BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MUSTANG PTA BALLOON DILATATION CATHETER

    MDR report key: 2993516 · Received March 7, 2013

    Report

    Report Number
    2134265-2013-01955
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 6, 2013
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LIT
    PMA / PMN Number
    K103751
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MFR REPORT #: 2134265-2013-01184. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY TREATMENT PROCEDURE A PULMONARY EMBOLISM OCCURRED. THE PATIENT PRESENTED WITH THROMBUS OF THE PROXIMAL - MID SUPERFICIAL FEMORAL ARTERY (SFA). A 7X60X120 EPIC VASCULAR STENT WAS SUCCESSFULLY IMPLANTED AT THE MID SFA. POST DILATION PERFORMED WITH A MUSTANG BALLOON CATHETER, 2 INFLATIONS/20 ATMS EACH WITH GOOD RESULTS. PROCEDURE CONTINUED ONTO THE PROXIMAL SFA AND A SEGMENT AT THE BIFURCATION WHERE "A LOT" OF THROMBUS WAS NOTED. TREATMENT WAS ADMINISTERED WITH ANGIOJET. ANGIOGRAPH PERFORMED AND A NO FLOW WAS NOTED. ANGIOJET TREATMENT ADMINISTERED. ANGIOGRAPH REVEALED RESTORED FLOW. THE PHYSICIAN WAS SATISIFIED WITH THE RESULTS BUT NOTED SLIGHT THROMBUS STILL PRESENT A PORTION OF THE UNTREATED SFA. PATIENT CODE WITH PRESSURE DROP. CHEST COMPRESSION ADMINISTERED AND THE PATIENT STABLIZED. PHYSICIAN NOTED THAT PORTION OF THROMBUS HAD MIGRATED JUST PROXIMAL TO THE PROFUNDA AND SFA AND A PULMONARY EMBOLISM OCCURRED. PATIENT WAS TAKEN TO CCU AND TREATED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED. THE PATIENT WAS HOSPITALIZED AND IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97257 MUSTANG PTA BALLOON DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT BOSTON SCIENTIFIC - GALWAY UNK696

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention