BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER

    MDR report key: 2983241 · Received February 28, 2013

    Report

    Report Number
    9616099-2013-00103
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    January 28, 2013
    Report Date
    February 8, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. THIS IS ONE OF THREE PRODUCTS USED DURING THE SAME PROCEDURE. PLEASE REFERENCE MFR. REPORT # 9616099-2013-00102, # 9616099-2013-00103, AND # 9616099-2013-00104.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE THREE (3) DEVICES/PI'S INCLUDED IN THIS FILE/SR WERE USED IN THREE (3) DIFFERENT PATIENT'S/CASES. AS SUCH, THIS PI WILL BE VOIDED. THE PRODUCT REPORTED UNDER THIS PI/REPORT WILL BE CAPTURED UNDER (B)(4). NO ADDITIONAL INFORMATION WILL BE FORTHCOMING.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT THE THREE (3 EACH) 80 CM. POWERFLEX PRO 7 MM. X 4 CM. BALLOON CATHETERS USED DURING THE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY/PTA OF A DIALYSIS SHUNT TARGET LESION WERE DIFFICULT TO WITHDRAW THROUGH THE SHEATH. IT WAS REPORTED THAT AFTER DEFLATION OF THE DEVICES UNDER VACUUM WITH AN INDEFLATOR, THE BALLOONS BECAME STOCKED PRIOR TO ENTERING THE SHEATH USED. THE PHYSICIAN WAS ABLE TO WITHDRAW THE CATHETERS THROUGH THE SHEATH USING FORCE. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88349 POWERFLEX PRO PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER PTA CATHETERS DQY CORDIS DE MEXICO NA 15705790

    Patients

    Seq Age Sex Outcome Treatment
    1 TERUMO G/W .035