BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LINK MINI VISION OTW CORONARY STENT SYSTEM

    MDR report key: 1381703 · Received March 16, 2009

    Report

    Report Number
    2024168-2009-00439
    Event Type
    Malfunction
    Date Received
    March 16, 2009
    Date of Event
    December 22, 2008
    Report Date
    December 22, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    MAF
    PMA / PMN Number
    PO20047
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO PERFORM AN EVALUATION AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION. EVALUATION SUMMARY: DURING THE QUALITY CONTROL INSPECTION OF THE REPACKAGING PROCESS, IT WAS DISCOVERED THAT ONE OF THE UNITS CONTAINED A PROXIMAL ADAPTOR (SIDEARM) THAT DID NOT MATCH THE PRODUCT SIZE ON THE LABEL. ALL LABELS (CHIPBOARD BOX AND POUCH) STATED THAT THE PRODUCT SIZE WAS A 2.5 X 18 MM. THE SIZE MARKED ON THE PROXIMAL ADAPTOR WAS 2.25 X 23 MM. THE NOMINAL STENT OUTER DIAMETER AND BALLOON WORKING LENGTH MEASUREMENTS WERE TAKEN ON THE PART TO CONFIRM THE PRODUCT SIZE TO BE 2.5 X 18 MM. THEREFORE THE SIZE MARKED ON THE PROXIMAL ADAPTOR WAS INCORRECT, BUT THE PRODUCT AND ALL OTHER LABELS ON THE PRODUCT WERE CORRECT. PRODUCT PERFORMANCE ENGINEERING WAS UNABLE TO PERFORM AN EVALUATION AT THE TIME OF THIS REPORT. RESULTS AND CONCLUSIONS WILL BE FORWARDED UPON COMPLETION.

    Description of Event or Problem · 1

    REPORTING STATUS: MALFUNCTION. REPORTING RATIONALE: THIS MISLABELING MAY IMPACT DEVICE TRACKING. DEVICE ISSUE: MISLABELED. ON DECEMBER 22, 2008, ABBOTT VASCULAR'S INTERNAL REWORK DEPARTMENT IDENTIFIED ONE OUT OF TWO ADMINISTRATIVELY RETURNED UNITS THAT HAD THE INCORRECT BALLOON SIZE ON THE SIDEARM. THE PART NUMBER IS 1010154-18, LOT NUMBER 6092231, MINI VISION OTW 2.5X18 MM US. A NONCONFORMING MATERIAL REPORT WAS INITIATED ON DECEMBER 23, 2008. THE TWO UNITS WERE RECEIVED BACK TO ABBOTT VASCULAR'S REWORK DEPARTMENT ON DECEMBER 22, 2008, WITH NO CUSTOMER COMPLAINT. THESE UNITS WERE RETURNED AND IDENTIFIED FOR REPACKAGING VIA ABBOTT'S RETURNED GOODS PROCESS. DURING THE QUALITY CONTROL INSPECTION OF THE REPACKAGING PROCESS, IT WAS DISCOVERED THAT ONE OF THE UNITS CONTAINED A PROXIMAL ADAPTOR (SIDEARM) THAT DID NOT MATCH THE PRODUCT SIZE ON THE LABEL. ALL LABELS (CHIPBOARD BOX AND POUCH) STATED THAT THE PRODUCT SIZE WAS A 2.5 X 18 MM. THE SIZE MARKED ON THE PROXIMAL ADAPTOR WAS 2.25 X 23 MM. THE NOMINAL STENT OUTER DIAMETER AND BALLOON WORKING LENGTH MEASUREMENTS WERE TAKEN ON THE PART TO CONFIRM THE PRODUCT SIZE TO BE 2.5 X 18 MM. THEREFORE, THE SIZE MARKED ON THE PROXIMAL ADAPTOR WAS INCORRECT, BUT THE PRODUCT AND ALL OTHER LABELS ON THE PRODUCT WERE CORRECT. THIS IS BELIEVED TO BE AN ISOLATED EVENT AND DOES NOT INVOLVE ANY ADDITIONAL PRODUCT FROM THIS LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LINK MINI VISION OTW CORONARY STENT SYSTEM 74MAF MAF ABBOTT VASCULAR-CARDIAC THERAPIES NA 6092231

    Patients

    Seq Age Sex Outcome Treatment
    1 NA