Interlock™ M001361570Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 08714729765004), received between Oct 24, 2018 and Mar 31, 2026 — classified as 10 injuries, 36 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (14 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 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Stretched; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS ON 27FEB2026. IT WAS REPORTED THAT THE COIL COULD NOT ADVANCE IN THE MICROCATHETER. THE PATIENT UNDERWENT TRANSCATHETER EMBOLIZATION OF A SPLENIC ANEURYSM UNDER LOCAL ANESTHESIA. THE TARGET LESION WAS LOCATED IN THE LEFT FEMORAL ARTERY. AN STC MICROCATHETER AND 18 CONTROLLABLE COILS WERE UTILIZED FOR EMBOLIZATION. THE INITIAL COILS, 14 MM X 30 CM, 12 MM X 30 CM, AND 10 MM X 30 CM WERE DELIVERED WITHOUT DIFFICULTY. HOWEVER, THE FINAL 6 MM X 20 CM CONTROLLABLE COIL WAS ADVANCED INTO THE MICROCATHETER AND BECAME STUCK. DESPITE REPEATED ATTEMPTS, ADVANCEMENT WAS UNSUCCESSFUL, AND THE COIL WAS SUBSEQUENTLY WITHDRAWN. UPON INSPECTION, THE CONTROLLABLE COIL WAS NOTED TO BE STRETCHED. A SECOND 6 MM X 20 CM CONTROLLABLE COIL WAS THEN SELECTED AND DELIVERED USING THE SAME STC BOSTON SCIENTIFIC MICROCATHETER. THIS COIL WAS DEPLOYED WITHOUT DIFFICULTY, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT WAS STABLE POST-PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE COIL ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24741140 ↗
• MalfunctionDec 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 08NOV2025. IT WAS REPORTED THAT THE COIL WAS UNABLE TO ADVANCE IN THE INTRODUCER SHEATH. A 6MM X 20CM INTERLOCK COIL WAS SELECTED FOR SPLENIC ARTERY EMBOLIZATION. DURING THE PROCEDURE, THE COIL WAS UNABLE TO PUSH THROUGH THE INTRODUCER SHEATH DUE TO HIGH RESISTANCE. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE METHOD. THERE WERE NO PATIENT COMPLICATION AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTRODUCER SHEATH WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23720650 ↗
• MalfunctionAug 29, 2025Stretched; 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 THE DEVICE ANALYSIS COMPLETED ON 04AUG2025. IT WAS REPORTED THAT THE COIL WAS STUCK IN THE CATHETER. A 6MM X 20CM INTERLOCK DEVICE WAS SELECTED FOR USE IN A SPLENIC ARTERY ANEURYSM EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, WHEN ATTEMPTING TO PLACE THIS INTERLOCK COIL, THE COIL BECAME STUCK IN THE BOSTON SCIENTIFIC CATHETER AND COULD NOT BE ADVANCED. THE DEVICE WAS THEN WITHDRAWN, AT WHICH TIME THE COIL WAS OBSERVED TO BE STRETCHED. BOTH THE COIL AND THE MICROCATHETER WERE REMOVED TOGETHER FROM THE PATIENT'S BODY, AND THE PROCEDURE WAS COMPLETED USING WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION WAS STABLE FOLLOWING THE PROCEDURE. HOWEVER, ANALYSIS OF THE RETURNED DEVICE REVEALED THE MAIN COIL WAS DETACHED AT THE COIL ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22923313 ↗
• InjuryJun 26, 2025Difficult to Remove; Stretched; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; Stretched; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COIL UNRAVELED IN THE BODY, REQUIRING INTERVENTION. A 6MM X 20CM INTERLOCK COIL WAS ADVANCED FOR ENDOVASCULAR ANEURYSM REPAIR PROCEDURE OF THE INFERIOR MESENTERIC ARTERY. WHEN ATTEMPTING TO RETRIEVE THE COIL THAT WAS INTENDED TO BE PLACED, A RESISTANCE WAS ENCOUNTERED, AND THE COIL BECAME DAMAGED; IT UNRAVELED IN THE BODY. THERE WAS NO DETACHMENT NOTED. THE COIL WAS ATTEMPTED TO BE REMOVED ALONG THE WITH THE CATHETER; HOWEVER, IT WAS THEN RETRIEVED USING A SNARE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT'S CONDITION WAS GOOD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22341839 ↗
• MalfunctionMay 28, 2025Difficult to Insert; Adverse Event Without Identified Device or Use Problem; Difficult to Insert; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30APR2025. IT WAS REPORTED THAT THE COIL COULD NOT BE DELIVERED. THE TARGET LESION WAS LOCATED IN THE HEPATIC ARTERY. A 6MM X 20CM INTERLOCK COIL WAS ADVANCED FOR TREATMENT. HOWEVER, THE COIL BECAME STUCK AT THE OPENING OF THE 2.6 NON-BOSTON SCIENTIFIC CATHETER AND COULD NOT BE DELIVERED OUT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. 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 AND ARM COIL WERE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22099436 ↗
• MalfunctionApr 25, 2025Difficult to Insert; Adverse Event Without Identified Device or Use Problem; Difficult to Insert; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2025. IT WAS REPORTED THAT THE DIFFICULTY INSERTION OCCURRED. THE TARGET LESION WAS LOCATED IN THE ARTERIOVENOUS MALFORMATION. A 6MM X 20CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE INSERTED INTO THE DELIVERY 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 THAT THE ARM COIL AND THE ZAP TIP WERE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21911539 ↗
• InjuryNov 5, 2024Entrapment of Device; Difficult to Remove; Stretched; Failure to Advance; Malposition of Device; Entrapment of Device; Difficult to Remove; Stretched; Failure to Advance; Malposition of Device

  IT WAS REPORTED THAT THE DEVICE GOT STUCK IN THE MICROCATHETER AND STRETCHED, REQUIRING ADDITIONAL INTERVENTION. THE HEMOSTASIS OF RIGHT INTERNAL ILIAC HEMORRHAGE HAS BEEN ACHIEVED WITH COIL EMBOLIZATION VIA LEFT FEMORAL APPROACH. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED RIGHT INTERNAL ILIAC. A 6MM X 20CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL GOT STUCK AT THE TIP OF A NON - BOSTON SCIENTIFIC MICROCATHETER AND WAS UNRAVELED WHEN PULLED. THE MICROCATHETER WAS REMOVED AND LEFT THE COIL IN THE NON - BOSTON SCIENTIFIC GUIDING CATHETER. THE REMAINING COIL WAS PUSHED WITH THE SHEATH DILATOR; HOWEVER, IT DID NOT MOVE. EVENTUALLY, THE GROIN WAS INCISED, AND THE COIL WAS CUT PARTWAY THROUGH, AND THE REMAINDER WAS LEFT IN THE BODY. THE REMAINING PART WAS LEFT IN AN UNINTENDED LOCATION. THE MICROCATHETER WAS REPLACED WITH ANOTHER OF THE SAME DEVICE AND AN 8MM X 20CM INTERLOCK WAS PLACED AGAIN, BUT THE SAME ISSUE OCCURRED. THE USER TRIED LEAVING THE COIL IN THE DESTINATION AND PUSHING IT WITH THE SHEATH DILATOR, BUT THIS WAS NOT POSSIBLE. THE SYSTEM WAS REMOVED, AND THE REMAINING COIL WAS CUT THROUGH AN INCISION IN THE INGUINAL REGION.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20615176 ↗
• MalfunctionJul 18, 2024Break; Break

  IT WAS REPORTED THAT A CATHETER BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 6MM X 20CM INTERLOCK COIL WAS SELECTED FOR ENDOVASCULAR ANEURYSM REPAIR (EVAR). DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL HAD SEPARATED WHEN IT WAS ADVANCED THROUGH THE CATHETER AND ATTEMPTED TO BE TAKEN OUT. THE ENTIRE CATHETER WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19778234 ↗
• MalfunctionJul 3, 2024Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6)2024. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED IN THE CATHETER AND COULD NOT BE WITHDRAWN. THE TARGET LESION WAS LOCATED IN A TRANSJUGULAR INTRAHEPTIC PORTOSYSTEMIC SHUNT (TIPS) IN THE MILDLY TORTUOUS FUNDUS GASTRIC VEIN. A 6MM X 20CM AND 8MM X 20CM INTERLOCK COILS WERE USED. DURING THE PROCEDURE, HEPARIN SALINE WAS CONTINUOUSLY INJECTED. AFTER EACH COIL WAS INTRODUCED INTO A 2.7FR MICROCATHETER, IT COULD NOT BE ADVANCED IN AFTER CROSSING THE MIDLINE AND COULD NOT BE WITHDRAWN FROM THE MICROCATHETER. THE COILS REMOVED TOGETHER WITH THE CATHETER. THE PROCEDURE WAS COMPLETED WITH NEW 6MM X 20CM AND 8MM X 20CM COILS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT STATUS WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE COIL ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19667188 ↗
• MalfunctionMay 17, 2024Premature Activation; Premature Activation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24APR2024. IT WAS REPORTED THAT PREMATURE DEPLOYMENT INSIDE THE CATHETER OCCURRED. THE TARGET LESION WAS LOCATED IN THE ILIAC ARTERY. A 6MM X 20CM INTERLOCK WAS SELECTED FOR EMBOLIZATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS DISCONNECTED INSIDE THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST-PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THE INTERLOCKING ARM OF THE COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19346845 ↗
• InjuryApr 15, 2024Break; Premature Activation; Failure to Advance; Break; Premature Activation; Failure to Advance

