BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH. PKGD: BERMAN 4 FR 5 0CM

    MDR report key: 2481134 · Received March 2, 2012

    Report

    Report Number
    2242445-2012-00038
    Event Type
    Malfunction
    Date Received
    March 2, 2012
    Date of Event
    February 20, 2012
    Report Date
    March 2, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQO
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CATH LAB, THE AI-07134 WAS PRETESTED PRIOR TO INSERTION AND THE BALLOON DID NOT FULLY INFLATE. AS A RESULT, ANOTHER AI-07134 WAS RETRIEVED FOR USE. THERE WAS NO REPORTED PATIENT DEATH OR INJURY. MEDICAL / SURGICAL INTERVENTION WAS NOT REQUIRED. ADDITIONAL INFORMATION RECEIVED ON (B)(4) 2012 STATED THAT THE BALLOON WAS PRETESTED BY USING THE SYRINGE THAT CAME WITH THE AI-07134. REFERENCE MDR NUMBER 2242445-2012-00039 FOR THE SECOND EVENT INVOLVING THE SAME PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH. PKGD: BERMAN 4 FR 5 0CM BERMAN ANGIOGRAPHIC CATHETER PRODUCTS DQO ARROW INTL., INC. MF1038674

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN