BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1900679 · Received November 16, 2010

    Report

    Report Number
    2024168-2010-02454
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    September 30, 2010
    Report Date
    October 1, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: ANALYSIS OF THE RETURNED PRODUCT NOTED NO BLOOD OR CONTRAST VISIBLE. THE BALLOON HAD RELAXED FOLDS. THERE WAS A KINK IN THE DISTAL SHAFT 1MM PROXIMAL TO THE PROXIMAL BALLOON SEAL. THE INNER MEMBER WAS COLLAPSED 7 MM PROXIMAL TO THE PROXIMAL BALLOON SEAL FOR A LENGTH OF 1.6 CM. AN ATTEMPT WAS MADE TO BACK LOAD A MANDREL TO MEASURE THE INNER MEMBER OF THE GUIDE WIRE LUMEN; HOWEVER, THE MANDREL COULD NOT ADVANCE 1 MM PAST THE SOFT TIP. THE MANDREL WAS THEN ADVANCED THROUGH THE GUIDE WIRE EXIT NOTCH AND A SMALL PIECE OF A NON-ABBOTT GUIDE WIRE WAS PUSHED OUT OF THE TIP. THE PIECE OF GUIDE WIRE WAS A HYPOTUBE 2.6 CM IN LENGTH, WITH THE CORE SEPARATED AT BOTH ENDS. THERE WERE MULTIPLE KINKS IN THE HYPOTUBE. AFTER REMOVING THE PIECE OF GUIDE WIRE, THE MANDREL WAS BACK LOADED AND FRONT LOADED WITH RESISTANCE FELT WHERE THE INNER MEMBER WAS COLLAPSED. A NEW GUIDE WIRE WAS BACK LOADED THROUGH THE CATHETER WITH NO RESISTANCE NOTED. IT IS POSSIBLE THAT THE NON-ABBOTT GUIDE WIRE WAS KINKED AND DAMAGED, AS EVIDENT IN THE RETURNED PORTION, WHICH WOULD HAVE CONTRIBUTED TO THE REPORTED RESISTANCE. FURTHER HANDLING AND MANIPULATION AS RESISTANCE WAS ENCOUNTERED WOULD HAVE CONTRIBUTED TO THE NON-ABBOTT GUIDE WIRE SEPARATING. IT IS POSSIBLE THAT THE INNER MEMBER WAS WEAKENED FROM MOVEMENT OF THE CATHETER AGAINST RESISTANCE, FURTHER CONTRIBUTING TO THE DIFFICULTIES ADVANCING THE GUIDE WIRE. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO ADVANCE THE BALLOON CATHETER OVER THE GUIDE WIRE AND CAUSE RESISTANCE BETWEEN THE DEVICES MAY INCLUDE, BUT IS NOT LIMITED TO, DEVICE PLACEMENT TECHNIQUE, GUIDING CATHETER SUPPORT, INNER DIAMETER OF GUIDE WIRE LUMEN, OUTER DIAMETER OF THE GUIDE WIRE, CONDITION OF THE GUIDE WIRE, BUILD UP OF BLOOD OR CONTRAST, OR DAMAGE TO THE CATHETER. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED DIFFICULTY ADVANCING THE BALLOON CATHETER OVER THE GUIDE WIRE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED ONLINE FOR DAMAGE. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND CHECKED FOR PROPER GUIDE WIRE MOVEMENT ON THE MANUFACTURING LINE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE PREPARATION/INSERTION THE VOYAGER BALLOON CATHETER COULD NOT BE ADVANCED ON THE GUIDE WIRE. THERE WAS NO REPORTED PATIENT EFFECT. NO ADDITIONAL INFORMATION WAS PROVIDED. DEVICE ANALYSIS REVEALED A PORTION OF A NON-ABBOTT GUIDEWIRE STUCK IN THE BALLOON TIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA 0062462

    Patients

    Seq Age Sex Outcome Treatment
    1