BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PACING/PSI KIT: 5 FR/6 FR 2-L

    MDR report key: 4697495 · Received April 15, 2015

    Report

    Report Number
    3010532612-2015-00012
    Event Type
    Malfunction
    Date Received
    April 15, 2015
    Date of Event
    March 25, 2015
    Report Date
    March 25, 2015
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    LDF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QN#(B)(4). SIMILAR PRODUCTS SOLD IN THE USA: AI-07155-KS-510K-K960479; AI-07155-UPM-510K-K945229.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON RUPTURED IN THE PATIENT DURING WIRE INSERTION. THERE IS NO PATIENT INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    251451 PACING/PSI KIT: 5 FR/6 FR 2-L TEMPORARY PACING PRODUCT LDF ARROW INTERNATIONAL INC. 23F14G0657

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention