BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH PKGD: BERMAN 5 FR 8 0CM

    MDR report key: 2043159 · Received February 24, 2011

    Report

    Report Number
    2242445-2011-00027
    Event Type
    Malfunction
    Date Received
    February 24, 2011
    Date of Event
    February 8, 2011
    Report Date
    February 18, 2011
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQO
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE THE CATHETER WAS IN USE, THE CATHETER BODY BURST UNDER HIGH PRESSURE. AS A RESULT, THE CATHETER WAS REMOVED FROM THE PATIENT (PT.) INTACT. THERE WAS NO DELAY IN TREATMENT, NO PT DEATH AND NO PT COMPLICATIONS WERE REPORTED. ADDITIONAL INFO RECEIVED BY THE HOSPITAL ADMINISTRATIVE ASSISTANT ON (B)(6) 2011 STATED THEY DO NOT DOCUMENT IN THEIR CASE NOTES THE PERCUTANEOUS SHEATH INTRODUCER (PSI) THAT IS USED. THEY REPEAT BACK TO THE DOCTORS THE VOLUME, FLOW RATE AND PSI PRIOR TO EACH INJECTION AND GET VERIFICATION TO ENSURE SAFETY. RANGES FOR ALL CATHETERS ARE ATTACHED TO THE INJECTOR AND VERIFIED ON EACH CATHETER'S PACKAGE PRIOR TO USE. WHEN THIS FIRST OCCURRED THEY TRIED USING TWO ADDITIONAL KITS WITH THE SAME OUTCOME. AS A RESULT, A SHORTER 5-50 BERMAN WAS USED SUCCESSFULLY FOR THE PT. THE SHAFT THAT BURST WAS OUTSIDE THE PT'S BODY SO THERE WAS NO HARM TO THE PT. REFERENCE MDR #2242445-2011-00025 FOR THE FIRST EVENT AND MDR #2242445-2011-00026 FOR THE SECOND EVENT INVOLVING THE SAME PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH PKGD: BERMAN 5 FR 8 0CM BERMAN ANGIOGRAPHIC CATHETER PRODUCTS DQO ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR