BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 2152696 · Received July 7, 2011

    Report

    Report Number
    2024168-2011-04812
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 15, 2011
    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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. GUIDE WIRE: SION BLUE. GUIDE CATH: AUTOBAHN 6 F. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, HANDLING, LESION CALCIFICATION AND TORTUOSITY, AN INTERACTION WITH A PREVIOUSLY IMPLANTED STENT, INSUFFICIENT PREPARATION PRIOR TO USE OR FROM INTERACTIONS WITH OTHER DEVICES. IN THIS CASE, THE LESION WAS CHARACTERIZED AS MILDLY TORTUOUS, MILDLY CALCIFIED AND 90% STENOSED, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. IT IS POSSIBLE THAT THE BALLOON MATERIAL BECAME DAMAGED (SCRATCHED) FROM INTERACTIONS WITH OTHER DEVICES AND/OR THE TORTUOUS AND CALCIFIED LESION, SUCH THAT THE BALLOON RUPTURED UPON INFLATION ATTEMPT. RETURN OF THE VOYAGER MAY HAVE ULTIMATELY AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE EXPERIENCED RUPTURE. TO ENSURE THIS TYPE OF DAMAGE IS NOT A RESULT OF A POTENTIAL PRODUCT RELATED DEFICIENCY, ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE AND BALLOON INTEGRITY. IN THIS CASE, ALTHOUGH THERE WAS NO REPORT OF ANY LEAKS NOTED DURING DEVICE PREPARATION, ADDITIONAL INFORMATION RECEIVED FROM THE ACCOUNT STATED THAT THE DEVICE WAS PREPPED INSIDE THE BODY. IT SHOULD BE NOTED THE RX TREK INSTRUCTIONS FOR USE CAUTIONS: ALL AIR MUST BE REMOVED FROM THE BALLOON AND DISPLACED WITH CONTRAST PRIOR TO INSERTING INTO THE BODY. THERE IS A POSSIBILITY OF COMPLICATION, DEVICE IMPROPERNESS OR ADVERSE EFFECTS IF AIR IS LEFT IN THE BALLOON. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. THERE DOES NOT APPEAR TO BE ANY INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. BASED ON THE INFORMATION RECEIVED WITH THIS INCIDENT AND WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED BALLOON RUPTURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS IN THE DISTAL RIGHT CORONARY ARTERY (RCA) WITH MILD TORTUOSITY, MILD CALCIFICATION AND 90% STENOSIS. THE DEVICE WAS PREPARED INSIDE OF PATIENT ANATOMY. THE BALLOON WOULD NOT INFLATE AND AFTER WITHDRAWAL FROM THE ANATOMY IT WAS CONFIRMED THAT THE BALLOON WAS RUPTURED. NO RESISTANCE WAS REPORTED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS 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 0030261

    Patients

    Seq Age Sex Outcome Treatment
    1