BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROMUS PREMIER¿

    MDR report key: 4963213 · Received August 4, 2015

    Report

    Report Number
    2134265-2015-04993
    Event Type
    Malfunction
    Date Received
    August 4, 2015
    Report Date
    July 8, 2015
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    NIQ
    PMA / PMN Number
    P110010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS A COMBINATION PRODUCT. (B)(4). DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS RECEIVED FOR ANALYSIS AND WAS CONTAINED WITHIN THE CARTON WITH THE BLUE CLOSURE STRIP PEALED AWAY. NO EVIDENCE OF STRUCTURAL DAMAGE TO THE CARTON WAS EVIDENT AND THE CARTON LABEL WAS FULLY LEGIBLE AND ACCURATE. THE CARTON WAS THEN OPENED DURING EXAMINATION TO REVEAL THE FOIL POUCH PACKAGING & DFU. THERE WAS NO EVIDENCE OF DAMAGE TO THE FOIL POUCH PACKAGING OR THE DFU. THERE WAS NO EVIDENCE OF COMPROMISE TO THE PRODUCT STERILITY OR FUNCTIONALITY AS A RESULT OF THIS ISSUE. NO OTHER ISSUES WERE IDENTIFIED DURING THE PRODUCT ANALYSIS. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS CONSIDERED HANDLING DAMAGE AS THE EVENT OCCURRED WITHOUT DIRECT PATIENT CONTACT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 24 X 3.50 PROMUS PREMIER DRUG ELUTING STENT PACKAGE SEALS WERE OPEN DURING UNPACKING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 24 X 3.50 PROMUS PREMIER¿ DRUG ELUTING STENT PACKAGE SEALS WERE OPEN DURING UNPACKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509190 PROMUS PREMIER¿ STENT, CORONARY, DRUG-ELUTING NIQ BOSTON SCIENTIFIC - GALWAY H7493925124350 0017539253

    Patients

    Seq Age Sex Outcome Treatment
    1