BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MANDREL GUIDEWIRES OR M-WIRES

    MDR report key: 6840276 · Received September 1, 2017

    Report

    Report Number
    2939520-2017-00074
    Event Type
    Injury
    Date Received
    September 1, 2017
    Date of Event
    August 2, 2017
    Report Date
    August 2, 2017
    Manufacturer
    LAKE REGION MFG., INC
    Product Code
    DQX
    UDI-DI
    00845225002763
    PMA / PMN Number
    K080144
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO PHILIPS VOLCANO POLICY. ATTEMPT TO OBTAIN "PATIENT WEIGHT" WAS UNSUCCESSFUL AS THE WEIGHT WAS NOT RECORDED. ALL REASONABLY KNOWN PATIENT INFORMATION IS INCLUDED IN THIS REPORT. ADDITIONAL INFORMATION: THE PHYSICIAN WIRED DOWN TO THE ANTERIOR TIBIAL (AT) WITH A LIGHT SUPPORT WIRE. THE TARGET LESION WAS IN THE PROXIMAL AT. THIS PATIENT HAD AN ABRUPT JUNCTION BETWEEN THE AT AND THE TIBIAL PERONEAL TRUNK (TPT) WHICH MADE THE TAKEOFF OF THE AT STEEP. THE GUIDEWIRE WAS BIASING TOWARD THE CARINA OF THE TPT/AT JUNCTION AND COULD HAVE BEEN SUB-INTIMAL AT THIS LOCATION. THIS IS WHERE A PERFORATION OCCURRED DURING ATHERECTOMY*. PER THE ANALYSIS OF THE 0.14 GUIDEWIRE, VESSEL TISSUE WAS FOUND WRAPPED AROUND THE .014 GUIDEWIRE. TREATMENT WAS NOT COMPLETED BY THE PROCEDURE. NO DAMAGE WAS NOTED DURING PREP. RESISTANCE WAS FELT ON THE 2ND PASS (ONLY MADE 2 PASSES). DEVICE APPEARED INTACT AFTER REMOVAL FROM THE PATIENT AND NO DAMAGE WAS OBSERVED. THE CATHETER* WAS REMOVED WITH DIFFICULTY FIRST, AFTER MULTIPLE ATTEMPTS, TO BUDDYWIRE, EXCHANGE THROUGH CROSSING CATHETER, BALLOONS, PHYSICIAN FINALLY HAD TO REMOVE THE GUIDEWIRE. NOTHING WOULD ADVANCE PAST A CERTAIN POINT ON THE WIRE. * THE ATHERECTOMY CATHETER NOTED IS MANUFACTURED BY PHILILPS VOLCANO AND AN INITIAL REPORT WAS SUBMITTED SEPARATELY TO THE FDA UNDER MDR 2939520-2017-00073 ON 09-01-2017 ((B)(4)). NO TESTS/LABORATORY DATA WAS AVAILABLE. A SERIAL NUMBER IS NOT APPLICABLE TO THIS DEVICE. THE IMPLANT OR EXPLANT DATES ARE NOT APPLICABLE TO THIS DEVICE. THE DEVICE WAS INVESTIGATED BY THE DISTRIBUTOR. THE GUIDEWIRE WAS EXAMINED WHICH REVEALED TISSUE WRAPPED AROUND THE DISTAL TIP SECTION OF THE WIRE. THE REST OF THE WIRE WAS UNAFFECTED. ON THE COILED DISTAL SECTION OF THE WIRE THERE WAS EVIDENCE THAT THE COILS WERE STRETCHED DUE TO THE PHYSICIAN TRYING TO FEED THE ATHERECTOMY CATHETER AND BALLOONS OVER THE WIRE WHILE MEETING RESISTANCE FROM THE WRAPPED TISSUE. THE DEVICE FUNCTIONED AS INTENDED. FOREIGN MATERIAL (VESSEL TISSUE) WAS PRESENT ON THE GUIDEWIRE WHICH PREVENTED THE PASSAGE OF THE ATHERECTOMY CATHETER AND BALLOON CATHETERS. MANUFACTURING DATE IS PENDING. THE MANUFACTURING DOCUMENTATION FOR THIS DEVICE WAS REVIEWED AND THE DEVICE MET ALL QUALITY AND MANUFACTURING RELEASE CRITERIA. THERE WERE NO NONCONFORMING MATERIAL REPORTS OR DEVIATIONS NOTED THAT WOULD CONTRIBUTE TO THE REPORTED FAILURE MODE. THIS COMPLAINT WILL BE MONITORED AS PART OF COMPLAINT DATA ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED FOR A THERAPEUTIC PERIPHERAL PROCEDURE THE USER PLUGGED IN ATHERECTOMY CATHETER DEVICE, FLUSHED, MADE ONE PASS THAT WAS FINE, AND CAME BACK TO MAKE THE SECOND PASS. THE ATHERECTOMY DEVICE ALMOST STOPPED. THE PHYSICIAN PULLED BACK SLIGHTLY AND GOT IT TO WORK. WHEN THEY TRIED TO ADVANCE, IT WAS LIKE THERE WAS A BLOCKAGE. THEY STOPPED, PULLED THE ATHERECTOMY DEVICE AND DID ANGIOGRAM AND SAW THE THERE WAS A SUBSTANCE ON THE WIRE. THEY THEN TRIED TO ADVANCE A BALLOON DOWN THE WIRE AND IT WOULD NOT GO. THEY TRIED ADVANCING IT [THE CATHETER] AGAIN BUT WAS UNABLE. WHEN THEY PULLED THE WIRE THEY SAW SOMETHING ON THE WIRE THAT HAD BEEN PREVENTING THE PASS. PATIENT EXPERIENCED AN EVENT OF PERFORATED ARTERY AT ANTERIOR TIBIAL. PATIENT WAS RELEASED AS EXPECTED IN STABLE CONDITION. ON (B)(6) 2017 THE MANUFACTURER'S REPRESENTATIVE REPORTED THE PATIENT WAS ADMITTED TO THE HOSPITAL POST-PROCEDURE. VESSEL: 99% OCCLUSION, LOCATED ANTERIOR TIBIAL, MODERATELY CALCIFIED. THIS EVENT IS BEING REPORTED BECAUSE THERE WAS A PATIENT EVENT DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618856 MANDREL GUIDEWIRES OR M-WIRES WIRE, GUIDE, CATHETER DQX LAKE REGION MFG., INC PG14300LF 10643211 00845225002763

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| O| R