THIS COMPLAINT. THE COIL AND DELIVERY WIRE ARMS WERE INTERLOCKED WITHIN INTRODUCER SHEATH. THE TWIST LOCK OF THE INTRODUCER SHEATH HAD BEEN OPENED. RESIDUES OF BLOOD WERE NOTED WITHIN THE INTRODUCER SHEATH. THE COIL AND DELIVERY WIRE WERE ADVANCED WITH FRICTION FROM THE INTRODUCER SHEATH CAUSED BY THE BLOOD OBSERVED. THE INTRODUCER SHEAT

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7901674 ↗