BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 2550524 · Received April 26, 2012

    Report

    Report Number
    2024168-2012-02693
    Event Type
    Malfunction
    Date Received
    April 26, 2012
    Date of Event
    April 2, 2012
    Report Date
    April 3, 2012
    Manufacturer
    AV-TEMECULA-CT
    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). EVALUATION SUMMARY: BASED ON VISUAL AND SCANNING ELECTRON MICROSCOPY (SEM) IMAGING ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES. SEM ANALYSIS WAS PERFORMED AND THE RESULTS SUGGEST THAT THE BALLOON FAILURE MAY POSSIBLY BE RELATED TO A MATERIALS/PROCESSING DISCREPANCY OR EXPOSURE CONDITIONS. TEARING WAS DOCUMENTED INITIATING FROM THE INNER DIAMETER (ID) SURFACE AT THE RUPTURE ORIGIN. PARTIAL TEARS WERE ALSO FOUND AT, NEAR AND AWAY FROM THE RUPTURE EDGE ON THE ID SURFACE. NO SIGNIFICANT FEATURES WERE OBSERVED ON THE OUTER SURFACE OF THE BALLOON. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT SHOULD BE NOTED THAT THE RX VOYAGER INSTRUCTION FOR USE STATES: SUBMERGE THE BALLOON IN STERILE HEPARINIZED NORMAL SALINE DURING BALLOON PREPARATION TO ACTIVATE THE COATING.

    Additional Manufacturer Narrative · 1

    (B)(4): TO NOT PRE-SOAKING THE BALLOON AND INCORRECT PREPARATION. DEVICE WAS RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION, A VOYAGER RX BALLOON WAS NOT PRE-SOAKED PRIOR TO USE. DURING THE PRE-DILATATION OF THE NON-CALCIFIED LESION OF A MILDLY TORTUOUS RIGHT POSTERIOR DESCENDING ARTERY PROCEDURE, THE VOYAGER RX BALLOON RUPTURED ON THE FIRST INFLATION AT 14 ATMOSPHERES. THE VOYAGER RX BALLOON WAS REMOVED AND A NEW VOYAGER RX BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE DILATION. THERE WAS NO ADVERSE PATIENT EFFECT OR SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER RX CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0082061

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: ROUTE