BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOXCROSS PTA CATHETER

    MDR report key: 1904600 · Received November 22, 2010

    Report

    Report Number
    9710478-2010-00141
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 28, 2010
    Report Date
    October 28, 2010
    Manufacturer
    AV-BERINGEN
    Product Code
    LIT
    PMA / PMN Number
    K081417
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IN THIS CASE THE BALLOON RUPTURE WAS MOST LIKELY CAUSED BY THE MILD CALCIFIED LESION. A REVIEW OF THE LOT HISTORY RECORD FOR THIS DEVICE DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT. ACCORDING TO THIS INVESTIGATION NO EVIDENCE COULD BE FOUND WHICH SUPPORTS THE ASSUMPTION THAT A DEVICE ISSUE CONTRIBUTED TO THE BALLOON RUPTURE.

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THAT THE DEVICE WAS DISCARDED. THE LOT NUMBER WAS PROVIDED. REVIEW OF THE LOT HISTORY RECORD IS FORTHCOMING. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF A MILDLY CALCIFIED LESION, THE FOXCROSS BALLOON WAS INFLATED FOR THE FIRST TIME, BUT THE PRESSURE DID NOT INCREASE. THE PHYSICIAN SUSPECTS THAT THE BALLOON WAS RUPTURED. THERE WAS NO PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FOXCROSS PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-BERINGEN 658055

    Patients

    Seq Age Sex Outcome Treatment
    1