BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1907068 · Received November 24, 2010

    Report

    Report Number
    2024168-2010-02522
    Event Type
    Malfunction
    Date Received
    November 24, 2010
    Date of Event
    November 3, 2010
    Report Date
    November 3, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CHIPBOARD BOX WAS RETURNED OPEN WITH EVIDENCE OF TWO PIECES OF TAPE ON THE BOX, INDICATING THAT IT MAY HAVE BEEN OPENED AND/OR RE-TAPED AT SOME POINT. THE LABEL DESCRIPTION ON THE CHIPBOARD BOX LISTED A 3.0 X 15 MM RX VOYAGER NC WITH PART NUMBER 1011754-15 AND LOT NUMBER 0022261. THE TYVEK POUCH WAS RETURNED SEALED WITH A VOYAGER NC BALLOON CATHETER INSIDE. THE POUCH WAS LABELED AS A 3.5 X 15 MM VOYAGER NC WITH PART NUMBER 1011756-15 AND LOT NUMBER 9122261. THE HUB (SIDEARM) OF THE DEVICE WAS ALSO LABELED AS A 3.5 X 15 MM VOYAGER NC WITH LOT NUMBER 9122261, WHICH MATCHES THE LABEL ON THE POUCH. THE BALLOON WAS PRESSURIZED TO NOMINAL PRESSURE (12 ATMOSPHERES) TO MEASURE THE OUTER DIAMETER OF THE BALLOON, INDICATING THAT THE CATHETER WAS IN FACT A 3.5 MM BALLOON. THIS CONFIRMS THE REPORTED COMPLAINT AS THE LABELING ON THE POUCH AND CATHETER DO NOT CORRESPOND WITH THE LABEL AFFIXED TO THE CHIPBOARD BOX. FACTORS THAT CAN POTENTIALLY CONTRIBUTE TO A MISLABELING DISCREPANCY/MIX-UP MAY INCLUDE, BUT ARE NOT LIMITED TO, MISLABELING DURING MANUFACTURING, A MIX-UP DURING REWORK, OR DUE TO A MIX-UP AT AN AFFILIATE, DISTRIBUTOR, OR THE ACCOUNT. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD (LHR) FOR THE LABEL ON THE POUCH (9122261) AND THE LABEL ON THE CHIPBOARD BOX (0022261) DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS (NCMRS) ASSOCIATED WITH EITHER LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THE LHR FOR THE 3.5 X 15 MM VOYAGER NC (9122261) NOTED THAT THIS LOT WAS MANUFACTURED AND PACKAGED IN (B)(4) IN DECEMBER 2009, WHEREAS THE LOT OF THE RETURNED 3.0 X 15 MM VOYAGER NC (0022261) WAS MANUFACTURED AND PACKAGED IN (B)(4) IN FEBRUARY 2010, MONTHS AFTER PRODUCTION OF THE OTHER VOYAGER NC LOT (9122261) WAS COMPLETED. THIS INFORMATION SUGGESTS THAT THE 2 UNITS INVOLVED IN THIS INCIDENT WERE NEVER IN MANUFACTURING OR PACKAGING AT THE SAME TIME. FURTHER REVIEW OF THE SHIPMENT RECORDS INDICATED THAT BOTH LOTS WERE SHIPPED TO THE DISTRIBUTOR. HOWEVER, ABBOTT DOES NOT HAVE SHIPMENT RECORDS FROM THE DISTRIBUTOR TO THE HOSPITAL. ALTHOUGH IT CANNOT BE CONFIRMED WHAT LOTS THE DISTRIBUTOR SENT TO THIS SPECIFIC HOSPITAL, IT IS POSSIBLE THAT THE HOSPITAL MAY HAVE RECEIVED BOTH LOTS. THERE IS NO INDICATION THAT THE MIX-UP OCCURRED DURING MANUFACTURING AND PACKAGING OF THE PRODUCTS AT ABBOTT VASCULAR. SINCE THERE WAS EVIDENCE OF A SECOND TAPE SEAL, IT IS POSSIBLE THAT THE 3.5 X 15 MM VOYAGER NC DEVICE WAS INADVERTENTLY PACKAGED IN A 3.0 X 15 MM VOYAGER NC CHIPBOARD BOX AT THE DISTRIBUTOR OR AT THE HOSPITAL, ALTHOUGH THIS CANNOT BE CONFIRMED. ALTHOUGH THE EXACT CAUSE FOR THE MISLABELING/MIX-UP CANNOT BE DETERMINED, THERE IS NO INDICATION OF A MANUFACTURING OR PRODUCT QUALITY DEFICIENCY. ALL PRODUCTS ARE SUBJECT TO A 100% INSPECTION BY MANUFACTURING. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER UNPACKAGING THE 3.0 X 15 MM VOYAGER NC (1011754-15/0022261), IT WAS FOUND THAT THE PRODUCT INSIDE WAS LABELED 3.5 X 15 MM (1011756-15/9122261), NOT CONSISTENT BETWEEN THE INSIDE AND OUTSIDE LABELING. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER NC CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA 0022261

    Patients

    Seq Age Sex Outcome Treatment
    1