BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOYAGER NC CORONARY DILATATION CATHETER

    MDR report key: 2213048 · Received August 16, 2011

    Report

    Report Number
    2024168-2011-05765
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 21, 2011
    Report Date
    July 22, 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: FIELDER FC. GUIDE CATH: RADIGUIDE 6 F JR 3.5. STENT: S-STENT 3.5 X 14. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURES INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, WEAK MATERIALS, EXCESSIVELY APPLIED PRESSURE, OR INTERACTIONS WITH ACCESSORY DEVICES, PATIENT ANATOMY, AND/OR LESION CALCIFICATION OR TORTUOSITY. RETURN OF THE VOYAGER NC CATHETER USED IN THE PROCEDURE MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE. THERE WAS NO REPORT OF ANY LEAK IN THE CATHETER NOTED DURING PREPARATION FOR USE, WHICH WOULD SUGGEST THAT THE BALLOON WAS NOT DAMAGED PRIOR TO USE. IT IS POSSIBLE THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH THE HEAVILY CALCIFIED LESION OR THE IMPLANTED STENT SUCH THAT THE BALLOON RUPTURED UPON THE FIRST INFLATION AT 16ATM WHICH IS BELOW THE RATED BURST PRESSURE (RBP). TO ENSURE THIS IS NOT A RESULT OF MANUFACTURING, ALL BALLOON CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RBP. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THE COMPLAINT AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAVE BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. BASED ON THE INFORMATION RECEIVED WITH THIS INCIDENT, THE REPORTED BALLOON RUPTURES 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 THE TARGET LESION WAS IN THE MID RIGHT CORONARY ARTERY, WITH A VESSEL DIAMETER OF 3.5 MM, AND A LESION LENGTH OF 11 MM. THE VESSEL HAD MILD TORTUOSITY, HEAVY CALCIFICATION, WAS CONCENTRIC, DE NOVO, WITH A 90% STENOSIS. THE PATIENT WAS EXPERIENCING AN ACUTE MYOCARDIAL INFARCTION. PREDILATATION WAS PERFORMED WITH A NON-ABBOTT BALLOON AND A NON-ABBOTT STENT WAS DEPLOYED; HOWEVER, THE STENT WAS NOT WELL EXPANDED. THE 3.5 X 8 MM VOYAGER NC WAS USED FOR POSTDILATATION; HOWEVER, THE BALLOON RUPTURED ON THE FIRST INFLATION OF 16 ATMOSPHERES, FOR 15 SECONDS. THERE WAS NO RESISTANCE NOTED DURING ADVANCEMENT OR RETRACTION OF THE BALLOON DURING USE. A NON-ABBOTT BALLOON 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 NC CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1030162

    Patients

    Seq Age Sex Outcome Treatment
    1