BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SELECTRA MPH-45

    MDR report key: 7467465 · Received April 26, 2018

    Report

    Report Number
    1028232-2018-01409
    Event Type
    Malfunction
    Date Received
    April 26, 2018
    Report Date
    April 18, 2018
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    DQY
    PMA / PMN Number
    K110461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS OF TODAY, THE MEDICAL DEVICE IS NOT AVAILABLE FOR ANALYSIS, THEREFORE THE DEVICE ITSELF COULD NOT BE INVESTIGATED. THE ANALYSIS IS THUS BASED ON THE INSPECTION OF THE PROVIDED PHOTOS WHICH WERE TAKEN DURING THE ATTEMPTED IMPLANTATION PROCEDURE AS WELL AS ON THE QUALITY DOCUMENTS ASSOCIATED WITH THE MANUFACTURE OF THIS PARTICULAR DEVICE. THE AVAILABLE PHOTOS OF THE SELECTRA MPH CATHETER USED DURING THE IMPLANTATION PROCEDURE SHOWED STRETCHED AREAS IN THE DISTAL REGION OF THE CATHETER. THE RE-INVESTIGATION OF THE MANUFACTURING PROCESS FOR THIS DEVICE SHOWED THAT THE PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY WITHOUT ANY INCONSISTENCIES DURING THE ASSEMBLY. IN SPITE OF THE AVAILABLE INFORMATION, NO DEFINITE CONCLUSION REGARDING THE ROOT CAUSE OF THIS OBSERVATION COULD BE DETERMINED. SHOULD ADDITIONAL INFORMATION OR THE DEVICE ITSELF BECOME AVAILABLE FOR ANALYSIS, THE INVESTIGATION WILL BE UPDATED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE AT THE MOMENT AND NO FURTHER INFORMATION IS EXPECTED. THE FILE IS CLOSED. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Description of Event or Problem · 1

    OUS MDR - THE MATERIAL OF THE DELIVERY SYSTEM WAS FOUND DAMAGED DURING THE PROCEDURE. AN EVENT DATE WAS NOT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308213 SELECTRA MPH-45 SELECTRA MULTIPURPOSE HOOK - 45 DQY BIOTRONIK SE & CO. KG 375533 08162329

    Patients

    Seq Age Sex Outcome Treatment
    1