Interlock™ M001361510Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 08714729764946), received between Jan 16, 2019 and Jul 20, 2026 — classified as 3 injuries, 23 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• InjuryJul 20, 2026Break; Stretched; Separation Failure

  IT WAS REPORTED THAT A COIL BREAK OCCURRED, REQUIRING ADDITIONAL INTERVENTION. THE NON-STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED SPLENIC ARTERY. A 3 MM X 12 CM INTERLOCK COIL WAS SELECTED FOR A SPLENIC ARTERY EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, AFTER REACHING THE TARGET LESION, COIL DETACHMENT WAS ATTEMPTED. HOWEVER, THE COIL DID NOT DETACH PROPERLY. UNRAVELING OCCURRED WHILE MOVING NOT ONLY THE DELIVERY WIRE BUT ALSO THE ENTIRE CATHETER BACK AND FORTH. ATTEMPTS WERE MADE TO RETRIEVE THE COIL USING A NON-BOSTON SCIENTIFIC 2TIP STRAIGHT MICROCATHETER AND A SNARE, BUT RETRIEVAL WAS UNSUCCESSFUL. UPON RETRIEVAL, FLUOROSCOPIC IMAGING OF THE ABDOMINAL AORTA CONFIRMED SEPARATION OF THE INTERLOCKING ARM ON THE DELIVERY WIRE SIDE, WHICH REMAINED WITHIN THE ABDOMINAL AORTA. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 25876917 ↗
• MalfunctionJan 7, 2026Difficult to Remove; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 12DEC2025. THE TARGET LESION WAS LOCATED IN THE PSEUDOANEURYSM OF THE RIGHT THIGH. A 3MM X 12CM PE F-IDC COIL WAS SELECTED FOR USE IN A PERCUTANEOUS ARTERIAL EMBOLIZATION. DURING THE PROCEDURE, THE COIL WAS STUCK AT THE TIP OF THE MICROCATHETER. MULTIPLE ATTEMPTS TO PUSH IT WERE UNSUCCESSFUL, AND THE COIL COULD NOT BE WITHDRAWN. CONSEQUENTLY, THE COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT 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 23996617 ↗
• MalfunctionDec 19, 2025Premature Activation; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Premature Activation; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 5DEC2025. IT WAS REPORTED THAT UNABLE TO ADVANCE IN CATHETER OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE CORONARY ARTERIOVENOUS FISTULA. A 3MM X 12CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, COIL COULD NOT BE ADVANCED THROUGH THE STC18 MICROCATHETER DESPITE MULTIPLE ATTEMPTS AND FLUSHING. THE PHYSICIAN ATTEMPTED TO WITHDRAW THE COIL, IT BECAME DETACHED WITHIN THE DELIVERY SYSTEM AND COULD NOT BE RETRACTED INTO THE PROTECTIVE SHEATH AT THE Y-VALVE. THE COIL WAS REPLACED WITH ANOTHER DEVICE OF THE SAME TYPE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PUSHER WIRE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23849733 ↗
• MalfunctionNov 18, 2025Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21OCT2025. IT WAS REPORTED THAT THE COIL WAS UNABLE TO ADVANCE. THE PATIENT WAS PRESENTED WITH A GASTRODUODENAL ANEURYSM. A 3MM X 12CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE COIL PUSHED TO THE POSITION OF THREE QUARTERS OF THE RENEGADE STC-18 MICROCATHETER, THE COIL COULD NOT CONTINUE TO ADVANCE. THE COIL WAS WITHDRAWN AND PUSHED IN AGAIN, HOWEVER, IT WAS FOUND THAT THE ARM COULD NOT BE PUSHED OUT OF THE SHEATH. THE COIL WAS WITHDRAWN, 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 DETACHED ARM COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23584551 ↗
• MalfunctionOct 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 25SEP2025. IT WAS REPORTED THAT THE COIL BECAME STUCK IN THE CATHETER. A 3MM X 12CM INTERLOCK COIL WAS SELECTED FOR ARTERIOVENOUS MALFORMATION PROCEDURE (AVM). HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL BECAME STUCK IN THE CATHETER. 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 PUSHER WIRE WAS BROKEN IN HALF AND COIL ARM WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23356625 ↗
• MalfunctionSep 4, 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 08AUG2025. IT WAS REPORTED THAT THE COIL COULD NOT ADVANCE INTO THE LESION. THE GREATER THAN 70% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND MODERATELY CALCIFIED ILIAC ARTERY. A 3MM X 12CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT ADVANCE INTO THE LESION. 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 MAIN COIL WAS DETACHED AT THE COIL ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22965523 ↗
• MalfunctionJul 10, 2025Difficult to Remove; Stretched; Failure to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Stretched; Failure to Advance; Material Deformation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2025. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED AND WITHDRAWN. A 3MM X 12CM INTERLOCK? 2D COIL WAS SELECTED FOR EMBOLIZATION OF INTERNAL ILIAC ARTERY BRANCH. DURING THE PROCEDURE, THE COIL WAS ADVANCED THROUGH A 2.1F DIREXION MICROCATHETER. HOWEVER, IT WAS NOTED THAT IT COULD NOT CONTINUE TO PUSH AND COULD NOT BE WITHDRAWN. AS A RESULT, THE COIL WAS WITHDRAWN TOGETHER WITH THE CATHETER. UPON INSPECTION, IT WAS NOTED THAT THE COIL WIRE WAS STRETCHED AND KINKED. 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 22469421 ↗
• InjuryOct 7, 2024Migration; Migration

  IT WAS REPORTED THAT COIL MIGRATION OCCURRED REQUIRING ADDITIONAL INTERVENTION. THE TARGET LESION WAS LOCATED IN THE GASTRO DUODENAL ARTERY. A 3MM X 12CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, UPON EMBOLIZATION, THE INTERLOCK COIL MIGRATED INTO THE COMMON HEPATIC ARTERY. THE COIL WAS ATTEMPTED TO BE SNARED OUT, BUT IT WAS NOT RETRIEVED. THE PATIENT WAS SCHEDULED FOR AN OPEN RETRIEVAL OF THE COIL.

  Patient problems: Foreign Body In Patient

  MAUDE report 20387912 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED REBLEEDING AND LOW HEMOGLOBIN LEVELS. THE PATIENT PRESENTED WITH A HISTORY OF PANCREATITIS, WHICH LED TO ACTIVE BLEEDING. THE PREFERRED TREATMENT FOR THIS CONDITION IS TO OCCLUDE THE PSEUDOANEURYSM USING AN INTERVENTIONAL PROCEDURE. ON (B)(6) 2024, A NON-BOSTON SCIENTIFIC (BSC) COIL WAS PLACED PERCUTANEOUSLY INSIDE THE PSEUDOANEURYSM. ON (B)(6) 2024, A COMPUTED TOMOGRAPHY (CT) SCAN DOCUMENTED THAT THE PSEUDOANEURYSM REMAINS PERMEABLE. THIS IS LIKELY DUE TO THE USE OF A SINGLE COIL, WHICH DID NOT ACHIEVE TOTAL THROMBOSIS OF THE PSEUDOANEURYSM. ON (B)(6) 2024, A 3MM X 12CM INTERLOCK, 3MM X 10CM IDC, AND 2MM X 4CM IDC WERE PLACED ENDOVASCULARLY AT THE ORIGIN OF THE LEFT GASTRIC ARTERY, WHICH PROVIDED IRRIGATION TO THE LEFT GASTRIC ARTERY. ON (B)(6) 2024, A CT SCAN WAS PERFORMED DUE TO REBLEEDING AND LOW HEMOGLOBIN LEVELS, FINDING A PERMEABLE PSEUDOANEURYSM AFTER OCCLUSION OF THE NOURISHING ARTERY WITH THE BSC THREE COILS. ON (B)(6) 2024, BASED ON THE TOMOGRAPHY FINDINGS, THE PHYSICIAN DECIDED TO PLACE ADDITIONAL NON-BOSTON SCIENTIFIC COILS. A REPEAT CONTROL AT 15 MINUTES SHOWED NO VISUALIZED FLOW DISTAL TO THE COILS INSIDE THE LEFT GASTRIC

  Patient problems: Anemia; Hemorrhage/Blood Loss/Bleeding; Pseudoaneurysm

  MAUDE report 20345881 ↗
• MalfunctionNov 7, 2023Material Deformation; Material Deformation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18OCT2023. IT WAS REPORTED THAT THE COIL WAS KINKED IN THE MICROCATHETER. A 3MM X 12CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS KINKED IN THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. 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 18088095 ↗
• MalfunctionAug 22, 2022Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT THE COIL PROTRUDED FORM THE CATHETER'S TIP UPON REMOVAL. THE TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND NON CALCIFIED INTERNAL ILIAC ARTERY. A 3MM X 12CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK IN THE DISTAL PART OF THE CATHETER. FURTHERMORE, COIL PROTRUDED FROM THE TIP OF THE CATHETER UPON REMOVAL TOGETHER WITH THE CATHETER. THE USE OF THIS DEVICE WAS CANCELLED BUT THE INTENDED PROCEDURE WAS COMPLETED. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15264599 ↗
• MalfunctionJun 10, 2022Premature Activation; Premature Activation

  REPORTABLE BASED ON DEVICE INVESTIGATIONS COMPLETED ON 20MAY2022. IT WAS REPORTED THAT THE COIL WAS DEPLOYED IN THE MICROCATHETER. A 3MM X 12CM INTERLOCK EMBOLICS WAS SELECTED FOR USE. DURING DEPLOYMENT, THE COIL WAS DEPLOYED IN THE MICROCATHETER, HOWEVER, IT WAS IMPOSSIBLE TO RECOVER IT. THERE WERE NO COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14654953 ↗
• MalfunctionOct 19, 2021Component Missing; Material Integrity Problem; Component Missing; Material Integrity Problem

  IT WAS REPORTED THAT THE COIL WAS DAMAGED. A 3MMX12CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS NOT ATTACHED. IT IS UNKNOWN WHETHER THE COIL GOT EARLY DETACHED OR THE COIL WAS NOT ATTACHED FROM THE BEGINNING. PER PHYSICIAN'S COMMENT, THE DEVICE IS THE CAUSE OF THIS EVENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12656112 ↗
• MalfunctionOct 1, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED AT CATHETER'S TIP. THE TARGET LESION WAS LOCATED IN THE LUMBAR ARTERY. A 3MMX12CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK WHEN THE TIP OF THE COIL WAS INSERTED FEW CENTIMETERS INTO THE BLOOD VESSEL AND WAS PROTRUDING FROM THE CATHETER'S TIP. A PULLBACK WAS ABLE TO PERFORM AND ONLY THE COIL WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12561727 ↗
• MalfunctionOct 1, 2021Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER TIP WHEN REMOVED. THE TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED INFERIOR MESENTERIC ARTERY. A 3MM X 12CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK IN THE CATHETER. FLUSHING WAS PERFORMED INTERMITTENTLY PRIOR TO REMOVAL OF COIL. HOWEVER, IT WAS FURTHER NOTED THAT THE COIL PROTRUDED FROM THE CATHETER TIP DURING 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 12560468 ↗
• MalfunctionJan 28, 2021Contamination; Contamination

  IT WAS REPORTED THAT THE DEVICE WAS CONTAMINATED. A 3MM X 12CM INTERLOCK EMBOLIC COIL WAS SELECTED FOR USE IN A TRANS-ARTERIAL CHEMOEMBOLIZATION (TACE). DURING PREPARATION, THE COIL WAS BEING FLUSHED BY THE TECHNICIAN. HOWEVER, IT GOT CONTAMINATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11244412 ↗
• MalfunctionOct 13, 2020Entrapment of Device; Difficult to Remove; Stretched; Entrapment of Device; Difficult to Remove; Stretched

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29SEP2020. IT WAS REPORTED THAT RESISTANCE WAS FELT UPON WITHDRAWAL OF HALF OF THE COIL AND IT WAS STRETCHED. THE TARGET LESION WAS LOCATED IN THE PULMONARY ARTERY. A 3MMX12CM INTERLOCK COIL WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT DEVICE POSITION WAS NOT GOOD. THE PHYSICIAN WITHDREW THE COIL, HOWEVER THERE WAS RESISTANCE WHEN WITHDRAWING HALF OF THE COIL AND THE COIL DELIVERY DEVICE WAS STRETCHED. THE SHEATH WAS ALSO TIGHT AGAINST THE MICRO CATHETER. THE DEVICE WAS SUCCESSFULLY REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM OF THE PUSHER WIRE WAS DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10672916 ↗
• MalfunctionJul 28, 2020Material Integrity Problem; Material Protrusion/Extrusion; Material Integrity Problem; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE COIL STICKS OUT OF THE TARGET LESION. THE TARGET LESION AREA WAS LOCATED IN A MODERATELY TORTUOUS GASTRODUODENAL ARTERY. A 3MM X 12CM INTERLOCK PE-F IDC WAS SELECTED FOR USE. DURING PROCEDURE, THE COIL WAS NOT COILED UP AROUND THE BLOOD VESSEL, SO THE TIP OF THE COIL PROTRUDED OUT OF THE LESION. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL DEVICE. NO COMPLICATIONS REPORTED. PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10332711 ↗
• MalfunctionJun 12, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER'S TIP DURING REMOVAL. A 3MMX12CM INTERLOCK COIL WAS SELECTED FOR USE IN A SEVERELY TORTUOUS VESSEL. DURING PROCEDURE, 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. ONLY THE COIL WAS REMOVED AS IT WAS 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 10148349 ↗
• MalfunctionMay 4, 2020Separation Failure; Separation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30APR2020. IT WAS REPORTED THAT THE INTERLOCKING ARMS COULD NOT DEPLOY. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A 3MM X 12CM INTERLOCK COIL WAS SELECTED FOR USE IN THE EMBOLIZATION OF RUPTURED SPLENIC ANEURYSM FOR SEVERE ABDOMINAL PAIN. DURING PROCEDURE, A BSC MICROCATHETER WAS ADVANCED INTO THE SPLENIC ANEURYSM FOR BLOOD SUPPLY ANGIOGRAPHY. THE COIL WAS USED FOR EMBOLIZATION, HOWEVER THE INTERLOCKING DETACHABLE ARMS COULD NOT DEPLOY AFTER ENTERING INTO THE VESSEL. THEN, IT WAS WITHDRAWN AND WAS TRIED IN THE MICROCATHETER. SUBSEQUENTLY, UPON ADVANCEMENT OF THE COIL FOR REPOSITIONING, THE INTERLOCKING ARMS STILL COULD NOT DEPLOY AFTER BEING FLUSHED WITH SALINE. HOWEVER, IT WAS FURTHER REPORTED THAT CONTINUOUS FLUSHING WAS PERFORMED. THE DEVICE WAS REMOVED AND COMPLETED THE PROCEDURE WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED MISSING FIBER BUNDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10021517 ↗
• MalfunctionApr 27, 2020Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT COIL PROTRUSION OCCURRED. THE TARGET LESION AREA WAS LOCATED IN A MODERATELY TORTUOUS VESSEL IN THE ABDOMEN. A 2D 3MMX12CM INTERLOCK PE F-IDC EMBOLIC, A 2D 6MMX20CM INTERLOCK PE F-IDC EMBOLIC, AND 2 2D 4MMX15CM INTERLOCK PE F-IDC EMBOLICS WERE ATTEMPTED TO BE USED DURING AN ENDOLEAK PREVENTION PROCEDURE WITHIN THE ABDOMEN. DURING THE PROCEDURE, THE COILS BECAME STUCK INSIDE THE MICROCATHETER AND COULD NOT BE DETACHED. SUBSEQUENTLY, THE COILS WERE REMOVED TOGETHER WITH THE MICROCATHETER AND WERE NOTED TO BE PROTRUDING FROM THE TIP OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH NEW COILS OF THE SAME SIZES. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10001371 ↗
• MalfunctionMar 16, 2020Entrapment of Device; Stretched; Entrapment of Device; Stretched