  IT WAS REPORTED THAT COIL BREAK OCCURRED AND PART OF IT REMAINED INSIDE THE BODY. THE TARGET LESION WAS LOCATED IN A MODERATELY TORTUOUS AND MILDLY CALCIFIED LESION. A 6MM X 20CM INTERLOCK WAS SELECTED FOR USE IN A SPLENIC ARTERY EMBOLIZATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS UNHOOKED IN THE MICROCATHETER, AND THE MICROCATHETER COULD NOT BE COMPLETELY PUSHED OUT. A PART OF THE COIL REMAINED IN THE BODY AND ATTEMPTS TO GRASP IT WERE UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 19110345 ↗
• InjuryMar 21, 2024Premature Activation; Failure to Advance; Positioning Problem; Premature Activation; Failure to Advance; Positioning Problem

  IT WAS REPORTED THAT THE COIL WAS REMOVED WITH A SNARE. THE TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS INFERIOR MESENTERIC ARTERY. AFTER PLACING A RENEGADE STC-18 MICROCATHETER, A 6MM X 20CM INTERLOCK WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, THE COIL WAS NOT PUSHED SMOOTHLY, AND THE CATHETER POPPED OUT AFTER THE OBSTRUCTION RESULTING IN THE DETACHMENT OF THE COIL INSIDE THE PATIENT. THE COIL WAS REMOVED WITH A SNARE. A 35-SYSTEM, 8MM X 40CM INTERLOCK WITH A 5F NON-BOSTON SCIENTIFIC ANGIOGRAPHIC CATHETER WERE SELECTED FOR EMBOLIZATION AND REDUCTION. THE ANGIOGRAPHY WAS NORMAL, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18952143 ↗
• MalfunctionDec 11, 2023Stretched; Failure to Advance; Stretched; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED IN CATHETER AND WAS STRETCHED. A 6MM X 20CM F-IDC 2D INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, THE MICROCATHETER COULD NOT BE ADVANCED AFTER REPEATED ADJUSTMENT. AFTER THE COIL WAS WITHDRAWN, IT WAS FOUND THAT THE COIL WAS STRETCHED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THE DETACHED MAIN COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18307174 ↗
• MalfunctionOct 30, 2023Failure to Advance; Material Integrity Problem; Failure to Advance; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09OCT2023. IT WAS REPORTED THAT THE COIL WAS UNABLE TO ADVANCE IN THE CATHETER AND DAMAGE OCCURRED. THE TARGET LESION WAS LOCATED IN THE INTRAHEPATIC PORTAL VEIN. A 6MM X 20CM INTERLOCK WAS SELECTED FOR USE. DURING THE TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) PROCEDURE, A 0.020 NON-BOSTON SCIENTIFIC MICROCATHETER WAS USED TO DEPLOY 5 COILS. THE SECOND COIL WAS DELIVERED APPROXIMATELY 5CM OUT FROM THE CATHETER AND DURING DEPLOYMENT IN THE SHUNT, IT WAS NOTED THAT THE COIL WAS STUCK IN THE MIDDLE OF THE CATHETER. THE COIL COULD BE PULLED BACK BUT COULD NOT BE ADVANCED FORWARD. DESPITE MULTIPLE ATTEMPTS, IT COULD NOT BE DELIVERED. AFTER REMOVAL OF THE COIL, IT WAS NOTED THAT THE INTERLOCK WAS DAMAGED. 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 THE MAIN COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18030973 ↗
• MalfunctionAug 22, 2023Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 31 JUL 2023. IT WAS REPORTED THAT THE COIL COULD NOT BE PUSHED OUT FROM THE MICROCATHETER. THE TARGET LOCATION WAS IN THE GASTRIC VARICES. A 6MM X 20CM PE F-IDC COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE PUSHED OUT FROM THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT 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 17599730 ↗
• InjuryAug 4, 2023Entrapment of Device; Premature Activation; Entrapment of Device; Premature Activation

  IT WAS REPORTED THAT COIL DETACHMENT OCCURRED REQUIRING SNARING FOR REMOVAL. A 6MM X 20CM INTERLOCK COIL WAS SELECTED FOR EMBOLIZATION OF HEPATIC ARTERY. DURING THE PROCEDURE, RIGHT HEPATIC EMBOLIZATION WAS PLANNED FOR THE PATIENT, BUT THE COIL WENT TO GASTRODUODENAL ARTERY (GDA). RESHEATHING WAS DONE INSIDE THE MICROCATHETER, BUT THE COIL HAS DETACHED INSIDE THE MICROCATHETER FROM DELIVERY WIRE. SNARE WAS USED TO REMOVE THE COIL FROM GDA, AS 95% OF THE COIL WAS IN PATIENT BODY AND ONLY 5% WAS IN THE MICROCATHETER. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE DEVICE AND NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17460227 ↗
• MalfunctionJul 13, 2023Failure to Advance; Separation Failure; Failure to Advance; Separation Failure

  REPORTABLE BASED ON DEVICE INVESTIGATION COMPLETED ON 20JUN2023. IT WAS REPORTED THAT THE COIL GOT STUCK IN THE CATHETER. THE TARGET LESION WAS IN THE LOWER LIMB ARTERY. A 6MM X 20CM INTERLOCK PE F-IDC WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THIS DEVICE WAS ADVANCED SMOOTHLY BUT COULD NOT BE RELEASED. HENCE, THE COIL GOT STUCK IN THE DISTAL PART OF THE CATHETER. THE COIL WAS RETRACTED INSIDE THE CATHETER AGAIN TO REMOVE AND THE ENTIRE SYSTEM WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE. HOWEVER, DEVICE INVESTIGATIONS REVEALED THAT THE INTRODUCER WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17321679 ↗
• MalfunctionJun 9, 2023Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED/RESCHEDULED. THE TARGET LESION WAS LOCATED IN THE CORONARY ARTERIO-PULMONARY ARTERY FISTULA. A 6MM X 20CM PE F-IDC COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE RELEASED WHEN ADVANCED OUT OF THE MICROCATHETER. THE PHYSICIAN MADE MULTIPLE ATTEMPTS HOWEVER, THE DEVICE STILL COULD NOT BE RELEASED AND HAD TO BE WITHDRAWN FROM THE PATIENT. THE PROCEDURE WAS RESCHEDULED THREE DAYS LATER AND WAS COMPLETED SUCCESSFULLY WITH DEVICE RELEASED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17100392 ↗
• MalfunctionDec 13, 2022Difficult to Remove; Stretched; Failure to Advance; Difficult to Remove; Stretched; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15NOV2022. IT WAS REPORTED THAT THE COIL WAS UNABLE TO ADVANCE IN THE INTRODUCER SHEATH AND WAS STRETCHED. THE TARGET LESION WAS LOCATED IN THE GASTRIC VENOUS. A 6MM X 20CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS UNABLE TO ADVANCE IN THE INTRODUCER SHEATH AND IT WAS STRETCHED. 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 THE PUSHER WIRE WAS DETACHED/SEPARATED AT MID SOLDER JOINT SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15973533 ↗
• InjuryDec 1, 2022Migration; Migration

  IT WAS REPORTED THAT THE COIL PACK MIGRATED. A 6MM X 20CM 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 15901003 ↗
• InjuryDec 1, 2022Migration; Migration

  IT WAS REPORTED THAT THE COIL PACK MIGRATED. A 6MM X 20CM 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 15898503 ↗
• MalfunctionOct 2, 2022Entrapment 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 LOCATED IN THE MODERATELY TORTUOUS AND NON-CALCIFIED INFERIOR MESENTERIC ARTERY. A 6MM X 20CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK IN THE DISTAL PART OF A NON-BOSTON SCIENTIFIC CATHETER. THE COIL PROTRUDED FROM THE TIP OF THE CATHETER UPON REMOVAL. 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 15526169 ↗
• MalfunctionSep 7, 2022Entrapment 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 MODERATELY INFERIOR MESENTERIC ARTERY. A 6MM X 20CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK IN THE DISTAL PART OF 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 0.021-INCH NON-BOSTON SCIENTIFIC MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED POST PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15375315 ↗
• MalfunctionMay 10, 2022Stretched; Failure to Advance; Stretched; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 19-APR-2022. IT WAS REPORTED THAT THE COIL COULD NOT BE DELIVERED AND WAS STRETCHED. THE TARGET LESION WAS LOCATED IN THE RENAL ARTERY. A 6MM X 20CM INTERLOCK COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, A MICROCATHETER WAS USED TO DEPLOY A 10MMX20CM AND A 8MMX20CM 18-COIL AND BOTH WERE DEPLOYED NORMALLY. HOWEVER, WHEN THE 6MM X 20CM COIL WAS DEPLOYED, IT COULD NOT BE DELIVERED FROM THE CATHETER. AFTER REPEATED ATTEMPTS, THE COIL WAS SLOWLY PULLED OUT AND WAS FOUND TO BE STRETCHED AND DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE INTERLOCKING ARM GOT DETACHED AND THERE WERE MISSING FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14345318 ↗
• MalfunctionMar 29, 2022Separation Failure; Separation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 08MAR2022. IT WAS REPORTED THAT THE COIL WAS FAILED TO DEPLOY. THE TARGET LESION WAS LOCATED IN THE LUNG. A 6MM X 20CM INTERLOCK WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WERE MISSING FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13945603 ↗