Interlock™ M001361530Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 08714729764960), received between Nov 26, 2019 and May 8, 2026 — classified as 5 injuries, 29 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (10 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 34 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 8, 2026Difficult to Insert; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT THE DEVICE WAS DIFFICULT TO INSERT. A 4MM X 15CM INTERLOCK COIL WAS SELECTED FOR USE IN THE LEFT ATRIUM. THE ANATOMY WAS MODERATELY TORTUOUS. AN ATTEMPT WAS MADE TO PLACE THE COIL IN THE LEFT ATRIUM, BUT THE NON-BOSTON SCIENTIFIC MICROCATHETER DEVIATED FROM THE ELECTED BLOOD VESSEL. CONSEQUENTLY, THE INTERLOCK COIL WAS REMOVED, AND THE MICROCATHETER WAS REINSERTED INTO THE LEFT ATRIUM. THE SAME COIL WAS ATTEMPTED TO BE INSERTED INTO THE MICROCATHETER, BUT THERE WAS SEVERE RESISTANCE IN THE INSERTER. 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 PUSHER WIRE DETACHMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25129690 ↗
• MalfunctionDec 22, 2025Premature Activation; Difficult to Remove; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Premature Activation; Difficult to Remove; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 10DEC2025. IT WAS REPORTED THAT THE COIL COULD NOT BE PUSHED OUT AND WAS DETACHED BY ITSELF IN THE PROTECTIVE SHEATH. THE TARGET LESION WAS LOCATED IN THE UTERINE ARTERY. A 4MM X 15CM INTERLOCK COIL WAS SELECTED FOR TRANSCATHETER EMBOLIZATION. HOWEVER, DURING ADVANCING, IT WAS NOTED THAT THE COIL COULD NOT BE PUSHED OUT OF THE BOSTON SCIENTIFIC STC 18 MICROCATHETER. AFTER THE COIL WAS WITHDRAWN FROM THE BODY, IT WAS FOUND THAT THE COIL WAS DETACHED BY ITSELF IN THE PROTECTIVE SHEATH, AND THE COIL WAS STUCK IN THE MICROCATHETER. 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 ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23866202 ↗
• MalfunctionOct 20, 2025Contamination; Contamination

  IT WAS REPORTED THAT DEVICE CONTAMINATION OCCURRED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS ENDOVASCULAR ANEURYSM REPAIR (EVAR). A 4MM X 15CM INTERLOCK WAS SELECTED FOR USE. DURING PREPARATION, THE DEVICE WAS ACCIDENTALLY CONTAMINATED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23337072 ↗
• MalfunctionApr 7, 2025Break; Break

  IT WAS REPORTED THAT THE COIL WAS FRACTURED. A 4MM X 15CM 2D INTERLOCK COIL WAS SELECTED FOR CONTRAST MEDIUM ARTERIOGRAPHY PROCEDURE. HOWEVER, THE COIL FRACTURED DURING INSERTION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21791151 ↗
• InjuryDec 11, 2024Break; Stretched; Malposition of Device; Migration; Break; Stretched; Malposition of Device; Migration

  IT WAS REPORTED THAT THE COIL ARM DETACHED AND MIGRATED INTO THE CEREBELLUM. THE NON-STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND NON-CALCIFIED RIGHT INTERNAL THORACIC ARTERY. A 4MM X 15CM INTERLOCK WAS SELECTED FOR COLLATERAL EMBOLISM OF THE INTERNAL THORACIC ARTERY AFTER A GRAEN'S PROCEDURE AND BEFORE A FONTAN PROCEDURE. A TOTAL OF 12 EMBOLIC COILS WERE PLACED IN THE INTERNAL THORACIC ARTERY. HOWEVER, IT WAS OBSERVED THAT THE 9TH COIL WAS PROTRUDING. A SNARE WAS USED TO GRASP THE 9TH COIL. IT WAS GRASPED APPROXIMATELY 1CM FROM THE INTERLOCKING ARM WITH THE SNARE AND PULLED. HOWEVER, THE COIL UNRAVELED AND BROKE OFF AT THE PART WHERE IT WAS SNARED. THE DETACHED COMPONENT MIGRATED INTO THE CEREBRAL BLOOD VESSELS AND DEEP INTO THE CEREBELLUM. A NEUROSURGEON DETERMINED THAT IT COULD NOT BE RETRIEVED. SUBSEQUENT CT AND MRI SCANS HAVE DETERMINED THAT IT IS IMPOSSIBLE TO RETRIEVE THE DETACHED ARM. THE UNRAVELED PART OF THE COIL THAT REMAINED IN THE INTERNAL THORACIC ARTERY WAS RETRIEVED BY A SURGEON THROUGH THORACOTOMY. THE PHRENIC NERVE WAS DAMAGED WHEN THE COIL WAS SURGICALLY RETRIEVED, WHICH CAUSED SOME DIAPHRAGM PROBLEMS. THERE WERE NO FURTHER SIGNS OF AN IMPACT O

  Patient problems: Foreign Body In Patient; Nerve Damage

  MAUDE report 20904232 ↗
• MalfunctionAug 20, 2024Difficult to Insert; Difficult to Insert

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 29JUL2024. IT WAS REPORTED THAT THE COIL WAS DIFFICULT TO INSERT IN THE HUB PART OF THE CATHETER. THE TARGET LESION WAS LOCATED IN THE INFERIOR MESENTERIC ARTERY. A 4MM X 15CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS DIFFICULT TO INSERT IN THE HUB PART. ONLY ABOUT ONE LOOP COULD BE INSERTED, AND IT GOT STUCK. THE COIL WAS REMOVED AS IS AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE MAIN COIL WAS DETACHED AT THE COIL ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20006506 ↗
• MalfunctionMar 4, 2024Stretched; 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 (B)(6) 2024. IT WAS REPORTED THAT COIL ADVANCING AND STRETCHING ISSUES OCCURRED. THE STENOSED TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 4MM X 15CM INTERLOCK COIL WAS SELECTED FOR EMBOLIZATION OF THE INTERNAL ILIAC ANEURYSM. DURING THE PROCEDURE, THE COIL WAS DELIVERED BY A BSC MICROCATHETER FOR EMBOLIZATION, AND HEPARIN SALINE PERFUSION WAS PERFORMED. HOWEVER, CLEAR RESISTANCE WAS FELT, AND THE COIL COULD NOT BE ADVANCED WHEN IT REACHED THE 2-3CM SEGMENT OF THE CATHETER. CONSEQUENTLY, IT WAS FOUND THAT THE COIL WAS STRETCHED UPON REMOVAL FROM 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 DETACHED ZAP TIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18825704 ↗
• MalfunctionDec 15, 2023Failure 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 07DEC2023. IT WAS REPORTED THAT RESISTANCE WAS FELT WHEN ADVANCING THE COIL IN THE CATHETER. A 4MM X 15CM INTERLOCK COIL WAS SELECTED FOR RIGHT LEG ARTERIOVENOUS MALFORMATION PROCEDURE. DURING THE PROCEDURE, THE PHYSICIAN USED A NON-BOSTON SCIENTIFIC MICROCATHETER TO REACH THE LESION. HOWEVER, WHEN THIS COIL WAS ADVANCED, THE COIL COULD NO LONGER BE PUSHED AFTER ABOUT RELEASING ABOUT 2/3 DUE TO OBVIOUS RESISTANCE. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18336391 ↗
• MalfunctionNov 29, 2023Premature Activation; Difficult to Remove; Failure to Advance; Premature Activation; Difficult to Remove; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07NOV2023. IT WAS REPORTED THAT THE COIL COULD NOT ADVANCE AND WITHDRAWN FROM THE CATHETER. THE TARGET LESION WAS LOCATED IN THE PULMONARY ARTERIOVENOUS. A 4MMX15CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE SECOND COIL WAS DEPLOYED, IT WAS NOTED THAT THE COIL COULD NOT ADVANCE IN THE MIDDLE OF THE CATHETER AND WAS DIFFICULT TO REMOVE. AFTER REPEATED ADJUSTMENT, THE COIL GOT DISLODGED IN THE CATHETER. THE COIL WAS REMOVED TOGETHER WITH THE CATHETER 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 COIL DETACHED AT THE ZAP TIP AND COIL ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18232006 ↗
• MalfunctionNov 7, 2023Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT THE END PART OF THE COIL POPPED OUT SLIGHTLY IN THE LESION. THE TARGET LESION WAS LOCATED IN THE CORONARY FISTULA. A 4MMX15CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE TIP END PART OF THE COIL POPPED OUT SLIGHTLY IN THE LESION. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS GOOD POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18085387 ↗
• MalfunctionOct 25, 2023Premature Activation; Difficult to Advance; Material Deformation; Premature Activation; Difficult to Advance; Material Deformation

  REPORTABLE BASED ON THE DEVICE ANALYSIS COMPLETED ON 03OCT2023. IT WAS REPORTED THAT THE COIL WAS DIFFICULT TO ADVANCE AND PREMATURELY DEPLOYED. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS SPLENIC ARTERY. AN 4MM X 15CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT RESISTANCE WAS FELT WHEN ADVANCING THE COIL THROUGH THE DIREXION TRANSEND MICROCATHETER, ALTHOUGH THE COIL WAS PROPERLY FLUSHED BEFORE INSERTION AND CONTINUOUS FLUSH WAS MAINTAINED. ALSO, THE COIL GOT DEPLOYED INSIDE THE MICROCATHETER. THE COIL WAS REMOVED TOGETHER WITH THE MICROCATHETER. THE DEVICE WAS BENT OR KINKED. THE PROCEDURE WAS COMPLETE WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE PUSHER WIRE AND INTRODUCER GOT DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18005415 ↗
• InjuryOct 2, 2023Separation Failure; Malposition of Device; Separation Failure; Malposition of Device

  IT WAS REPORTED THAT A SNARE WAS USED TO REMOVE THE COILS. TWO 4MM X 15CM INTERLOCK COILS WERE SELECTED FOR BRONCHIAL ARTERY EMBOLIZATION (BAE) TOGETHER WITH A BSC STC18 MICROCATHETER. DURING THE PROCEDURE, HEPARIN SALINE WAS PERFUSED BY HAND, AND IT WAS FLUSHED BEFORE INTRODUCING THE COIL. THE FIRST COIL WAS DEPLOYED AS EXPECTED, BUT THE SECOND AND THIRD COILS COULD NOT BE RELEASED THE ENTIRE TIME AND WERE ACCIDENTALLY RELEASED DURING WITHDRAWAL. A SNARE WAS USED TO REMOVE THE COILS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17855125 ↗
• InjuryOct 2, 2023Separation Failure; Malposition of Device; Separation Failure; Malposition of Device

  IT WAS REPORTED THAT A SNARE WAS USED TO REMOVE THE COILS. TWO 4MM X 15CM INTERLOCK COILS WERE SELECTED FOR BRONCHIAL ARTERY EMBOLIZATION (BAE) TOGETHER WITH A BSC STC18 MICROCATHETER. DURING THE PROCEDURE, HEPARIN SALINE WAS PERFUSED BY HAND, AND IT WAS FLUSHED BEFORE INTRODUCING THE COIL. THE FIRST COIL WAS DEPLOYED AS EXPECTED, BUT THE SECOND AND THIRD COILS COULD NOT BE RELEASED THE ENTIRE TIME AND WERE ACCIDENTALLY RELEASED DURING WITHDRAWAL. A SNARE WAS USED TO REMOVE THE COILS, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17854628 ↗
• MalfunctionSep 22, 2023Stretched; Failure to Advance; Stretched; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04SEP2023. IT WAS REPORTED THAT THE COIL STUCK IN THE MIDDLE OF THE CATHETER. THE TARGET LESION WAS LOCATED IN THE SPERMATIC VEIN. A 4MM X 15CM INTERLOCK COIL WAS SELECTED FOR USE. THE DEVICE WAS CONTINUOUSLY FLUSH BEFORE INTRODUCTION OF THE COIL. DURING THE PROCEDURE, A MICROCATHETER WAS USED TO RELEASE TWO COILS, HOWEVER, UPON DEPLOYING THE SECOND COIL IT GOT STUCK IN THE MIDDLE OF THE CATHETER AND COULD NOT BE ADVANCE DESPITE MULTIPLE ATTEMPTS. WHEN THE COIL WAS REMOVED FROM THE CATHETER, IT WAS NOTED THAT THE COIL GOT STRETCHED. 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 17800291 ↗
• MalfunctionAug 28, 2023Entrapment of Device; Failure to Advance; Entrapment of Device; Failure to Advance

  IT WAS REPORTED THAT A COIL PROTRUSION OCCURRED. THE NON-STENOSED TARGET LESION WAS IN A SEVERELY TORTUOUS AND NON-CALCIFIED INFERIOR MESENTERIC ARTERY. A 5MM X 15CM AND A 4MM X 15CM PE F-IDC INTERLOCK WERE SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT COIL GOT STUCK IN THE DISTAL PART OF THE CATHETER AND PROTRUDED FROM THE CATHETER TIP UPON REMOVAL. ONLY THE COIL WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE IS NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17633201 ↗
• MalfunctionDec 12, 2022Entrapment of Device; Entrapment of Device

  IT WAS REPORTED THAT THE COIL PROTRUDED IN THE CATHETER'S TIP DURING REMOVAL. A 4MMX15CM INTERLOCK COIL WAS SELECTED FOR USE IN THE SEVERELY TORTUOUS VESSEL. DURING THE PROCEDURE, THE COIL GOT 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 IN 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 15958748 ↗
• InjuryDec 1, 2022Migration; Migration

  IT WAS REPORTED THAT THE COIL PACK MIGRATED. A 4MM X 15CM INTERLOCK-18 FIBERED INTERLOCKING DETACHABLE COIL WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE TO TREAT A SPLENIC ARTERY ANEURYSM. NEAR THE END OF THE PROCEDURE, THE COIL PACK MIGRATED DOWNSTREAM AT LEAST 5CM DISTALLY IN THE SPLENIC ARTERY. THE COIL PACK CONTAINED NINE COILS. ALL DEVICES WERE LEFT INSIDE THE PATIENT. THE PATIENT WAS ADMITTED FOR OBSERVATION. TISSUE NECROSIS OCCURRED, AND THE PATIENT WAS TREATED FOR ACUTE PANCREATITIS. THE PATIENT WAS ULTIMATELY DISCHARGED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Embolism/Embolus; Necrosis; Pancreatitis

  MAUDE report 15900576 ↗
• InjuryDec 1, 2022Migration; Migration

  IT WAS REPORTED THAT THE COIL PACK MIGRATED. A 4MM X 15CM INTERLOCK-18 FIBERED INTERLOCKING DETACHABLE COIL WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE TO TREAT A SPLENIC ARTERY ANEURYSM. NEAR THE END OF THE PROCEDURE, THE COIL PACK MIGRATED DOWNSTREAM AT LEAST 5CM DISTALLY IN THE SPLENIC ARTERY. THE COIL PACK CONTAINED NINE COILS. ALL DEVICES WERE LEFT INSIDE THE PATIENT. THE PATIENT WAS ADMITTED FOR OBSERVATION. TISSUE NECROSIS OCCURRED, AND THE PATIENT WAS TREATED FOR ACUTE PANCREATITIS. THE PATIENT WAS ULTIMATELY DISCHARGED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: Embolism/Embolus; Necrosis; Pancreatitis

  MAUDE report 15898080 ↗
• MalfunctionSep 14, 2022Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN A SEVERELY TORTUOUS ARTERY. A 4MM X 15CM INTERLOCK 2D WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL GOT STUCK IN THE MIDDLE PART OF THE CATHETER. THE COIL WAS PULLED OUT AND THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15422582 ↗
• MalfunctionAug 17, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2022. IT WAS REPORTED THAT THE COIL WAS STUCK INSIDE THE CATHETER. A 4MM X 15CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS STUCK IN THE MIDDLE OF THE CATHETER. THE COIL WAS REMOVED TOGETHER WITH THE CATHETER. 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 PUSHER WIRE WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15243901 ↗
• MalfunctionAug 10, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15JUL2022. IT WAS REPORTED THAT THE COIL BECAME STUCK IN THE CATHETER. A 4MMX15CM INTERLOCK COIL WAS SELECTED FOR USE ON THE MESENTERIC ARTERY. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL BECAME STUCK IN THE MIDDLE OF THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE PUSHER WIRE WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15202532 ↗
• MalfunctionAug 8, 2022Break; Break

  IT WAS REPORTED THAT THE COIL WAS FRACTURED. THE TARGET LESION WAS LOCATED IN FEMORAL PROFOUND ARTERY BRANCH OF THE THIGH PART. A 4MM X 15CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS FRACTURED UPON USAGE. THE DEVICE WAS SIMPLY PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE . THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15188318 ↗
• MalfunctionApr 20, 2022Entrapment of Device; Premature Activation; Entrapment of Device; Premature Activation

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER'S TIP DURING REMOVAL. A 4MM X 15CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL PREMATURELY DETACHED IN THE CATHETER. CONSEQUENTLY, THE COIL WAS REMOVED TOGETHER WITH THE CATHETER AND IT WAS NOTED THAT THE COIL PROTRUDED FROM THE CATHETER'S TIP. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14164447 ↗
• MalfunctionMar 24, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS INFERIOR MESENTERIC ARTERY. A 4MM X 15CM PE F-IDC INTERLOCK EMBOLICS WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK IN THE MIDDLE OF THE CATHETER. THE DEVICE WAS REMOVED TOGETHER WITH THE CATHETER. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13897205 ↗
• MalfunctionNov 3, 2021Entrapment of Device; Premature Activation; Entrapment of Device; Premature Activation

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER TIP WHEN REMOVED. THE TARGET LESION WAS LOCATED IN THE INTERNAL MESENTERIC ARTERY. A 4MMX15CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, THE MAIN COIL AND THE ARM OF THE DELIVERY WIRE SEPARATED EARLY IN THE DISTAL PART OF THE CATHETER. THE COIL WAS REMOVED TOGETHER WITH THE CATHETER, HOWEVER IT PROTRUDED FROM THE CATHETER TIP UPON REMOVAL. 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 12743860 ↗