BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH PKGD: BERMAN 6 FR 90CM

    MDR report key: 4152515 · Received October 6, 2014

    Report

    Report Number
    3010532612-2014-00022
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 22, 2014
    Report Date
    September 23, 2014
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DYG
    PMA / PMN Number
    K892530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    REF MDR #3010532612-2014-00023 FOR THE FIRST EVENT INVOLVING THE SAME PT. IT WAS REPORTED THAT THE SECOND EVENT OCCURRED WHILE IN THE PEDIATRIC CARDIOLOGY DEPARTMENT DURING USE. THE PHYSICIAN INSERTED THE AI-07136 IN THE RIGHT FEMORAL VEIN. WHEN INJECTING THE CONTRAST MEDIUM (500 PSI) THE BALLOON BROKE. AS A RESULT, THE DEVICE WAS REMOVED. A NEW KIT WAS OPENED AND INSERTED WITHOUT ISSUE. THE PHYSICIAN DID NOT CHANGE THE INSERTION SITE BECAUSE THE SHEATH WAS NOT WITHDRAWN YET. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY USING THE THIRD PRODUCT. THERE WAS NO PT DEATH, COMPLICATIONS OR INJURY REPORTED. NO MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THERE WAS A DELAY OR INTERRUPTION IN THERAPY WITH NO HARM TO THE PT NOTED. AN UPDATE RECEIVED 10/02/2014 STATED THAT THE CONTRAST MEDIUM MAXIMUM INJECTING IS 650 PSI. HOWEVER THE PHYSICIAN JUST INJECTED 500 PSI CONTRAST MEDIUM AND FOUND OUT REFLUX THROUGH THE X-RAY. HE THOUGHT THE BALLOON MIGHT BE BROKEN. AFTER WITHDRAWAL, THE BALLOON BREAKAGE WAS CONFIRMED. THEY WERE UNABLE TO OBSERVE IF THE BALLOON WAS ASYMMETRICAL DURING THE X-RAY,

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622117 CATH PKGD: BERMAN 6 FR 90CM BERMAN ANGIOGRAPHIC CATHETER PRODUCT DYG ARROW INTERNATIONAL INC. 16F14C0079

    Patients

    Seq Age Sex Outcome Treatment
    1