BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DELTAPLUSH - CERECYTE MICROCOIL

    MDR report key: 5806738 · Received July 19, 2016

    Report

    Report Number
    2954740-2016-00159
    Event Type
    Malfunction
    Date Received
    July 19, 2016
    Date of Event
    June 24, 2016
    Report Date
    June 28, 2016
    Manufacturer
    MEDOS INTERNATIONAL SARL
    Product Code
    HCG
    PMA / PMN Number
    K083646
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF ONE INITIAL/FINAL MDR REPORT BEING SUBMITTED FOR THIS COMPLAINT. (B)(4). CONCOMITANT MEDICAL PRODUCTS: EXCELSIOR SL-10 (STRYKER) MICROCATHETER, Y-CONNECTOR BY TERUMO (MODEL UNKNOWN), ENPOWER DCB / CABLE (LOTS UNKNOWN), TARGET COIL. VERY LIMITED INFORMATION WAS RECEIVED. THE DEVICE POSITIONING UNIT (DPU) (G14608) WAS NOT RETURNED. AS VIEWED THROUGH THE RETURNED PACKAGING, IT WAS FOUND THAT ONLY A DETACHED COIL WAS RETURNED ALONG WITH THE SL-10 MICROCATHETER AS THE DPU WAS NOT RETURNED. PAST THE PROXIMAL DAMAGED SECTION, THE REMAINDER OF THE COIL IS UNDAMAGED. THE COIL¿S SOCKET RING HAS BEEN BENT DISTALLY APPROXIMATELY 90 DEGREES. THE PROXIMAL SECTION OF THE COIL HAS SEVERED COMPRESSION AND BUCKLING DAMAGE. THE SL-10 MICROCATHETER¿S INNER LUMEN AND THE OUTER DIAMETER AT THE COMPLAINT AREA ARE UNDAMAGED AS IS THE REMAINDER OF THE MICROCATHETER. A TEST COIL AND GUIDE WIRE WERE BOTH SUCCESSFULLY ADVANCED THROUGH AND OUT THE DISTAL TIP OF THE MICROCATHETER MULTIPLE TIMES WITH NO PROBLEMS ENCOUNTERED. THE MICROCATHETER DID NOT CONTRIBUTE TO THE FIELD COMPLAINT. THE COMPLAINT OF THE COIL BEING STUCK AT THE DISTAL TIP OF THE MICROCATHETER IS NOT CONFIRMED. DUE TO THE COIL BEING REMOVED FROM THE MICROCATHETER WHICH WAS NOT REPORTED WHICH MAY HAVE PRODUCED FURTHER DAMAGE AND DUE TO THE FACT THAT THE PROXIMAL END OF THE COMPLAINT COIL ALSO HAD A COMPETITOR¿S COIL ADVANCED INTO IT, ADDITIONAL DAMAGES MAY HAVE OCCURRED UNRELATED TO THE COMPLAINT EVENT. DUE TO THE FACT THAT THE DPU WAS NOT RETURNED AND THAT THE COIL THAT SHOULD HAVE BEEN DETACHED INSIDE THE TARGET SITE WHICH WAS NOT FLURO CONFIRMED, THE ROOT CAUSE OF THE COIL BEING STUCK OR DETACHED INSIDE THE MICROCATHETER CANNOT BE DETERMINED, FURTHERMORE NO CONTRIBUTING FACTOR CAN BE ASSIGNED TO THIS COMPLAINT, HOWEVER THE COILS PLACEMENT INSIDE THE TARGET SITE AND ITS DETACHMENT WERE NOT REPORTED TO HAVE BEEN FLUOROSCOPICALLY VERIFIED. FOR OPTIMUM PRODUCT PERFORMANCE AND TO PREVENT POTENTIAL COMPLICATIONS, THE INSTRUCTIONS FOR USE (IFU) RECOMMENDS, ¿¿RE VERIFY THE POSITION OF THE MICROCOIL WITHIN THE ANEURYSM VIA FLUOROSCOPY. THE CODMAN MICROCOIL SYSTEM IS NOW READY FOR DETACHMENT. AFTER THE LIGHT GOES OUT AND THE TONE STOPS, DETACHMENT OF THE MICROCOIL FROM THE DPU WIRE MUST BE FLUOROSCOPICALLY VERIFIED BY GENTLY WITHDRAWING THE DPU WIRE BACK APPROXIMATELY ONE (1) MM. OBSERVE IF THE MICROCOIL HAS DETACHED¿¿ IN ADDITION, WITHOUT THE RETURN OF THE DPU USED IN THE PROCEDURE WITH THE COMPLAINT COIL, IT CANNOT BE DETERMINED IF THIS COMPONENT HAD ANY ADDITIONAL CONTRIBUTIONS TO THE COMPLAINT EVENT. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING OR INSPECTION PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. THE COMPLAINT OF THE COIL BEING STUCK AT THE DISTAL TIP OF THE SL-10 MICROCATHETER IS NOT CONFIRMED. THE COIL WAS REMOVED FROM THE MICROCATHETER WHICH WAS NOT REPORTED, REMOVING THE COIL MAY HAVE PRODUCED FURTHER DAMAGE AND DUE TO THE FACT THAT THE PROXIMAL END OF THE COMPLAINT COIL ALSO HAD A COMPETITOR¿S COIL ADVANCED INTO IT, ADDITIONAL DAMAGES MAY HAVE OCCURRED UNRELATED TO THE COMPLAINT EVENT. NO CONTRIBUTING FACTORS CAN BE ASSIGNED TO THIS COMPLAINT. SINCE THERE WAS NO EVIDENCE OF A MANUFACTURING ISSUE RELATED TO THE EVENT, NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY A HEALTH CARE PROFESSIONAL, DURING THE PROCEDURE IT WAS FOUND THAT THE MICROCOIL OF DELTAPLUSH (CPL10020630/G14608) WAS STUCK AT THE MICROCATHETER TIP (COMPETITOR'S MC). IT WAS REPORTED THAT THE COMPLAINT DELTAPLUSH WAS DELIVERED AND DETACHED INTO THE TARGET VESSEL WITHOUT A PROBLEM, THE NEXT COIL (COMPETITOR'S COIL) INSERTED GOT STUCK AT THE DISTAL END OF THE MICROCATHETER AND COULD NOT BE PUSHED OUT FROM IT. THE TARGET VESSEL WAS NOT YET FULLY AND TIGHTLY PACKED WITH THE COILS AT THIS POINT. THE PHYSICIAN CHECKED THE DISTAL TIP AND FOUND THAT THE COIL WAS NOT ACTUALLY STUCK BUT THE MICROCOIL OF THE COMPLAINT DELTAPLUSH WAS STUCK AT THE MICROCATHETER TIP. THE PHYSICIAN TRIED TO PUSH THE DELTAPLUSH COIL OUT WITH THE TARGET COIL AND THE GUIDE WIRE; HOWEVER THE DELTAPLUSH COIL WAS STUCK AND COULD NOT BE PUSHED OUT. THE PHYSICIAN EVENTUALLY REMOVED THE MICROCATHETER STUCK WITH THE MICROCOIL, AND A NEW MICROCATHETER WAS INSERTED INSTEAD. THE SURGERY WAS COMPLETED WITHOUT FURTHER ISSUES, BUT DUE TO THE EVENT THERE WAS 10 MINUTES SURGICAL DELAY. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. THE PROCEDURE WAS THE TRANSVENOUS EMBOLIZATION OF A DURAL ARTERIOVENOUS FISTULA AT THE TS. THE PATIENT WAS A MALE OF UNKNOWN DOB, WHOSE VESSELS WERE MILDLY TORTUROUS BUT NOT CALCIFIED. THE COMPLAINT PRODUCT WAS NEW AND STORED PER LABELING INSTRUCTION. THE PROCEDURE WAS CONDUCTED IN ACCORDANCE WITH THE IFU AND THE CONSTANT FLUSH HAD BEEN MAINTAINED AT ALL TIMES. NO VISIBLE DAMAGES WERE NOTED ON THE COMPLAINT COIL PRIOR TO THE EVENT. THE REPORTER PROVIDED PICTURE OF THE MICROCOIL POST PROCEDURE; HOWEVER UNKNOWN IF MICROCOIL IS DAMAGED. THERE WERE NO DAMAGES NOTED ON THE CONCOMITANT DEVICES PRIOR TO OR AFTER THE EVENT. IT WAS REPORTED THAT THE COMPLAINT PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE SL-10 MICROCATHETER IS NOT AVAILABLE FOR RETURN. NO FURTHER INFORMATION IS CURRENTLY AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457324 DELTAPLUSH - CERECYTE MICROCOIL DEVICE, NEUROVASCULAR EMBOLIZATION HCG MEDOS INTERNATIONAL SARL G14608

    Patients

    Seq Age Sex Outcome Treatment
    1