BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 1935940 · Received December 22, 2010

    Report

    Report Number
    2024168-2010-02856
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 30, 2010
    Report Date
    November 30, 2010
    Manufacturer
    AV-CLONMEL
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. 2.0 X 12 MM RX VOYAGER (1011392-12/0032362), 1.5 X 15 MM TAZUNA, 2.0 X 15 TAZUNA; GUIDE WIRE: SION BLUE(SJM) STENT: XIENCE. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. THE 2.0 X 12 MM RX VOYAGER ((B)(4)), IS BEING FILED UNDER A SEPARATE MFR#.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED RX VOYAGER NOTED CONTRAST VISIBLE IN THE INFLATION LUMEN AND THE BALLOON WAS LOOSELY FOLDED, WHICH IS CONSISTENT WITH PREPARATION AND THE BALLOON INFLATED. A NEW INDEFLATOR WAS USED TO PRESSURIZE THE BALLOON TO THE RATED BURST PRESSURE (RBP) OF 14 ATMOSPHERES. THE BALLOON INFLATED WITH NO ANOMALIES NOTED. IN THIS CASE, THE REPORTED RUPTURE COULD NOT BE CONFIRMED AND THERE WAS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. 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 BALLOON RUPTURE COULD NOT BE CONFIRMED. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 1.5 X 15 MM VOYAGER RX BALLOON RUPTURED. THE LESION WAS THEN DILATED WITH A NON-ABBOTT BALLOON CATHETER. A 2.0 X 12 VOYAGER RX WAS USED IN AN ATTEMPT TO PREDILATE FURTHER; HOWEVER, THIS BALLOON ALSO RUPTURED UPON INFLATION. THE LESION WAS FURTHER DILATED WITH A NON-ABBOTT BALLOON CATHETER, AND A XIENCE V STENT WAS IMPLANTED. NO ADDITIONAL INFORMATION OR PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-CLONMEL 9051441

    Patients

    Seq Age Sex Outcome Treatment
    1