BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER OTW CORONARY DILATATION CATHETER

    MDR report key: 2183156 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05377
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    June 14, 2011
    Report Date
    July 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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 NC VOYAGER MENTIONED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. PHYSICAL RESISTANCE DURING ADVANCEMENT CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, DEVICE SIZE SELECTION, DAMAGE TO THE CATHETER, AND INTERACTIONS WITH OTHER DEVICES OR ACCESSORY DEVICE SUPPORT. THE LESION WAS CHARACTERIZED AS HEAVILY CALCIFIED AND LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTY. FURTHERMORE, 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. ALTHOUGH RETURN OF THE VOYAGER MAY HAVE FURTHER AIDED THE INVESTIGATION, THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, WHICH MAY INDICATE THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. ADDITIONALLY, SINCE IT WAS NOTED THAT ANOTHER BALLOON RUPTURED DURING THE PROCEDURE, THIS SUGGESTS THAT THE DIFFICULTIES EXPERIENCED WERE LIKELY RELATED TO THE HEAVILY CALCIFIED LESION. IN THIS CASE, THE BALLOON MATERIAL LIKELY BECAME DAMAGED (SCRATCHED) FROM INTERACTIONS WITH OTHER DEVICES AND/OR THE CALCIFIED LESION AS RESISTANCE WAS ENCOUNTERED, SUCH THAT THE BALLOON RUPTURED UPON INFLATION ATTEMPT. 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. 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 INCIDENT, THE REPORTED PHYSICAL RESISTANCE/DIFFICULTY CROSSING AND BALLOON RUPTURE APPEARS TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE AND NOT A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A HEAVILY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY INTERVENTION, RESISTANCE WAS FELT DURING ADVANCEMENT AND DURING LESION DILATATION, THE OTW VOYAGER, RUPTURED AT 8 ATMOSPHERES (ATM). THE DEVICE WAS REMOVED WITHOUT ISSUE. AN NC VOYAGER, MET RESISTANCE WHILE ADVANCING, WAS TAKEN TO THE LESION AND RUPTURED AT 8 ATM. SINCE THE LESION WAS SO HEAVILY CALCIFIED, IT WAS DECIDED TO STOP THE PROCEDURE AND TREAT MEDICALLY. THE PATIENT MAY BE BROUGHT BACK SOMETIME IN THE FUTURE TO HAVE AN ATHERECTOMY. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE. ALTHOUGH REQUESTED THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VOYAGER OTW CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0051861

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR