Interlock™-35 M001363820Recalls & reported problems

Summary

The FDA's MAUDE database contains 65 adverse event reports that list this exact device (DI 08714729795438), received between Aug 28, 2018 and May 18, 2026 — classified as 1 death, 3 injuries, 61 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (29 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 65 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 18, 2026Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON (B)(6) 2026. IT WAS REPORTED THAT THE MAIN COIL COULD NOT BE PUSHED. THE PATIENT PRESENTED WITH BILATERAL ILIAC ANEURYSMS, INCLUDING INVOLVEMENT OF THE INTERNAL ILIAC ARTERY. A 15MM X 40CM INTERLOCK 35 WAS SELECTED FOR EMBOLIZATION. ACCESS WAS OBTAINED VIA THE LEFT PUNCTURE SITE, AND A GUIDEWIRE WAS ADVANCED INTO THE RIGHT INTERNAL ILIAC ARTERY. FOLLOWING GUIDEWIRE PLACEMENT, ANGIOGRAPHY WAS PERFORMED USING A CORDIS 5F ANGIOGRAPHY CATHETER POSITIONED AT THE TARGET EMBOLIZATION SITE. THE 15MM X 40CM INTERLOCK-35 COIL WAS ADVANCED; HOWEVER, THE COIL COULD NOT BE PUSHED OUT OF THE CATHETER FOR DEPLOYMENT. MULTIPLE ATTEMPTS WERE MADE BY THE PHYSICIAN TO DEPLOY THE COIL, BUT THESE ATTEMPTS WERE UNSUCCESSFUL. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER 15MM X 40CM INTERLOCK-35 COIL OF THE SAME SPECIFICATION, WHICH WAS SUCCESSFULLY USED TO COMPLETE THE EMBOLIZATION. THE PATIENT REMAINED STABLE FOLLOWING THE PROCEDURE 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 25205160 ↗
• MalfunctionApr 2, 2026Failure to Advance; Difficult to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 09MAR2026. IT WAS REPORTED THAT COIL WAS UNABLE TO ADVANCE IN THE MICROCATHETER. THE TARGET LESION WAS LOCATED IN THE SPLENIC ARTERY. A 15MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, THE COIL COULD NOT BE PUSHED OUT OF THE CATHETER, AND COULD THEREFORE NOT BE DEPLOYED. WHEN IT WAS PUSHED TO THE MIDDLE OF THE CATHETER, OBVIOUS RESISTANCE WAS FELT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED THE ARM COIL AND ZAP TIP HAD DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767748 ↗
• MalfunctionMar 17, 2026Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 18FEB2026. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED FROM THE CATHETER. A 15MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR USE IN THE ABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE, UPON ADVANCING THE SPRING COIL INTO THE MIDDLE OF THE CATHETER, THE SPRING COIL COULD NOT BE PUSHED OUT. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24618237 ↗
• MalfunctionFeb 26, 2026Nonstandard Device; Difficult to Remove; Stretched; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30JAN2026. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED AND WITHDRAWN FROM THE CATHETER. THE PATIENT PRESENTED WITH LIVER CIRRHOSIS AND UPPER GASTROINTESTINAL BLEEDING. A 15MM X 40CM INTERLOCK?-35 WAS SELECTED FOR USE IN A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) AND VARICEAL EMBOLIZATION. DURING THE PROCEDURE, A Y-VALVE WAS CONNECTED, AND CONTINUOUS FLUSHING WITH HEPARINIZED NORMAL SALINE WAS PERFORMED. UPON INSERTING THE COIL INTO THE NON-BSC CATHETER, THE COIL WAS STUCK IN THE CATHETER AND COULD NOT BE REMOVED. AFTER REPEATED ATTEMPTS, IT STILL COULD NOT BE WITHDRAWN. THE COIL WAS REMOVED TOGETHER WITH THE CATHETER FROM THE BODY, AND THE COIL WAS FOUND STRETCHED. 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 ARM WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24457823 ↗
• MalfunctionDec 19, 2025Entrapment of Device; Difficult to Remove; Stretched; Failure to Advance; Adverse Event Without Identified Device or Use Problem; Entrapment of Device; Difficult to Remove; Stretched; Failure to Advance; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COIL PROTRUDED FROM THE CATHETER'S TIP. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 15MM X 40CM INTERLOCK .035 COIL WAS SELECTED FOR TRANSCATHETER INTERNAL ILIAC ARTERY EMBOLIZATION. HOWEVER, AFTER THE COIL WAS PUSHED OUT OF THE CATHETER FOR ABOUT 5 CM, IT WAS NOTED THAT THE PART WITHIN THE CATHETER COULD NOT BE PUSHED OUT OR PULLED BACK. THE PHYSICIAN COULD ONLY WITHDRAW THE COIL AND THE PROTECTIVE SHEATH TOGETHER FROM THE PATIENT'S BODY. ATTEMPTING TO PUSH OR PULL THE COIL OUTSIDE THE PATIENT'S BODY ALSO RESULTED IN THE SAME OUTCOME. AFTER TAKING OUT THE COIL, IT WAS FOUND THAT THE COIL WAS STRETCHED. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23854873 ↗
• MalfunctionNov 19, 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 22OCT2025. IT WAS REPORTED THAT THE COIL COULD NOT BE ADVANCED FROM THE CATHETER. A 15MM X 40CM INTERLOCK .035 WAS SELECTED FOR EMBOLIZATION OF ANEURYSM. DURING THE PROCEDURE, THE COIL COULD NOT BE PUSHED OUT OF THE NON-BOSTON SCIENTIFIC 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 INTERLOCKING ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23597728 ↗
• MalfunctionOct 23, 2025Separation Failure; Adverse Event Without Identified Device or Use Problem; Separation Failure; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26SEP2025. IT WAS REPORTED THAT DEVICE FAILURE TO SEPARATE OCCURRED. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTA. A 15MM X 40CM INTERLOCK .035 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE DEPLOYED IN THE DELIVERY SYSTEM, AND THE CONTROLLABLE COIL WAS WITHDRAWN OUTSIDE THE BODY. 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 ARM COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23371163 ↗
• MalfunctionSep 15, 2025Break; Adverse Event Without Identified Device or Use Problem; Break; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT COIL DETACHMENT OCCURRED. A 15MM X 40CM .035 INTERLOCK WAS SELECTED FOR USE IN A TRANSCATHETER RETROGRADE SPLENORENAL SHUNT VEIN EMBOLIZATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL WAS DETACHED AND COULD NOT BE USED NORMALLY. THE PROCEDURE WAS COMPLETED WITH A NEW DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23058290 ↗
• MalfunctionJul 28, 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 01JUL2025. IT WAS REPORTED THAT THE COIL PREMATURE DEPLOYMENT OCCURRED. THE PATIENT UNDERGONE AN ENDOVASCULAR PROCEDURE INVOLVING THORACIC AORTIC STENT GRAFTING WITH SUBCLAVIAN AND COMMON CAROTID ARTERY RECONSTRUCTION USING THE CHIMNEY TECHNIQUE. HOWEVER, A SMALL ENDOLEAK WAS NOTED AT THE SUBCLAVIAN ARTERY ORIGIN AFTER STENT DEPLOYMENT. A 15MM X 40CM INTERLOCK .035 WAS SELECTED FOR USE IN AN EMBOLIZATION. HOWEVER, UPON OPENING THE PACKAGING, IT WAS NOTED THAT THE COIL WAS PREMATURELY DEPLOYED. 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 WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22630102 ↗
• MalfunctionJul 24, 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 26JUN2025. IT WAS REPORTED THAT COIL UNABLE TO ADVANCE OCCURRED. THE TARGET LESION WAS LOCATED IN THE SEVERE TORTUOUS AND NON CALCIFIED SPLENIC ARTERY. A 15MM X 40CM .035 INTERLOCK CUBE WAS USED FOR PROCEDURE. PRIOR TO THE PROCEDURE, IT WAS CONFIRMED THAT THE PRODUCT INTERLOCKING ARM WAS SECURELY LOCKED. HOWEVER, THE COIL COULD NOT BE ADVANCED OUT OF THE CATHETER, WHICH CAUSED IT TO BECOME UNHOOKED INSIDE THE CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED USING ANOTHER DEVICE OF THE SAME TYPE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED A DETACHED AT THE COIL ARM SECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22589012 ↗
• MalfunctionMay 23, 2025Separation Failure; Adverse Event Without Identified Device or Use Problem; Separation Failure; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 30APR2025. THE TARGET LESION WAS LOCATED IN THE ABDOMINAL AORTA. A 15MM X 40CM INTERLOCK-35 WAS SELECTED FOR ABDOMINAL AORTA COATED STENT ENDOVASCULAR ISOLATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE RELEASED AFTER REACHING THE LESION POSITION. THE DEVICE 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 THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22077640 ↗
• MalfunctionMar 25, 2025Stretched; Separation Failure; Material Integrity Problem; Stretched; Separation Failure; Material Integrity Problem

  IT WAS REPORTED THAT THE DEVICE WAS SEPARATED. A 15MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE DURING AN EMBOLIZATION PROCEDURE. DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY THE COILS, IT WAS NOTED THAT A SEPARATION OCCURRED. THE COIL WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT DURING DEPLOYMENT, THE COIL REMAINED ATTACHED TO ITS PUSHER AND DID NOT DETACH. UPON ATTEMPTING TO REMOVE THE DEVICE, THE COIL BEGAN TO UNRAVEL, CAUSING IT TO ELONGATE. IT WAS NOTED THAT THE COIL HAD UNRAVELED TO THE POINT THAT WHEN THE MAIN DEVICE WAS REMOVED, THEY HAD TO CONTINUE PULLING OUT THE UNRAVELED PORTION UNTIL IT WAS ALL OUT OF THE BODY. THERE WAS NOT A SEPARATE SECTION THAT HAD TO BE REMOVED SEPARATELY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21691723 ↗
• MalfunctionMar 13, 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 16FEB2025. IT WAS REPORTED THAT THE COIL COULD NOT BE PUSHED OUT AND WAS UNHOOKED IN THE CATHETER. THE TARGET LESION WAS LOCATED IN THE PELVIC ARTERY AND VEIN. A 15MM X 40CM INTERLOCK-35 COIL WAS SELECTED FOR EMBOLIZATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE PUSHED OUT WHEN IT WAS PUSHED TO THE ORIFICE IN THE ANGIOGRAPHY CATHETER EVEN AFTER MANY ATTEMPTS. IT WAS THEN NOTED THAT THE SPRING COIL HAD BEEN UNHOOKED IN THE CATHETER. HEPARIN SALINE WAS THEN DRIPPED CONTINUOUSLY, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THE MAIN COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21599003 ↗
• MalfunctionFeb 10, 2025Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 15JAN2025. IT WAS REPORTED THAT THE COIL COULD NOT ADVANCE. A 15MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE IN AN ABDOMINAL AORTIC ANEURYSM AND ILIAC ANEURYSM. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT CONTINUE TO ADVANCE NORMALLY. 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 INTRODUCER SHEATH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21347227 ↗
• MalfunctionDec 31, 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 12DEC2024. IT WAS REPORTED THAT THE COIL BECAME STUCK WHEN PUSHED. A 15MM X 40CM INTERLOCK-35 COIL WAS SELECTED FOR EMBOLIZATION. DURING THE PROCEDURE, THE CATHETER WAS PLACED FIRST, AND THEN THE 5F ANGIOGRAPHY CATHETER WAS USED AND REACH THE POSITION. THE INTERLOCK-18 AND 35 COILS WERE PREPARED IN A STERILE WAY AND OPERATED SMOOTHLY. WHEN THIS DEVICE WAS USED, IT BECAME STUCK WHEN PUSHED TO THE END. THIS COIL COULD NOT BE PUSHED OUT SMOOTHLY EVEN IF IT WAS PULLED BACK. THE DEVICE WAS REMOVED TOGETHER WITH THE MICROCATHETER. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS WERE REPORTED, AND THE 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 21048724 ↗
• MalfunctionNov 27, 2024Break; Premature Activation; Stretched; Adverse Event Without Identified Device or Use Problem; Break; Premature Activation; Stretched; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A COIL BREAK OCCURRED. THE TARGET LESION WAS LOCATED IN A NON-TORTUOUS ILIACA INTERNA. A .035 INTERLOCK CUBE 15MM X 40CM WAS SELECTED TO TREAT AN ILIACA INTERNA ANEURYSM. DURING THE PROCEDURE, THE COIL WAS PUSHED ABOUT HALFWAY OUT OF THE DIAGNOSTIC CATHETER, THEN AN ATTEMPT WAS MADE TO PULL THE COIL BACK AGAIN TO REPOSITION THE CATHETER. THE COIL GOT STUCK IN THE CATHETER AS IT WAS ALREADY PARTIALLY THROMBOGENIZED. THE PHYSICIAN THEN PULLED A LITTLE TOO TIGHTLY, CAUSING THE COIL TO STRETCH AND THE DETACHMENT ARM TO DETACH FROM THE COIL. THE DIAGNOSTIC CATHETER WITH COMPLETE COIL WAS REMOVED FROM THE PATIENT. A NEW CATHETER AND COIL WERE SUCCESSFULLY USED. NO PATIENT HARM OCCURRED. IT WAS FURTHER REPORTED THAT THERE WAS NO BREAK OBSERVED, RATHER THE INTERLOCKING ARMS UNLOCKED INSIDE OF THE DIAGNOSTIC CATHETER. THE PUSHER WIRE OF THE INTERLOCK WAS PULLED COMPLETELY OUT OF THE CATHETER WHILE THE COIL REMAINED IN THE CATHETER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20790347 ↗
• MalfunctionOct 31, 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 THE DEVICE ANALYSIS COMPLETED ON 03OCT2024. IT WAS REPORTED THAT A COIL ADVANCEMENT ISSUE OCCURRED. A 15 MM X 40 CM INTERLOCK-35 WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE INTERLOCKING ARM OF THE COIL HAD DETACHED AND COULD NOT BE PUSHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WAS NO PATIENT COMPLICATIONS REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THE INTERLOCKING ARM HAD BROKEN OFF THE MAIN COIL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20578210 ↗
• MalfunctionOct 23, 2024Failure to Advance; Separation Failure; Failure to Advance; Separation Failure

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26SEP2024. IT WAS REPORTED THAT A COIL ADVANCING, AND DEPLOYMENT ISSUE OCCURRED. A 15MM X 40CM INTERLOCK-35 COIL WAS SELECTED FOR SPLENIC ANEURYSM IMPLANTATION. HOWEVER, DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL COULD NOT BE DETACHED AND PUSHED OUT IN THE CATHETER. THE DEVICE WAS REMOVED AND 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 THE ZAP TIP, AND THE ARM COIL WERE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20516261 ↗
• MalfunctionOct 22, 2024Failure to Advance; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 26SEP2024. IT WAS REPORTED THAT THE COIL WAS UNABLE TO ADVANCE IN THE CATHETER. THE PATIENT PRESENTED WITH ABDOMINAL AORTIC ANEURYSM LARGER THAN 5CM, AND THE TUMOR WAS ACCUMULATED IN THE COMMON ILIAC ARTERY. A 15MM X 40CM INTERLOCK-35 COIL WAS SELECTED FOR PERCUTANEOUS ARTERIAL EMBOLIZATION. DURING THE PROCEDURE, THE COIL WAS PLACED IN THE LUMEN OF THE INTERNAL ILIAC ARTERY. HOWEVER, IT WAS NOTED THAT THE COIL COULD NOT BE PUSHED INTO THE TAIL END OF THE ANGIOGRAPHY CATHETER BUT COULD BE WITHDRAWN. THE COIL WAS DEPLOYED AGAIN AFTER IT WAS FLUSHED WITH HEPARIN SALINE, BUT IT STILL COULD NOT BE PUSHED. THE COIL WAS REMOVED, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER COIL OF THE SAME MODEL. NO COMPLICATIONS WERE REPORTED, AND THE 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 20509816 ↗
• MalfunctionAug 1, 2024Break; Failure to Advance; Break; Failure to Advance

  IT WAS REPORTED THAT A DEVICE FRACTURE OCCURRED. TWO 15MM X 40CM INTERLOCK-35 COILS WERE SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE LOCATED IN THE ABDOMINAL AORTIC ANEURYSM AND THE INTERNAL ILIAC ARTERY. DURING THE PROCEDURE, WHEN PLACING THE FIRST COIL, IT WAS FOUND THAT THE COIL COULD NOT BE PUSHED OUT OF THE DELIVERY CATHETER, AND TWO POSITIONS OF THE INTERLOCKING ARM WERE FRACTURED. THIS COIL WAS REMOVED, AND EXCHANGED FOR A NEW COIL, SAME MODEL. THE SECOND COIL WAS ADVANCED. HALF OF IT WAS RELEASED INTO THE ANEURYSM CAVITY. HOWEVER, THE POSITION WAS NOT PROPER, SO IT WAS WITHDRAWN. WHEN THE TIP OF THE COIL WAS WITHDRAWN NEARLY TO THE ANGIOGRAPHY CATHETER, IT COULD NOT BE WITHDRAWN, AND THE INTERLOCKING ARM CONNECTION WAS FOUND TO BE FRACTURED. THE COIL WAS REMOVED ALONG WITH THE ANGIOGRAPHY CATHETER, AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19883759 ↗
