Interlock™ M001361640Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 08714729765073), received between Dec 9, 2019 and Apr 24, 2026 — classified as 3 injuries, 20 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (9 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 24, 2026Break

  IT WAS REPORTED THAT COIL DETACHMENT OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 14MM X 30CM PE F-IDC COIL WAS SELECTED FOR USE. DURING ADVANCEMENT AND POSITIONING, THE CONNECTION BETWEEN THE COIL AND THE SHAFT WAS FRACTURED SUDDENLY AND THE COIL WAS DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24982890 ↗
• MalfunctionJun 26, 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 DEVICE ANALYSIS COMPLETED ON 29MAY2025. IT WAS REPORTED THAT THE COIL COULD NOT BE PUSHED OUT. THE PATIENT'S BLOOD VESSEL WAS TWISTED, AND THE SPLENIC ARTERY ANEURYSM WAS ABOUT 2CM IN DIAMETER. AFTER PLACING TWO COILS, THIS 14MM X 30CM INTERLOCK COIL WAS ADVANCED FOR 0.5CM. HOWEVER, IT COULD NO LONGER BE PUSHED OUT OF THE MICROCATHETER. IT WAS SUSPECTED THAT THE COIL WAS RELEASED FROM CATHETER. THE COIL AND THE DELIVERY CATHETER WERE WITHDRAWN FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT, AND PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341530 ↗
• MalfunctionDec 3, 2024Break; Difficult to Remove; Failure to Advance; Break; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE TIP WAS FRACTURED. THE TARGET LESION WAS LOCATED IN THE LOWER EXTREMITY VEINS. A 14MM X 30CM INTERLOCK COIL WAS SELECTED FOR ILIAC ANEURYSM EMBOLIZATION. DURING THE PROCEDURE, A 5F CATHETER WAS USED AND HEPARIN SALINE INFUSION WAS PERFORMED MANUALLY, AND THE FLUSHING WAS PERFORMED PRIOR TO COIL INTRODUCTION. HOWEVER, IT WAS NOTED THAT THE COIL COULD NOT BE ADVANCED INSIDE THE CATHETER DUE TO RESISTANCE. AFTER FORCED WITHDRAWAL, MANUAL HEPARIN SALINE INFUSION WAS PERFORMED AND THEN THE MICROCATHETER WAS RE-ENTERED, BUT THE COIL STILL COULD NOT BE ADVANCED. CONSEQUENTLY, IT WAS NOTED THAT THE TIP WAS FRACTURED UPON WITHDRAWAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20832950 ↗
• MalfunctionNov 26, 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 06NOV2024. IT WAS REPORTED THAT THE COIL FAILED TO ADVANCE IN CATHETER. A 14MM X 30CM INTERLOCK WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE OF ARTERIOVENOUS MALFORMATIONS OF THE UPPER AND LOWER EXTREMITIES. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE PUSHED IN VIVO. WHEN ATTEMPTED TO WITHDRAW FROM THE BODY, THE COIL WAS STILL UNABLE TO PUSH. 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 DETACHED MAIN COIL AND PUSHER WIRE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20789201 ↗
• MalfunctionNov 26, 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 TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND NON-CALCIFIED SPLENIC ARTERY. THE DIAMETER OF SPLENIC ANEURYSM WAS ABOUT 2 CM. A 14MM X 30CM INTERLOCK WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, THE PHYSICIAN COULD NOT SEND THE COIL OUT OF THE DISTAL PART OF THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THE PATIENT IS FINE, AND THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THE PUSHER WIRE WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20784794 ↗
• MalfunctionOct 8, 2024Premature 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 DEVICE ANALYSIS COMPLETED ON 17SEP2024. IT WAS REPORTED THAT THE COIL WAS STUCK AND PREMATURELY DEPLOYED IN THE MICROCATHETER. A 14MM X 30CM INTERLOCK COIL WAS SELECTED TO EMBOLIZE THE LEFT INTERNAL ILIAC BRANCH. BEFORE USING, THE COIL WAS FLUSHED AND WAS INJECTED CONTINUOUSLY WITH HEPARIN SALINE DURING THE PROCEDURE. HOWEVER, DURING ADVANCING, IT WAS NOTED THAT THE COIL COULD NOT EXTEND OUT THE MICROCATHETER EVEN AFTER SEVERAL ATTEMPTS. CONSEQUENTLY, THE COIL WAS AUTOMATICALLY RELEASED AND STUCK IN THE MICROCATHETER DURING WITHDRAWAL. 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 THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20396924 ↗
• MalfunctionAug 9, 2024Break; Difficult to Remove; Difficult to Advance; Break; Difficult to Remove; Difficult to Advance

  IT WAS REPORTED THAT COIL FRACTURE OCCURRED. THE TARGET LESION WAS LOCATED IN THE CELIAC TRUNK ANEURYSM. A 14MM X 30CM 2D INTERLOCK COIL WAS SELECTED FOR TREATMENT. DURING THE PROCEDURE, AN OBVIOUS RESISTANCE WAS FELT WHEN ADVANCING THE COIL. UPON WITHDRAWAL, THERE WAS ALSO RESISTANCE, AND THE BODY OF COIL WAS FOUND FRACTURED INSIDE THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS IN GOOD CONDITION AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19949934 ↗
• MalfunctionFeb 12, 2024Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 17-JAN-2024. IT WAS REPORTED THAT THE COIL WAS STUCK AFTER RELEASING HALFWAY THEN COULD NOT BE WITHDRAWN. THE TARGET LESION WAS LOCATED IN THE BRONCHUS. A 14MM X 30CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS STUCK WHEN RELEASED TO HALFWAY, COULD NOT BE ADVANCED NOR WITHDRAWN. THE COIL WAS REMOVED FORCIBLY OUT OF BODY WITH THE CATHETER. 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 COIL WAS DETACHED AT THE COIL ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18686652 ↗
• MalfunctionNov 15, 2023Entrapment of Device; Failure to Advance; Entrapment of Device; Failure to Advance

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER TIP UPON REMOVAL. THE TARGET LESION WAS IN THE SPLENIC ARTERY. A 14MM X 30CM PE F-IDC INTERLOCK WAS SELECTED FOR USE. DURING A SPLENIC ANEURYSM EMBOLIZATION PROCEDURE, AFTER THREE 14MMX30CM 18 SYSTEM COILS WERE DEPLOYED THIS DEVICE WAS USED. HOWEVER, IT WAS NOTED THAT THIS DEVICE COULD NOT BE PUSHED AT THE DISTAL END ABOUT 6-10CM FROM THE TIP OF THE MICROCATHETER AND PROTRUDED FROM THE CATHETER TIP UPON REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18141935 ↗
• MalfunctionNov 7, 2023Break; Separation Failure; Break; Separation Failure

  IT WAS REPORTED THAT THE COIL DETACHED. THE TARGET LESION WAS LOCATED IN THE PELVIC CAVITY. A 14MM X 30CM F-IDC 2D WAS SELECTED FOR PELVIC VEIN EMBOLIZATION. DURING THE PROCEDURE, A 5F IMAGING CATHETER WAS USED TO SUPER-SELECT THE LESION VIA THE OVARIAN VEIN, AND THE COIL WAS ADVANCED INTO PATIENT'S BODY ALONG THE IMAGING CATHETER AND TO THE PELVIC EMBOLIZATION POSITION, BUT COULD NOT DEPLOY WHEN THE DEVICE WAS DELIVERED. THE COIL WAS WITHDRAWN AND REMOVED COMPLETELY BUT IT WAS FOUND TO BE BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE AFTER THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18087935 ↗
• MalfunctionAug 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 INSIDE THE MICROCATHETER. THE TARGET LESION WAS LOCATED IN THE SPLEEN. A 14MM X 30CM INTERLOCK WAS SELECTED FOR EMBOLIZATION. DURING THE PROCEDURE, WHEN THE DEVICE WAS ADVANCED TO THE TAIL END OF THE COIL, IT WAS NOTED THAT THE COIL WAS STUCK INSIDE THE MICROCATHETER. 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 MIDDLE SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17482451 ↗
• InjuryNov 21, 2022Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT INSERTION DIFFICULTIES OCCURRED. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED INTERNAL ILLIAC ARTERY. A 14MM X 30CM INTERLOCK 2D COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS DIFFICULT TO INSERT. THE DEVICE WAS REMOVED BY SNARING FROM THE PATIENT'S BODY AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15835278 ↗
• MalfunctionOct 27, 2022Premature Activation; Difficult to Remove; Failure to Advance; Material Integrity Problem; Premature Activation; Difficult to Remove; Failure to Advance; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6)2022. IT WAS REPORTED THAT THE COIL COULD NOT BE PUSHED OUT OF THE CATHETER, WAS SELF-DEPLOYING IN THE SHEATH, WAS UNABLE TO FORM GOOD SHAPE AND THE LENGTH WAS MUCH LONGER THAN 30CM. THE TARGET LESION WAS LOCATED IN THE RIGHT RENAL ANEURYSM. A 14MM X 30CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THAT THE COIL COULD NOT BE PUSHED OUT OF THE CATHETER AND WAS SELF-DEPLOYING IN THE SHEATH. AFTER WITHDRAWN FROM THE BODY, IT WAS FOUND THAT THE COIL OUTSIDE THE BODY WAS UNABLE TO FORM GOOD SHAPE AND THE LENGTH WAS MUCH LONGER THAN 30CM. THE ENTIRE CATHETER WAS REMOVED 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 THERE WAS FIBER LOSS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15680703 ↗
• MalfunctionApr 6, 2022Entrapment of Device; Premature Activation; Entrapment of Device; Premature Activation

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER'S TIP. A 14MM X 30CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS DETACHED EARLY IN THE DISTAL PART OF THE CATHETER. THE COIL WAS REMOVED TOGETHER WITH THE CATHETER; HOWEVER, 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 Clinical Signs, Symptoms or Conditions

  MAUDE report 14022475 ↗
• MalfunctionJan 12, 2022Entrapment of Device; Difficult to Remove; Entrapment of Device; Difficult to Remove

  IT WAS REPORTED THAT THE COIL PROTRUDE FROM THE CATHETER TIP WHEN REMOVED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS INTERNAL ILIAC ARTERY. A 14MM X 30CM PE F-IDC INTERLOCK EMBOLICS 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, 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 13238586 ↗
• MalfunctionNov 10, 2021Premature Activation; Physical Resistance/Sticking; Premature Activation; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 28OCT2021. IT WAS REPORTED THAT THE SPRING COIL COULD NOT BE ADVANCE AND PREMATURELY DEPLOYED. THE TARGET LESION WAS LOCATED IN THE CELIAC AXIS. A 14MM X 30CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, MULTIPLE COILS WERE USED, THREE 10MMX30CM AND A 14MMX30CM ACCORDINGLY. HOWEVER, WHEN THE 14MMX30CM WAS DEPLOYED, IT WAS NOTED THAT THE SPRING COIL COULD NOT BE ADVANCED AND PREMATURELY RELEASED IN THE MICROCATHETER. THE DEVICE WAS SIMPLY PULLED OUT FROM THE PATIENT'S BODY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS GOOD POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT FIBER BUNDLES WERE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12788942 ↗
• MalfunctionAug 10, 2021Separation Failure; Physical Resistance/Sticking; Separation Failure; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22JUL2021. IT WAS REPORTED THAT THE COIL COULD NOT BE DELIVERED AND DEPLOYED. THE TARGET LESION WAS LOCATED IN THE ILIUM. A 14MM X 30CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE DELIVERED AND DEPLOYED. THE DEVICE WAS SIMPLY PULLED OUT AND THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WERE MISSING FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12303049 ↗
• MalfunctionJun 23, 2021Separation Failure; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking; Separation Failure; Material Integrity Problem; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTIC ANEURYSM. A 14MMX30CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE RELEASED THROUGH THE MICROCATHETER AND FAILED TO DEPLOY. THE COIL WAS SIMPLY PULLED OUT WITH MICROCATHETER AND THE PROCEDURE WAS CANCELLED. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE. IT WAS FURTHER REPORTED THAT ACCORDING TO PLAN, THE PHYSICIAN WAS READY TO DEPLOY 2 COILS. HOWEVER, DUE TO THE ISSUE NOTED ON THE SECOND COIL, ONLY ONE COIL WAS ACTUALLY DEPLOYED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12053978 ↗
• MalfunctionNov 10, 2020Premature Activation; Premature Activation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 02NOV2020. IT WAS REPORTED THAT THE COIL DETACHED PREMATURELY INSIDE THE CATHETER. THREE INTERLOCK COILS OF DIFFERENT SIZES, NAMELY, TWO 18MMX50CM AND ONE 14MMX30CM, WERE SELECTED FOR USE ON THE PULMONARY ARTERY ANEURYSM. DURING THE PROCEDURE, AFTER FRAMING WITH 5 TARGETS, TWO 18MMX50CM INTERLOCK COILS WERE INSERTED. HOWEVER, IT WAS NOTED THAT BOTH COILS DETACHED PREMATURELY INSIDE THE CATHETER. THEN, ANOTHER COIL OF UNKNOWN SIZE WAS INSERTED AND DEPLOYED SUCCESSFULLY. THEN, THIS COIL WAS INSERTED. HOWEVER, IT WAS NOTED THAT THE COIL ALSO DETACHED PREMATURELY INSIDE THE CATHETER. THE COILS THAT DETACHED PREMATURELY WERE REMOVED WITH THE CATHETER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. IT WAS NOTED THAT THE COILS THAT DETACHED PREMATURELY DID NOT PROTRUDE IN THE CATHETER'S TIP DURING REMOVAL. NO COMPLICATIONS WERE REPORTED AND THERE WAS NO PATIENT INJURY. HOWEVER, DEVICE ANALYSIS REVEALED MISSING COIL FIBER BUNDLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10817449 ↗
• MalfunctionAug 4, 2020Component Missing; Material Deformation; Component Missing; Material Deformation

  IT WAS REPORTED THAT THERE WAS NO COIL FOUND UPON RETRIEVAL. THE TARGET LESION AREA WAS LOCATED IN THE SPLENIC ARTERY. A 14MM X 30CM INTERLOCK PE F-IDC WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE MICRO CATHETER REACHED THE LESION THEN THE PHYSICIAN CONNECTED THE COIL DELIVERY SHEATH AND THE MICRO CATHETER. THE GUIDEWIRE WAS ADVANCED INTO THE MICRO CATHETER BUT FAILED TO PUSH THE GUIDEWIRE AFTER ABOUT 10CM SO THE PHYSICIAN RETRIEVED THE COIL, BUT THERE WAS NO COIL FOUND. THE PHYSICIAN DID NOT CHECK THE COIL BEFORE THE PROCEDURE AND IT WAS CONFIRMED THAT THE COIL WAS NOT LEFT INSIDE THE PATIENT'S BODY. THE INTERLOCKING DETACHABLE ARMS WERE KINKED. THERE WAS NO COIL INSIDE THE MICRO CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10364298 ↗
• InjuryJun 3, 2020Premature Activation; Migration; Premature Activation; Migration

  IT WAS REPORTED THAT COIL MIGRATED OUTSIDE OF THE RENAL ARTERY AND WAS REMOVED WITH A GRIPPER. A 14MMX30CM INTERLOCK COIL WAS SELECTED FOR USE IN A RENAL ANEURYSM. DURING PROCEDURE, THE COIL RELEASED HALFWAY AND SLIPPED OUT OF THE RENEGADE STC 18 MICROCATHETER INTO THE PATIENT'S RENAL ARTERY. WHEN CONFIRMING THE COIL POSITION DURING ANGIOGRAPHY, IT WAS FOUND THAT THE COIL WAS OUTSIDE THE PATIENT'S RENAL ANEURYSM. THE MICROCATHETER WAS WITHDRAWN, THE 6F NON BSC SHEATH WAS REPLACED, AND THE COIL WAS COMPLETELY REMOVED FROM THE PATIENT'S BODY USING A GRIPPER. THE PROCEDURE WAS COMPLETED WITH ADDITIONAL COILS. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Code Available

  MAUDE report 10116943 ↗
• InjuryDec 10, 2019Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED THROMBUS FORMATION. THE TARGET LESION WAS LOCATED IN A RENAL ARTERY. A 14MM X 30CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE PHYSICIAN ADVANCED AND ADJUSTED THE COIL INTO THE TUMOR, IT WAS NOTED THAT A THROMBUS FORMED AND BECAME STUCK IN THE NON-BSC MICROCATHETER. FURTHERMORE, THE COIL COULD NOT BE DEPLOYED. THE COIL WAS REMOVED WITH THE CATHETER FROM THE PATIENT WITHOUT ANY INTERVENTIONS AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Thrombosis

  MAUDE report 9444450 ↗
• MalfunctionDec 9, 2019Entrapment of Device; Entrapment of Device

  REPORTED BASED ON THE DEVICE ANALYSIS COMPLETED ON 25NOV2019. A 14MM X 30CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS STUCK IN THE MICROCATHETER AND COULD NOT GET OUT. THE COIL WAS REMOVED FROM THE PATIENT'S BODY WITH THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WAS A MISSING FIBER BUNDLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9438029 ↗