Interlock™-35 M001363670Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 08714729795414), received between Sep 17, 2018 and Jan 26, 2026 — classified as 3 injuries, 30 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (12 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 33 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 26, 2026Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30DEC2025. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED FROM THE CATHETER. AN 18MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE ADVANCED FROM THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A NON-BOSTON SCIENTIFIC DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED A DETACHED ARM COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24179118 ↗
• InjuryJan 20, 2026Break; Failure to Advance; Material Protrusion/Extrusion

  IT WAS REPORTED THAT COIL PROTRUDING OCCURRED REQUIRING INTERVENTION. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 18MM X 40CM INTERLOCK?-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT COIL COULD NOT CONTINUE TO ADVANCE NORMALLY AFTER MULTIPLE ATTEMPTS, AND REPEATED ATTEMPTS STILL FAILED TO ADVANCE. UPON WITHDRAW, IT WAS NOTED THE COIL TAIL REMAINED (ACROSS THE LEFT INTERNAL ILIAC ARTERY-LEFT COMMON ILIAC ARTERY-RIGHT COMMON ILIAC ARTERY), AND THEN THE COIL WAS RETRIEVED USING A CATCHER OUT OF THE PATIENT'S BODY. 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 24125565 ↗
• MalfunctionJan 16, 2026Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18DEC2025. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED FROM THE CATHETER. THE TARGET LESION WAS LOCATED IN THE TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT. AN 18MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS DEPLOYED APPROXIMATELY 15 CM. HOWEVER, IT BECAME STUCK AND COULD NOT BE ADVANCED FURTHER OUT OF THE CATHETER DESPITE MULTIPLE ATTEMPTS. 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 A DETACHED, BENT AND STRETCHED COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24094937 ↗
• MalfunctionJan 12, 2026Nonstandard Device; Premature Activation; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18DEC2025. IT WAS REPORTED THAT UNABLE TO ADVANCE AND PREMATURE DEPLOYMENT OCCURRED. THE PATIENT WAS TREATED WITH GASTRIC VARICES EMBOLIZATION IN THE LOWER PART OF THE ESOPHAGUS. A 18MM X 40CM INTERLOCK .035 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL WAS EMBOLIZED IN THE LESION LUMEN. UPON ENTERING THE MIDDLE PART OF THE NON-BOSTON SCIENTIFIC RADIOGRAPHY CATHETER, IT WAS NOTED THAT THE COIL COULD NOT BE PUSHED FORWARD IN THE CATHETER. AFTER WITHDRAWAL, THE COIL WAS UNHOOKED AND DAMAGED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A MAIN COIL DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24048077 ↗
• InjuryNov 5, 2025Malposition of Device; Positioning Problem; Migration; Malposition of Device; Positioning Problem; Migration

  IT WAS REPORTED THAT COIL MIGRATION OCCURRED REQUIRING ADDITIONAL INTERVENTION. A NON-STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND NON-CALCIFIED ABDOMINAL AORTA. AN 18MM X 40CM INTERLOCK-35 WAS SELECTED FOR ENDOVASCULAR ANEURYSM REPAIR. DURING THE PROCEDURE, A CATHETER KICKBACK OCCURRED DUE TO SEVERE TORTUOSITY DURING THE CONTRALATERAL APPROACH. CONSEQUENTLY, THE COIL WAS DETACHED PREMATURELY AND UNINTENTIONALLY PLACED IN THE UNINTENDED SITE. THE COIL PROTRUDED INTO THE COMMON ILIAC ARTERY AND WAS SEALED WITH A STENT GRAFT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23478107 ↗
• MalfunctionSep 18, 2025Premature Activation; Adverse Event Without Identified Device or Use Problem; Premature Activation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 21AUG2025. A 18MM X 40CM INTELOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, A CONTINUOUS FLUSHING WAS DONE BEFORE INTRODUCTION OF COIL. SUBSEQUENTLY, THE COIL GOT DETACHED INSIDE THE 5F DELIVERY CATHETER. THE PROCEDURE WAS COMPLETED USING AN ALTERNATIVE DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE MAIN COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085688 ↗
• MalfunctionAug 15, 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 22JUL2025. IT WAS REPORTED THAT THE COIL WAS STUCK AND COULD NOT MOVE FORWARD. A 18MM X 40CM INTERLOCK-35 COIL WAS ADVANCED TO EMBOLIZE THE ABDOMINAL AORTIC ANEURYSM. DURING DELIVERY OF THE COIL THROUGH THE CATHETER, THE COIL COULD NOT MOVE FORWARD. IT WAS THEN WITHDRAWN, AND WAS DELIVERED AGAIN; BUT THE COIL WAS STILL STUCK AT THE ORIFICE OF THE CATHETER AND COULD NOT MOVE FORWARD. THE WHOLE SET WAS REMOVED AND REPLACED IT WITH A NEW 18MM X 40CM INTERLOCK-35 COIL. THE PROCEDURE WAS COMPLETED AND THERE WAS NO PATIENT COMPLICATIONS NOTED AS A RESULT OF THIS EVENT. THE PATIENT CONDITION FOLLOWING PROCEDURE WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE COIL ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22816656 ↗
• MalfunctionAug 7, 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 10JUL2025. IT WAS REPORTED THAT THE COIL WAS UNABLE TO ADVANCE IN THE CATHETER. A 18MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE, DURING THE COURSE OF THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT CROSS THE SUBSEQUENT DEVICE. 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 COIL DETACHED AT THE COIL ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738808 ↗
• MalfunctionJul 10, 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 THE DEVICE ANALYSIS COMPLETED IN 12JUN2025. IT WAS REPORTED THAT THE COIL WAS UNABLE TO ADVANCE. THE STENOSED TARGET LESION WAS LOCATED IN THE AORTA. A 18MM X 40CM INTERLOCK DEVICE WAS SELECTED FOR USE. DURING THE PROCEDURE, MULTIPLE ATTEMPTS WERE MADE TO ADVANCE THE COIL THROUGH THE CATHETER; HOWEVER, THE COIL FAILED TO EXIT THE CATHETER AS INTENDED. THE PROCEDURE WAS COMPLETED USING WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED MAIN COIL DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22472915 ↗
• MalfunctionApr 4, 2025Difficult to Remove; Stretched; Difficult to Advance; Difficult to Remove; Stretched; Difficult to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11MAR2025. IT WAS REPORTED THAT THE COIL WAS STRETCHED. A 18MM X 40CM 2D INTERLOCK-35 COIL WAS SELECTED FOR USE IN A HEPATIC ARTERIOGRAPHY AND TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE. THE TARGET LOCATION WAS IN THE GASTRIC VARICES. DURING THE PROCEDURE, A RESISTANCE OCCURRED WHEN DELIVERING THE COIL, AND THE COIL COULD NOT BE WITHDRAWN. THE COIL WAS THEN REMOVED WITH THE 5F NON-BOSTON SCIENTIFIC CONTRAST CATHETER. UPON REMOVAL, THE COIL WAS FOUND TO BE STRETCHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS AS A RESULT OF THIS EVENT, AND THE PATIENT WAS IN STABLE CONDITION FOLLOWING THE PROCEDURE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE ARM OF THE COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21775352 ↗
• MalfunctionDec 10, 2024Failure to Advance; Difficult to Advance; Adverse Event Without Identified Device or Use Problem; Failure to Advance; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25NOV2024. IT WAS REPORTED THAT THE COIL COULD NOT ADVANCE IN THE CATHETER. THE PATIENT DIAGNOSED WITH A LEFT COMMON ILIAC ARTERY ANEURYSM, UNDERWENT TREATMENT WITH ENDOVASCULAR STENT-GRAFT REPAIR. AN 18MM X 40CM INTERLOCK-35 COIL AND A NON-BOSTON SCIENTIFIC (BSC) CATHETER WAS SELECTED FOR EMBOLIZATION. HOWEVER, DURING THE PROCEDURE, THE PHYSICIAN FELT SIGNIFICANT RESISTANCE WHEN DEPLOYING THE COIL. AFTER SEVERAL ATTEMPTS, THE CATHETER WAS REPLACED BUT THE COIL COULD STILL NOT BE PUSHED OUT. THE DEVICE WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20894380 ↗
• MalfunctionJul 2, 2024Stretched; Failure to Advance; Stretched; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 07JUN2024. IT WAS REPORTED THAT THE COIL WAS STUCK AND WAS STRETCHED. AN 18MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE TO TREAT GASTRIC FUNDUS VENOUS BLEEDING. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS STUCK AND COULD NOT BE ADVANCED FORWARD. THE COIL WAS PULLED OUT OF THE CATHETER, AND IT WAS NOTED THAT THE COIL WAS STRETCHED. NO COMPLICATIONS WERE REPORTED, AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19661261 ↗
• MalfunctionNov 9, 2023Break; Difficult to Remove; Failure to Advance; Break; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE INTERLOCK ARM WAS FRACTURED. THE NON-STENOSED TARGET LESION WAS IN THE S-SHAPED TORTUOUS AND NON-CALCIFIED SPLENIC ARTERY. A 18MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE IN PERCUTANEOUS ARTERIAL EMBOLIZATION PROCEDURE. DURING DELIVERY, IT WAS NOTED THAT THE COIL COULD NOT BE PUSHED OR WITHDRAW AT THE END OF THE 5F ULTRASOUND CATHETER. CONSEQUENTLY, AFTER SEVERAL ATTEMPTS THE INTERLOCK ARM OF THE PUSHER WIRE FRACTURED. THE PHYSICIAN THEN TRIED TO PUSH THE COIL OUTSIDE THE BODY WITH 0.035 HYDROPHILIC GUIDEWIRE BUT FAILED. THE COIL NEVER ENTERED THE PATIENT, AND REMAINED IN THE CATHETER THE ENTIRE TIME. 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 18102662 ↗
• MalfunctionSep 22, 2023Premature Activation; Adverse Event Without Identified Device or Use Problem; Premature Activation; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 04SEP2023. IT WAS REPORTED THAT THE COIL RELEASED INSIDE THE CATHETER. THE TARGET LESION WAS LOCATED IN THE SPLEEN. A 18MM X 40CM .035 INTERLOCK 2D WAS SELECTED FOR USE. DURING PROCEDURE, WHEN THE IMAGING CATHETER WAS USED TO DEPLOY THE COIL, THE COIL RELEASED INSIDE THE ANGIOGRAPHIC CATHETER. THE DEVICE WAS REMOVED WITH THE CONTRAST CATHETER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER COIL. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. 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 17799900 ↗
• MalfunctionAug 23, 2023Premature Activation; Premature Activation

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 31JULY2023. IT WAS REPORTED THAT THE DEVICE WAS PREMATURELY DEPLOYED INSIDE THE CATHETER. THE TARGET LESION WAS LOCATED IN THE ESOPHAGEAL GASTRIC VARICES. A .035 INTERLOCK 2D 18MM X 40CM COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN THE COIL WAS TO BE DEPLOYED WITH AN ANGIOGRAPHY CATHETER, IT WAS DIRECTLY DEPLOYED INSIDE THE CATHETER. AS A RESULT, A NEW CATHETER WAS USED. NO COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE. 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 17607443 ↗
• MalfunctionJun 16, 2023Break; Break

  IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. A 18MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE DEVICE WAS FRACTURED. THE DEVICE WAS SIMPLY PULLED OUT FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER INTERLOCK. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17145104 ↗
• MalfunctionMay 16, 2023Difficult to Remove; Failure to Advance; Material Integrity Problem; Difficult to Remove; Failure to Advance; Material Integrity Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2023. IT WAS REPORTED THAT THE COIL WAS DAMAGED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS VESSEL. AN 18MMX40CM INTERLOCK-35 COIL WAS SELECTED FOR USE. DURING THE PROCEDURE, WHEN TRYING THE PLACEMENT POSITION FOR SEVERAL TIMES, IT WAS NOTED THAT THE COIL WAS DAMAGED AT THE DISTAL PART INSIDE THE CATHETER. SINCE IT WAS A LONG COIL, IT GOT CAUGHT WHEN IT WAS EXTENDED AND RETRACTED. THE COIL WAS REMOVED TOGETHER WITH THE CATHETER FROM THE PATIENT AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT INJURY. 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 16941680 ↗
• MalfunctionAug 27, 2022Difficult to Remove; Separation Failure; Difficult to Remove; Separation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS RECEIVED ON (B)(6) 2022. IT WAS REPORTED THAT HIGH RESISTANCE WAS NOTED WHILE ATTEMPTING TO DEPLOY THE COIL. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. AN 18MMX40CM AND 20MMX40CM INTERLOCK-35 WERE SELECTED FOR USE. DURING THE PROCEDURE, HIGH RESISTANCE WAS ENCOUNTERED WHEN DEPLOYING THE 18MMX40CM COIL WITH THE HELP OF A 5F CATHETER. IT WAS THEN WITHDRAWN AND PULLED BACK TO THE SHEATH AND FOUND THAT IT COULD NOT BE DEPLOYED. THE ENTIRE CATHETER WAS REMOVED. THE COIL WAS REPLACED, BUT THE SAME ISSUE OCCURRED WITH THE 20MMX40CM COIL. 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 INTERLOCKING ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15307767 ↗
• MalfunctionAug 18, 2022Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 27JUL2022. IT WAS REPORTED THAT THE DEVICE WAS STUCK IN THE CATHETER. THE TARGET LESION WAS IN THE INTERNAL ILIAC ARTERY. A 18MMX40CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS STUCK IN THE MIDDLE PART OF A NON-BOSTON SCIENTIFIC MICROCATHETER AND COULD NOT BE PUSHED OUT OF THE DELIVERY SYSTEM. THE COIL COULD NOT BE PULLED BACK SO IT WAS WITHDRAWN TOGETHER WITH THE CATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE. HOWEVER, DEVICE INVESTIGATION REVEALED THAT THE INTERLOCKING ARM OF THE MAIN COIL AND DELIVERY WIRE WERE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15254457 ↗
• MalfunctionJan 7, 2022Stretched; Separation Failure; Physical Resistance/Sticking; Stretched; Separation Failure; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15DEC2021. IT WAS REPORTED THAT THE DEVICE STRETCHED AND FAILED TO DEPLOY. THE TARGET LESION WAS LOCATED IN THE ESOPHAGOGASTRIC FUNDUS VEIN. A 18MMX40CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT RESISTANCE WAS ENCOUNTERED UPON REPEATEDLY DELIVERING THE DEVICE, AND SO THE DEVICE WAS SIMPLY PULLED OUT. HOWEVER, IT WAS FOUND THAT THE COIL WAS UNWOUND AND FAILED TO DEPLOY AND GOT STRETCHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT IS STABLE. HOWEVER, DEVICE INVESTIGATIONS REVEALED LOSS OF FIBERS AND THE INTERLOCKING ARM DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13196829 ↗
• MalfunctionSep 16, 2021Separation Failure; Separation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 25AUG2021. IT WAS REPORTED THAT THE COIL FAILED TO DEPLOY. AN 18MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT COIL FAILED TO DEPLOY. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED INTERLOCKING ARM DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12481336 ↗
• MalfunctionFeb 26, 2021Entrapment of Device; Physical Resistance/Sticking; Entrapment of Device; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 11FEB2021. IT WAS REPORTED THAT THE COIL COULD NOT ADVANCE THROUGH THE MICROCATHETER. A 2D 18MM X 40CM INTERLOCK-35 EMBOLICS WAS SELECTED FOR USE IN AN EMBOLIZATION OF THE SPLEENIC ARTERY. DURING THE PROCEDURE, RESISTANCE WAS FELT UPON ADVANCEMENT ON THE COIL. SUBSEQUENTLY, IT WAS NOTED THAT THE DEVICE COULD NOT BE PUSHED AND WAS STUCK AT THE MIDDLE OF THE CATHETER. THE DEVICE WAS PULLED OUT, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO COMPLICATIONS REPORTED AND THE PATIENT WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED A DETACHED INTERLOCKING ARM AND LOSS OF PROXIMAL FIBER BUNDLES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11385715 ↗
• MalfunctionJan 21, 2021Separation Failure; Separation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 08 JAN 2021. IT WAS REPORTED THAT THE COIL COULD NOT DETACHED. THE TARGET LESION WAS LOCATED IN THE PULMONARY ARTERY. AN 18MM X 40CM INTERLOCK -35 WAS SELECTED FOR USE. DURING PROCEDURE, THE GUIDEWIRE WAS ADVANCE AND CATHETER WAS ENGAGED, HYDRATED CONTINUOUSLY AND CONNECTED TO THE CATHETER HUB SMOOTHLY. HOWEVER, THE COIL COULD NOT DETACH WHEN DEPLOYED. THE DEVICE WAS REMOVED FROM THE CATHETER. THEN, ANOTHER 15MM X 40MM INTERLOCK WAS ADVANCED DISTALLY THROUGH THE SAME CATHETER AND NOTICED TO LODGED INSIDE BEFORE COMING OUT FROM THE CATHETER TIP. THE COIL WAS FOUND INSIDE THE CATHETER. THE COIL WAS RETRIEVED SLOWLY BY PULLING IT INTO THE LONG SHEATH ASSISTED BY A SNARE WHILE INSIDE THE CATHETER. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO COMPLICATIONS REPORTED AND PATIENT WAS STABLE. HOWEVER, DEVICE ANALYSIS REVEALED MISSING FIBER BUNDLES AND DETACHED INTERLOCK ARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11208466 ↗
• MalfunctionNov 3, 2020Stretched; Physical Resistance/Sticking; Stretched; Physical Resistance/Sticking

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 22OCT2020. IT WAS REPORTED THAT COIL FRICTION OCCURRED AND THE COIL WAS STRETCHED. THE TARGET AREA WAS LOCATED IN THE GASTRIC VEIN. A 18MM X 40CM INTERLOCK -35 COIL WAS SELECTED FOR USE. DURING PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE PUSHED CONTINUOUSLY WHEN REACHED HALF OF THE CATHETER. IT WAS ALSO FOUND OUT THAT THE COIL WAS STRETCHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT WAS STABLE POST PROCEDURE. PATIENT WAS STABLE POST PROCEDURE. HOWEVER, DEVICE ANALYSIS REVEALED THAT THERE WAS MISSING FIBER BUNDLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10779804 ↗
• MalfunctionOct 20, 2020Entrapment of Device; Separation Failure; Entrapment of Device; Separation Failure

  IT WAS REPORTED THAT THE COIL PROTRUDED IN THE CATHETER'S TIP DURING REMOVAL. A 18MMX40CM INTERLOCK-35 COIL WAS SELECTED FOR USE ON THE ABDOMINAL AORTA. DURING THE PROCEDURE, AFTER THE COATED STENT WAS USED, LEAKAGE WAS FOUND AND IT WAS EMBOLIZED WITH A COIL. THEN, THIS COIL WAS DEPLOYED 2CM AND WAS FOUND TO BE IN A BAD POSITION, SO IT WAS RETRIEVED INTO THE CATHETER AND RE-DEPLOYED. HOWEVER, IT WAS NOTED THAT THE COIL WAS STUCK AND COULD NOT BE DEPLOYED INSIDE THE CATHETER DISTAL PART, AND PROTRUDED IN THE CATHETER'S TIP DURING REMOVAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10706001 ↗