• MalfunctionJul 3, 2024Separation Failure; Adverse Event Without Identified Device or Use Problem; Separation Failure; Adverse Event Without Identified Device or Use Problem

  REPORTABLE BASED ON DEVICE ANALYSIS. IT WAS REPORTED THAT THE COIL FAILED TO SEPARATE. A 15MM X 40CM .035 INTERLOCK CUBE WAS SELECTED FOR THE PROCEDURE. AT THE TIME OF RELEASE, HOWEVER, THE COIL WOULD NOT SEPARATE FROM THE CATHETER. THE COIL WAS REMOVED WITH THE CATHETER. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED. HOWEVER, DEVICE ANALYSIS REVEALED THE COIL ARM HAD DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19665677 ↗
• MalfunctionJun 13, 2024Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24MAY2024. IT WAS REPORTED THAT COIL WAS STUCK INSIDE THE CATHETER. THE TARGET LESION WAS LOCATED IN THE INTERNAL ILIAC ARTERY. A 15MM X 40CM INTERLOCK-35 WAS SELECTED FOR USE. DURING THE PROCEDURE, IT WAS NOTED THAT THE COIL GOT STUCK INSIDE THE IMAGING CATHETER, IT COULD NEITHER BE WITHDRAWN NOR BE DELIVERED. EVENTUALLY IT WAS REMOVED ALONG WITH THE DELIVERY SYSTEM AND 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 ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19531667 ↗
• MalfunctionMay 29, 2024Break; Positioning Problem; Break; Positioning Problem

  IT WAS REPORTED THAT A COIL BREAK OCCURRED. A 15MM X 40CM INTERLOCK-35 WAS SELECTED FOR INTERNAL ILIAC EMBOLIZATION. DURING THE PROCEDURE, IT WAS NOTED THAT THE CONTRAST CATHETER BOUNCED BACK. SUBSEQUENTLY, DURING THE PROCESS OF WITHDRAWING, THE COIL WAS FRACTURED. 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 19419486 ↗
• MalfunctionMay 20, 2024Difficult to Remove; Adverse Event Without Identified Device or Use Problem; Difficult to Remove; 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 BE WITHDRAWN FROM THE CATHETER. A 15MM X 40CM INTERLOCK-35 WAS SELECTED FOR ABDOMINAL AORTIC ANEURYSM PROCEDURE. DURING THE EMBOLIZATION OF THE INTERNAL ILIAC ARTERY, THE 5F NON-BSC CATHETER WAS USED. HOWEVER, WHEN THE COIL WAS DEPLOYED, IT WAS NOTED THE POSITION WAS NOT GOOD DUE TO SEVERE TORTUOSITY, AND IT COULD NOT BE WITHDRAWN. THE COIL WAS REMOVED TOGETHER WITH THE CATHETER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO COMPLICATIONS 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 19352962 ↗
• MalfunctionMay 13, 2024Premature Activation; Failure to Advance; Premature Activation; Failure to Advance

  REPORTABLE BASED ON DEVICE ANALYSIS COMPLETED ON 24-APR-2024. IT WAS REPORTED THAT THE FAILURE TO ADVANCE IN CATHETER AND PREMATURE DEPLOYMENT OCCURRED. THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM, AND EMBOLIZATION WAS SCHEDULED FOR INTERNAL ILIAC ARTERY WITH MEDIUM TORTUOSITY. AN IMAGING CATHETER WAS USED FOR DEPLOYMENT, BUT AFTER CROSSING THE CENTRAL LINE, THE COIL COULD NOT BE ADVANCED THROUGH THE CATHETER. THE COIL COULD NOT BE DELIVERED DESPITE MULTIPLE ATTEMPTS, AND UPON CHECKING, IT WAS NOTED THAT THE INTERLOCK ARMS HAD ALREADY RELEASED. THE DEVICE WAS REMOVED TOGETHER WITH THE CATHETER AND THE PROCEDURE WAS COMPLETED WITH ANOTHER OF SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED, AND THE PATIENT STATUS WAS STABLE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED THAT THE ARM COIL WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19299048 ↗