BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIOSCULPT PTCA SCORING BALLOON CATHETER (EX)

    MDR report key: 1901459 · Received November 11, 2010

    Report

    Report Number
    3005462046-2010-00017
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 12, 2010
    Manufacturer
    ANGIOSCORE, INC.
    Product Code
    NWX
    PMA / PMN Number
    P050018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: PRODUCT DISPOSED BY HOSPITAL, THUS UNABLE TO EVALUATE DEVICE. PROCEDURAL PHYSICIAN AT THE CASE VERBALLY STATED THAT THE PERFORATION MAY HAVE BEEN CAUSED BY INAPPROPRIATE SIZING OF THE STENT THAT WAS USED POST ANGIOSCULPT PROCEDURE, NOT BY THE ANGIOSCULPT, AND THAT THE VESSEL "LOOKED FINE" AFTER HE USED THE ANGIOSCULPT. HOWEVER, UPON FOLLOW-UP, THE PHYSICIAN DECLINED TO PROVIDE FURTHER INFORMATION. CORONARY ARTERY PERFORATION/INJURY IS A POTENTIAL ADVERSE EFFECT OF PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY PROCEDURES AND IS LISTED IN THE ANGIOSCULPT DEVICE IFU.

    Description of Event or Problem · 1

    THE PHYSICIAN FIRST TREATED THE RCA (AND DID NOT USE AN ANGIOSCULPT IN THIS VESSEL). HE THEN WORKED ON A CIRCUMFLEX ARTERY. HE USED A 2.0 X 10 ANGIOSCULPT EX OVER A BMW. AFTER USING THE ANGIOSCULPT, HE PROVIDED POSITIVE FEEDBACK ON ITS PERFORMANCE. THEN, THERE WAS A PERFORATION THAT WAS OBSERVED DURING STENTING WITH A 2.5 X 15. HE QUICKLY ASKED THE STAFF FOR EQUIPMENT. MORE STAFF ARRIVED AND THEY WORKED ON THE PATIENT IN THE ROOM AND THEN TOOK HER TO SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANGIOSCULPT PTCA SCORING BALLOON CATHETER (EX) NWX ANGIOSCORE, INC. 2034-2010 F10010013

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention