BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 1723683 · Received June 9, 2010

    Report

    Report Number
    2024168-2010-01134
    Event Type
    Malfunction
    Date Received
    June 9, 2010
    Date of Event
    May 7, 2010
    Report Date
    May 18, 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
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: THE HUB OF THE RETURNED DEVICE WAS LABELED AS A 3.5 X 20 MM VOYAGER NC WITH LOT NUMBER 9072861. THE BALLOON WAS PRESSURIZED TO NOMINAL PRESSURE (12 ATM) TO MEASURE THE OUTER DIAMETER OF THE BALLOON, CONFIRMING THAT THE CATHETER WAS IN FACT A 3.5 MM DEVICE AND NOT 3.0 MM AS INDICATED ON THE RETURNED CHIPBOARD BOX WHICH WAS LABELED 3.0 X 20 MM VOYAGER NC WITH PART NUMBER 1011754-20 AND LOT NUMBER 0010561. THIS CONFIRMS THE REPORTED ISSUE AS THE LABELING ON THE CATHETER HUB DOES NOT CORRESPOND WITH THE LABELING AFFIXED TO THE CHIPBOARD BOX. FURTHER INSPECTION OF THE RETURNED BOX NOTED EVIDENCE OF ONLY ONE PIECE OF TAPE THAT HAD BEEN ORIGINALLY ATTACHED TO THE BOX. THE TYVEK POUCH WAS NOT RETURNED, WHICH MAY HAVE AIDED THE EVAL. ADD'L INFO RECEIVED FROM THE ACCOUNT REPORTED THAT THE LOT NUMBER PRINTED ON THE POUCH LABELING WAS 0010561, WHICH MATCHES THE CHIPBOARD BOX LABELING. IT WAS REPORTED THAT THE USER FACILITY TECH CHECK EVERY DEVICE BEFORE USE AND THE CHIPBOARD BOX WAS SECURED SHUT WITH A PIECE OF TAPE PRIOR TO OPENING THE BOX TO USE THE PRODUCT AT THE TIME OF THE PROCEDURE. REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD (LHR) FOR BOTH THE RETURNED CATHETER (9072861) AND THE RETURNED CHIPBOARD BOX (0010561) DID NOT REVEAL ANY NON CONFORMING MATERIAL RECORDS (NCMR) ASSOCIATED WITH EITHER LOT AND ALL LOT RELEASE TESTING MET MFG CRITERIA. A QUERY OF THE COMPLAINT-HANDLING DATABASE DID NOT REVEAL ANY OTHER INCIDENTS WITH EITHER LOT, SUGGESTING THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. THE LHR FOR THE 3.5 X 20 MM VOYAGER NC (9072861) NOTED THAT THIS LOT WAS MANUFACTURED IN JULY 2007, WHEREAS THE LOT OF THE RETURNED CHIPBOARD BOX (0010561) WAS MANUFACTURED IN JANUARY 2010. THERE WERE 2 UNITS FROM THE RETURNED CATHETER LOT (9072861) THAT WERE REWORKED BY THE MFG SITE IN OCTOBER 2009, THREE MONTHS BEFORE LOT 0010561 WAS PRODUCED. SHIPMENT RECORDS FROM THE DISTRIBUTOR TO THE HOSPITAL WERE NOT AVAILABLE. ALTHOUGH IT CANNOT BE CONFIRMED WHAT LOTS THE DISTRIBUTOR SENT TO THIS SPECIFIC HOSPITAL, IT IS POSSIBLE THAT THE HOSP MAY HAVE RECEIVED BOTH LOTS. FACTORS THAT CAN POTENTIALLY CONTRIBUTE TO A MISLABELING DISCREPANCY MAY INCLUDE, BUT ARE NOT LIMITED TO, MISLABELING DURING MFG, OR DUE TO A MIX-UP AT AN AFFILIATE, DISTRIBUTOR OR THE ACCOUNT. OVERALL, BASED ON THE INFO RECEIVED WITH THIS COMPLAINT AND THE ANALYSIS OF THE RETURNED PRODUCT, A DEFINITIVE CAUSE FOR THE REPORTED MISLABELING/MIX-UP CANNOT BE DETERMINED. ALL PRODUCTS ARE SUBJECT TO A 100% INSPECTION BY MFG. IN ADDITION, A QUALITY CONTROL AUDIT INSPECTION IS PERFORMED TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    DEVICE ISSUE: MISLABELED. TIME OF DEVICE ISSUE: DURING USE. ADVERSE EVENT: NONE. IT WAS REPORTED THAT THE OUTER PACKAGING OF THE VOYAGER NC INDICATED IT WAS A 3.0 X 20MM; HOWEVER, THE HUB OF THE DEVICE WAS LABELED AS 3.5 X 20 MM. REPORTEDLY, THERE WERE NO PATIENT EFFECTS. NO ADD'L EVENT OR PATIENT INFO 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 0010561

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK DILATATION CATHETER: VOYAGER 2.5 X 20 MM