BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPLATZ SUPER STIFF?

    MDR report key: 4772392 · Received May 14, 2015

    Report

    Report Number
    2134265-2015-03292
    Event Type
    Injury
    Date Received
    May 14, 2015
    Date of Event
    March 26, 2014
    Report Date
    May 8, 2015
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K843012
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT IDENTIFIER: (B)(4). DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4) STUDY. IT WAS REPORTED THAT DURING AN AORTIC VALVE IMPLANT PROCEDURE, SMALL CHORDAL RUPTURE OCCURRED. THE PATIENT WAS ENROLLED INTO THE (B)(4) STUDY ON (B)(6) 2014. DURING THE PROCEDURE, SMALL CHORDAL RUPTURE WAS NOTED DURING THE INTRA-PROCEDURAL TRANSESOPHAGEAL ECHOCARDIOGRAPHY. PER SITE'S RESPONSE, THE CHORDAL RUPTURE COULD BE ATTRIBUTED TO THE AMPLATZ SUPER STIFF GUIDEWIRE AND/OR THE NOSE CONE OF THE DELIVERY CATHETER USED DURING THE PROCEDURE. NO ACTION WAS TAKEN. AT THE TIME OF REPORTING, THE OUTCOME OF THE EVENT WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317070 AMPLATZ SUPER STIFF? WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK852

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other 23MM LOTUS VALVE SYSTEM