BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1662886 · Received April 10, 2010

    Report

    Report Number
    2024168-2010-00799
    Event Type
    Malfunction
    Date Received
    April 10, 2010
    Date of Event
    March 24, 2010
    Report Date
    March 25, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE BALLOON CATHETER WAS NOT RETURNED. ONLY THE CHIPBOARD BOX AND TYVEK POUCH WAS RETURNED. THE CLEAR TAPE ON THE CHIPBOARD BOX WAS BROKEN. THE TYVEK POUCH WAS PEELED OPENED AT THE PEEL AWAY SEAL. THE LABEL DESCRIPTION ON THE TYVEK POUCH READS; SIZE: 3.5 X 12MM, PART NUMBER: 1011756-12 AND LOT NUMBER: 9102661. THE LABEL DESCRIPTION OF THE CHIPBOARD BOX READS; SIZE: 3.0 X 15MM, PART NUMBER: 1011754-15 AND LOT NUMBER: 9110961. BOTH LABEL DESCRIPTIONS DID NOT MATCH. ONLY THE CHIPBOARD BOX AND TYVEK POUCH WERE RETURNED FOR ANALYSIS AND THE BALLOON CATHETER WAS NOT RETURNED. THE CLEAR TAPE ON THE CHIPBOARD BOX WAS BROKEN AND THE TYVEK POUCH WAS PEELED OPEN AT THE PEEL AWAY SEAL. THE INCONSISTENT LABELING WAS CONFIRMED DURING ANALYSIS. THE LABEL DESCRIPTION OF THE CHIPBOARD BOX LISTS THE SIZE AS 3.0X15MM, THE PART NUMBER AS 1011754-15 AND THE LOT NUMBER AS 9110961. THE LABEL DESCRIPTION ON THE TYVEK POUCH LISTS THE SIZE AS 3.5X12MM, THE PART NUMBER AS 1011754-12 AND THE LOT NUMBER AS 9102661. DURING REVIEW OF BOTH PART AND LOT NUMBER COMBINATION'S FINISHED PRODUCT LOT HISTORY RECORD (LHR)S, NO NONCONFORMING MATERIAL RECORDS (NCMR) WERE GENERATED THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT AND NEITHER LOT HAD SIMILAR INCIDENTS REPORTED FOR PRODUCT SIZE MIX UPS OR MISLABELING. FURTHER REVIEW INDICATES THAT BOTH LOTS WERE MANUFACTURED ON THE SAME MANUFACTURING LINE; HOWEVER, BOTH LOTS WERE PACKAGED, LABELED, CHIPBOARD BOXED AND CORRUGATED BOXED ON DIFFERENT DAYS AND NEITHER OF THE LOTS WERE REWORKED PRIOR TO SHIPMENT. REVIEW OF THE SHIPMENT RECORDS INDICATE THAT UNITS FROM BOTH LOTS WERE SHIPPED TO THE ACCOUNT THAT REPORTED THIS COMPLAINT ON DIFFERENT DATES. IN THIS CASE, IT IS POSSIBLE THAT THE 3.5X12MM VOYAGER NC DEVICE WAS PACKAGED IN A 3.0X15MM VOYAGER NC CHIPBOARD BOX DURING MANUFACTURING OR WAS INADVERTENTLY MIS-PACKAGED AT THE ACCOUNT. HOWEVER, SINCE IT WAS REPORTED THAT THE TAPE SEAL WAS BROKEN ON THE CHIPBOARD BOX PRIOR TO REMOVAL OF THE PRODUCT AND THERE WAS NO EVIDENCE OF A SECOND TAPE SEAL, MANUFACTURING WILL BE NOTIFIED OF THIS MISLABELING FOR FURTHER INVESTIGATION. AS CORRECTIVE ACTION, FIELD DISCREPANCY NOTIFICATION, WAS INITIATED ON 04/02/2010. ALL FURTHER INVESTIGATION INTO THE ROOT CAUSE, THE NEED FOR REMEDIAL ACTION AND ANY CORRECTIVE ACTIONS WILL BE DOCUMENTED AND TRACKED IN THE FDN. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES.

    Description of Event or Problem · 1

    DEVICE MALFUNCTION: INCONSISTENT HUB AND PACKAGE DEVICE IDENTIFICATION. TIME OF DEVICE MALFUNCTION: BEFORE USE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT THE DEVICE WAS REMOVED FROM THE BOX THAT WAS LABELED AS A 3.0 X 15 NC VOYAGER AND THE NURSE NOTED THAT THE HUB OF THE DEVICE WAS LABELED A 3.5 X 12 NC VOYAGER. THE NURSES CONFIRMED THAT SHE BROKE THE TAPE SEAL OF THE BOX. THE POUCH IS LABELED THE SAME AS THE HUB 3.5 X 12 VOYAGER. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER LOX ABBOTT VASCULAR-CARDIAC THERAPIES NA 9110961

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR