BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SEQUITOR STEERABLE GUIDEWIRE

    MDR report key: 1821419 · Received August 26, 2010

    Report

    Report Number
    1226551-2010-00001
    Event Type
    Malfunction
    Date Received
    August 26, 2010
    Date of Event
    June 30, 2010
    Report Date
    August 24, 2010
    Manufacturer
    BIOSPHERE MEDICAL, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS STILL BEING EVALUATED BY MFR. A CONCLUSION CANNOT BE DRAWN AT THIS TIME; HOWEVER, IT APPEARS THAT NO MFG DEFECT CONTRIBUTED TO THIS MALFUNCTION. ADDITIONAL INFO WILL BE SUBMITTED IN A FOLLOW-UP REPORT. DHR REVIEW: THE DHR WAS OBTAINED FROM (B)(4). THE LOT HISTORY RECORD SHOWED THAT (B)(4) NON CONFORMITIES WERE FOUND THROUGHOUT THE MFG AND INSPECTION PROCESS. (B)(4). NCR AND COMPLAINT REVIEW: THERE HAVE BEEN NO OTHER CUSTOMER COMPLAINTS RECORDED FOR THIS LOT AT INC. THERE HAVE BEEN NO NCR'S RECORDED FOR THIS LOT AT INC. INVESTIGATION RESULTS: (B)(4). THE GUIDEWIRES WERE APPROVED FOR RELEASE BY (B)(4) AND ALSO BY BIOSPHERE MEDICAL INC. THIS WIRE WAS NOT MFG IN ANY WAY THAT WOULD CAUSE THE TWO PARTS TO SEPARATE. THE TWO PARTS SEPARATED DUE TO A HEAVY TENSIONAL LOAD. THE DIRECT CAUSE FOR THE HIGH LOAD IS UNK. THE WIRE WILL BE SENT TO (B)(4) TO UNDERGO ADDITIONAL TESTING. THE RESULTS OF THIS INVESTIGATION ARE INCLUSIVE AT THIS TIME.

    Description of Event or Problem · 1

    ON JULY 29, 2010, BIOSPHERE MEDICAL, INC. BECAME AWARE OF AN INCIDENT INVOLVING A (B)(6) FEMALE PT. ON (B)(6) 2010, PT RECEIVED A LIVER TRANSPLANT. PER PHYSICIAN, AN STENOSIS APPEARED AT THE LEVEL OF ANASTOMOSIS BETWEEN THE TRANSPLANTED HEPATIC ARTERY AND THE HEPATIC ARTERY OF THE PT. THE PHYSICIAN DECIDED TO STENT THIS STENOSIS WITH A TSUNAMI TERUMO STENT (6.0 DIAMETER, 18MM LENGTH). THE GUIDEWIRE RECOMMENDED BY TERUMO IS A 0.018" AND PHYSICIAN CHOSE THE BIOSPHERE MEDICAL, INC. SEQUITOR STEERABLE GUIDEWIRE (SEQUITOR), WHICH IS A 0.018" GUIDEWIRE. A GUIDING CATHETER WAS INTRODUCED OVER THE GUIDEWIRE, AND THEN THE STENT PROGRESSED OVER THE SEQUITOR GUIDEWIRE THROUGH THE GUIDING CATHETER (NOT A BIOSPHERE PRODUCT) AND WAS DELIVERED OUT OF THE GUIDING CATHETER (NOT A BIOSPHERE PRODUCT). THE SEQUITOR GUIDEWIRE BROKE AT THE EXTREMITY AFTER THE STENT WAS DELIVERED. THE PHYSICIAN SUCCESSFULLY RETRIEVED THE BROKEN PIECE OF THE SEQUITOR. THE PHYSICIAN REPORTED THAT THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEQUITOR STEERABLE GUIDEWIRE WIRE, GUIDE, CATHETER DQX BIOSPHERE MEDICAL, INC. 90014338

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR