BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 1242598 · Received November 24, 2008

    Report

    Report Number
    3004742232-2008-00014
    Event Type
    Injury
    Date Received
    November 24, 2008
    Date of Event
    October 29, 2008
    Report Date
    October 30, 2008
    Manufacturer
    CARDIOVASCULAR SYSTEMS, INC.
    Product Code
    MCW
    PMA / PMN Number
    K071427
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION - THE FACILITY HAS RETAINED THE DEVICE, THEREFORE, NO DIRECT DEVICE ANALYSIS IS POSSIBLE. THE DEVICE HISTORY RECORD FOR THIS LOT NUMBER HAS BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE DEVICE MET ITS MATERIAL, ASSEMBLY, AND QUALITY CONTROL REQUIREMENTS. IN DISCUSSING THE EVENT WITH THE DSM, THE PHYSICIAN CONCURRED THAT HIS SCRUB PERSON HAD ALLOWED THE WIRE TO GO FURTHER DOWN THE VESSEL THAN RECOMMENDED, AND THAT PLAYED A ROLE IN THE WIRE TIP GETTING STUCK WHERE IT DID.

    Description of Event or Problem · 1

    RELATED TO MEDICAL DEVICE MANUFACTURER'S REPORT# 3004742232-2008-00013. IT WAS REPORTED THAT DURING AN ORBITAL ATHERECTOMY TREATMENT PROCEDURE, THE RADIOPAQUE TIP OF THE GUIDE WIRE FRACTURED AND REMAINS IN THE PATIENT'S BODY. THE PERONEAL ARTERY LESION WAS HEAVILY CALCIFIED AND 10 CM IN LENGTH; HALF OF THE LESION DEMONSTRATED 100% OCCLUSION WHILE THE OTHER HALF WAS 60-90% STENOTIC. THE PHYSICIAN ACCESSED THE LESION USING A 7F INTRODUCER SHEATH VIA AN UP-AND-OVER, CONTRALATERAL APPROACH AND A VIPERWIRE FLEX WAS DELIVERED ACROSS THE LESION. A 1.25 MM SOLID CROWN DIAMONDBACK OAD WAS INTRODUCED AND SPUN FOR ONE MINUTE AT 80K RMPS, THEN FOR ONE MINUTE AT 140K RPMS WITHOUT CROSSING THE LESION. A VIPERWIRE FIRM WAS THEN DELIVERED ACROSS LESION AND A 1.5MM SOLID CROWN DIAMONDBACK OAD WAS SPUN FOR ONE MINUTE ON MEDIUM SPEED AND SUCCESSFULLY CROSSED THE PROXIMAL PORTION OF THE LESION, BUT THEN BECAME WEDGED IN THE LESION AND STOPPED SPINNING. DURING THE ATTEMPT TO PULL BACK AND REMOVE THE OAD, THE GUIDE WIRE AND DRIVE SHAFT OF THE DIAMONDBACK OAD BROKE. THE DRIVE SHAFT AND CROWN WERE SUCCESSFULLY REMOVED FROM SHEATH, BUT THE DISTAL RADIOPAQUE SEGMENT OF THE VIPERWIRE REMAINED IN THE SMALL, DISTAL, SIDE BRANCH OF THE PERONEAL ARTERY. THE PHYSICIAN ELECTED TO COMPLETE THE PLANNED INTERVENTION AND THEN SNARE THE WIRE FRAGMENT. ANOTHER VIPERWIRE FIRM WAS INTRODUCED ACROSS THE LESION AND ANOTHER 1.5MM SOLID CROWN DIAMONDBACK OAD WAS SPUN AT 200K RPMS FOR FOUR RUNS OF ONE MINUTE EACH. THE ANGIOGRAPHIC RESULT WAS EXCELLENT, SO THE PHYSICIAN ATTEMPTED TO SNARE THE INITIALLY FRAGMENTED WIRE, BUT THE SNARE WAS NOT LONG ENOUGH TO REACH THE LEFT ANKLE FROM THE RIGHT GROIN. THE PHYSICIAN INSERTED A 5F SHEATH VIA AN ANTEGRADE APPROACH INTO THE LEFT GROIN AND INTRODUCED A GOOSENECK SNARE, BUT WAS UNABLE TO REACH THE WIRE FRAGMENT DUE TO DIFFUSE DISEAE IN THE DISTAL PERONEAL ARTERY. THIS AREA WAS DILATED WITH 1.5MM, 2.0MM, AND 2.5MM PTCA BALLOONS BEFORE THE SNARE WAS SUCCESSFULLY ADVANCED ALL THE WAY TO THE WIRE FRAGMENT. DESPITE MULTIPLE ATTEMPTS, THE PHYSICIAN WAS UNABLE TO GRIP THE WIRE FRAGMENT WITH THE SNARE. HE SUBSEQUENTLY REVIEWED THE PRE- AND POST-ANGIOGRAMS AND DETERMINED THAT THE SMALL VESSEL WHICH IS BLOCKED BY THE WIRE FRAGMENT IS INSIGNIFICANT, AND THAT THE AREA OPENED UP DURING THE DIAMONDBACK INTERVENTION HAD IMPROVED THE BLOOD SUPPLY TO THE FOOT. THE PATIENT'S FOOT IS NOW PINK AND WARM AND THE PATIENT SAYS HIS FOOT "FEELS BETTER THAN IT HAS IN A LONG TIME." THE PHYSICIAN KEPT THE PATIENT OVERNIGHT FOR OBSERVATION AND EARLY THE NEXT MORNING REPORTED THAT THE PATIENT SAID THAT "FOR THE FIRST TIME IN MONTHS AND MONTHS AND MONTHS HE DIDN'T HAVE PAINT IN HIS TOE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAMONDBACK 360 ORBITAL ATHERECTOMY SYSTEM MCW CARDIOVASCULAR SYSTEMS, INC. GW-14335-FRM P1997727

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R 2.5MM MAVERICK PTCA BALLOON| 2.0MM MAVERICK PTCA BALLOON| 7 FR RAABE INTRODUCER SHEATH| 1.5MM MAVERICK PTCA BALLOON| .035" GLIDE CATHETER| .014" MAILMAN WIRE| .014" COUGAR WIRE