BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANGIOSCULPT PTA SCORING BALLOON CATHETER

    MDR report key: 1935062 · Received December 2, 2010

    Report

    Report Number
    3005462046-2010-00026
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 2, 2010
    Manufacturer
    ANGIOSCORE, INC.
    Product Code
    LIT
    PMA / PMN Number
    K100303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION IS RETURNING (AND IS CURRENTLY IN TRANSIT) TO ANGIOSCORE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO INCLUDE THE DEVICE EVAL INFO AND CODES. ALTHOUGH THE COMPANY IS SUBMITTING THIS MEDWATCH REPORT FOR A REPORTED DISTAL BOND PEEL, THE COMPANY BELIEVES THAT DISTAL BOND PEEL IS NOT REASONABLY LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY UPON RECURRENCE. THE COMPANY RECENTLY SUBMITTED AN MDR FOR A DISTAL BOND PEEL THAT RESULTED IN A SEPARATION, WHICH HAD OCCURRED POST-PROCEDURE (MDR # 3005462046-2010-00009). THUS, IN AN ABUNDANCE OF CAUTION, THE COMPANY IS SUBMITTING THIS MDR FOR A DISTAL BOND PEEL COMPLAINT.

    Description of Event or Problem · 1

    THE TARGET LESION WAS 75% DEGREE OF STENOSIS OF IN-STENT RESTENOSIS (ISR) LOCATED IN RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THE PHYSICIAN TREATED THE LESION USING 4.5X40MM OF STERLING MR. SUBSEQUENTLY, HE CHOSE THE ANGIOSCULPT AND DILATED THE LESION ONCE AT 10 ATMOSPHERES FOR 30 SECONDS. AFTER THE DILATION, HE NOTICED DISTAL TIP PEELING IN THE ANGIOSCULPT. THE PROCEDURE WAS FINISHED WHEN THIS EVENT OCCURRED. THERE WAS NO ADVERSE EVENT IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOSCULPT PTA SCORING BALLOON CATHETER LIT ANGIOSCORE, INC. 2076-4020 F10060024

    Patients

    Seq Age Sex Outcome Treatment
    1