BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER RX CORONARY DILATATION CATHETER

    MDR report key: 2063395 · Received April 19, 2011

    Report

    Report Number
    2024168-2011-02742
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 25, 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. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING PROCESSING OF THE BALLOON MATERIAL, MATERIALS, INFLATION TECHNIQUE, INTERACTIONS WITH OTHER DEVICES, A PREVIOUSLY IMPLANTED STENT, LESION CALCIFICATION AND TORTUOSITY OR INSUFFICIENT PREPARATION PRIOR TO USE. BASED ON THE INFORMATION PROVIDED, THE LESION WAS MILDLY CALCIFIED AND 90% STENOSED, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE BALLOON CATHETER WAS RETURNED WITH BLOOD AND CONTRAST VISIBLE IN THE INFLATION LUMEN AND THE LOOSELY-FOLDED BALLOON, WHICH IS CONSISTENT WITH THE REPORTED USE OF THE DEVICE AND A LEAK OR BALLOON RUPTURE. THE ANALYSIS CONFIRMED THAT THERE WAS A LONGITUDINAL RUPTURE IN THE BALLOON IN THE DISTAL TAPER, EXTENDING PROXIMALLY FOR A LENGTH OF 1.8 CM. SCANNING ELECTRON MICROSCOPY (SEM) CONFIRMED THAT THE RUPTURE INITIATED FROM THE INNER SURFACE OF THE BALLOON. THIS TYPE OF RUPTURE IS MOST CONSISTENT WITH EXPOSURE CONDITIONS DURING THE PROCEDURE, A MATERIAL/PROCESSING DISCREPANCY, MULTIPLE INFLATIONS AND/OR HIGH STRESS BEING APPLIED TO THE BALLOON MATERIAL. SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE AND THE CATHETER WAS INITIALLY PRESSURIZED TWICE WITHOUT INCIDENT, THIS INDICATES THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. IT IS POSSIBLE THAT AN INTERACTION WITH THE CALCIFIED LESION IN ADDITION TO INFLATING THE BALLOON MULTIPLE TIMES TO RATED BURST PRESSURE (RBP) LIKELY CONTRIBUTED TO THE EXPERIENCED RUPTURE. 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. FURTHERMORE, A QUERY OF THE COMPLAINT-HANDLING DATABASE DID NOT REVEAL ANY OTHER INCIDENTS REPORTED FROM THIS LOT, SUGGESTING THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. BASED ON THE INFORMATION RECEIVED WITH THIS EVENT, THE ANALYSIS OF THE RETURNED PRODUCT AND THE RESULTS OF THE SEM ANALYSIS, THE REPORTED BALLOON RUPTURE APPEARS TO BE RELATED TO OPERATION CONTEXT OF THE DEVICE AND NOT A PRODUCT QUALITY DEFICIENCY. PRODUCT PERFORMANCE ENGINEERING WILL MONITOR THE INCIDENT CIRCUMSTANCES. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RBP AND BALLOON INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS THE PROXIMAL LEFT CIRCUMFLEX WITH NO TORTUOSITY, MILD CALCIFICATION AND 90% STENOSIS. PRE-DILATATION WAS PERFORMED WITH THE VOYAGER RX 2.75 X 15 MM BALLOON, BUT IT RUPTURED AT 14 ATMOSPHERES DURING THE THIRD INFLATION. A NEW VOYAGER RX 2.75 X 15 MM BALLOON WAS USED FOR PRE-DILATATION AND A PROMUS 2.75 X 18 MM STENT WAS USED TO COMPLETE THE PROCEDURE. 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 0080261

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: ROUTE