  IT WAS REPORTED THAT A COIL PROTRUSION OCCURRED. THE TARGET LESION WAS LOCATED IN THE INFERIOR MESENTERIC ARTERY. A 3MM X 12CM INTERLOCK WAS SELECTED FOR USE IN AN ARTERIOVENOUS FISTULA COIL EMBOLIZATION. DURING COILING, IT WAS NOTED THAT THE DEVICE GOT UNRAVELED. THE COIL ARM PART WAS BEING CONNECTED WITH THE INTRODUCER SHEATH FIT IN THE HUB DURING INSERTION. SUBSEQUENTLY, THE COIL WAS REMOVED WITH THE MICROCATHETER AND CONTINUOUS FLUSHING WAS PERFORMED. HOWEVER, UPON REMOVAL, IT WAS NOTED THAT THE COIL PROTRUDED FROM THE CATHETER'S TIP. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9835479 ↗
• MalfunctionFeb 24, 2020Stretched; Separation Failure; Detachment of Device or Device Component; Stretched; Separation Failure; Detachment of Device or Device Component

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18FEB2020. IT WAS REPORTED THAT THE COIL COULD NOT BE DETACHED AND WAS FOUND STRETCHED. THE TARGET LESION WAS LOCATED IN THE LEFT RENAL ARTERY. A 3MM X 12CM INTERLOCK COIL WAS SELECTED FOR USE IN A PERCUTANEOUS ARTERIOGRAPHY AND EMBOLIZATION. THE PATIENT WAS ADMITTED DUE TO BLEEDING IN RENAL ARTERY TRAUMA. DURING THE PREPARATION, THE PHYSICIAN PUSHED THE WIRE REPEATEDLY OUT OF THE MICRO CATHETER, HOWEVER, THE COIL COULD NOT DETACH. SUBSEQUENTLY, THE PHYSICIAN REMOVED THE 3*12 COIL OUTSIDE THE BODY AND FOUND OUT THAT THE COIL WAS STRETCHED AND CANNOT BE USED. HOWEVER, IT WAS FURTHER REPORTED THAT CONTINOUS FLUSHING WAS BEING USE AND WAS PERFORMED BEFORE INTRODUCTION OF THE COIL IN A HAND INJECTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM WAS DETACHED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9745158 ↗
• MalfunctionFeb 14, 2020Entrapment of Device; Entrapment of Device

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 05FEB2020. IT WAS REPORTED THAT THE COIL WAS STUCK INSIDE THE MICROCATHETER. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED ILIAC ARTERY VEIN ARTERIOVENOUS FISTULA. A 3MM X 12CM INTERLOCK COIL WAS SELECTED FOR USE IN A VASCULAR EMBOLIZATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS STUCK INSIDE THE MICROCATHETER. THE ARM OF THE COIL WAS CONNECTED DURING PREPARATION WITH THE INTRODUCER SHEATH FIT IN THE HUB DURING COIL INSERTION. DURING ADVANCEMENT, THE DELIVERY WIRE WAS NOT ROTATED MORE THAN ONCE WITH THE TWIST LOCK COMPLETELY OPENED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED MISSING FIBER BUNDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9711332 ↗
• MalfunctionAug 9, 2019Difficult to Remove; Material Integrity Problem; Material Protrusion/Extrusion; Difficult to Remove; Material Integrity Problem; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE COIL WAS DIFFICULT TO REMOVE AND PROTRUDED FROM THE CATHETER UPON REMOVAL. THE TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS VESSEL. A 3MM X 12CM INTERLOCK COIL WAS SELECTED USE WITH INTERMITTENT FLUSH PERFORMED. DURING PROCEDURE, IT WAS REPORTED THAT THE COIL DID NOT COIL UP IN THE BLOOD VESSEL. THE PHYSICIAN ATTEMPTED TO RETRIEVE, HOWEVER THERE WAS RESISTANCE AND IT WAS DIFFICULT TO RETRIEVE. THE COIL WAS REMOVED FROM THE PATIENT'S BODY. THE COIL WAS REMOVED TOGETHER WITH THE CATHETER. HOWEVER, THE COIL PROTRUDED FROM THE DISTAL TIP OF CATHETER DURING REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8879114 ↗