BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSAR-18

    MDR report key: 7378182 · Received March 28, 2018

    Report

    Report Number
    1028232-2018-01064
    Event Type
    Malfunction
    Date Received
    March 28, 2018
    Report Date
    March 16, 2018
    Manufacturer
    BIOTRONIK AG
    Product Code
    NIP
    PMA / PMN Number
    P160025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE WORST, BUT UNLIKELY CASE, THE TIP COULD COME OFF THE DEVICE DURING THE PROCEDURE, EMBOLIZE DISTALLY AND LEAD TO ARTERY OBSTRUCTION. AS A CAUTIONARY MEASURE BIOTRONIK IS WITHDRAWING THE CONCERNED LOTS FROM THE MARKET. THIS VOLUNTARY FIELD SAFETY CORRECTIVE ACTION AFFECTS ONLY THE LOTS OF THE PULSAR-18 STENT SYSTEMS LISTED AND NO OTHER PULSAR-18 STENT SYSTEM LOTS.

    Description of Event or Problem · 1

    OUS MDR - IT WAS DETERMINED THAT DUE TO A MANUFACTURING ISSUE, PULSAR-18 STENT SYSTEMS FROM THE LOTS LISTED DID NOT MEET THE SPECIFICATIONS FOR THE TIP TENSILE STRENGTH. NO COMPLAINTS OR PATIENT INCIDENTS RELATED TO THIS ISSUE HAVE BEEN REPORTED TO BIOTRONIK SO FAR. THIS IS A LIST OF SIZE, MODEL NUMBERS AND LOT NUMBERS AFFECTED: SIZE: 7/40/135 MODEL: 377493 LOT: 12173610, SIZE: 4/20/135 MODEL: 377476 LOT:12174145, SIZE: 6/20/135 MODEL: 377486 LOT: 12174146, SIZE: 6/150/90 MODEL: 366820 LOT: 12174363, SIZE: 5/170/90 MODEL: 366816 LOT: 01180140, SIZE: 6/100/90 MODEL: 355818 LOT: 01180366, SIZE: 6/100/90 MODEL: 366818 LOT: 01180381, SIZE: 6/100/90 MODEL: 366818 LOT: 01180465, SIZE: 5/120/135 MODEL: 366834 LOT: 01181147, SIZE: 7/100/135 MODEL: 366843 LOT: 01181148, SIZE: 4/100/135 MODEL: 366828 LOT: 01182456, SIZE: 6/20/135 MODEL: 377486 LOT: 01182837. NO LOTS SHIPPED TO THE US WERE AFFECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222793 PULSAR-18 STENT, SUPERFICIAL, FEMORAL ARTERY NIP BIOTRONIK AG 366818 01180465

    Patients

    Seq Age Sex Outcome Treatment
    1