BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2152451 · Received July 7, 2011

    Report

    Report Number
    2024168-2011-04800
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    June 14, 2011
    Report Date
    June 15, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    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. 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. 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 RATED BURST PRESSURE (RBP). RETURN OF THE RX TREK 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 LIKELY THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH THE MILDLY CALCIFIED LESION, SUCH THAT THE BALLOON RUPTURED UPON THE FIFTH INFLATION AT 10-14 ATMOSPHERES (ATM) WHICH IS BELOW THE RBP. A REVIEW OF THE PRODUCT MANUFACTURING RECORDS DID NOT REVEAL ANY NON-CONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT 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 BALLOON RUPTURES FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. IN THIS INSTANCE, ALTHOUGH THE DEVICE WAS NOT RETURNED FOR ANALYSIS, BASED ON THE INFORMATION RECEIVED WITH THIS INCIDENT, THE REPORTED 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 MID LEFT ANTERIOR DESCENDING ARTERY STENTING PROCEDURE, DURING PRE-DILATATION OF THE MILDLY CALCIFIED 99% STENOSED LESION, DURING THE FIFTH INFLATION AT 10-14 ATMOSPHERES (ATM) FOR 20 SECONDS, THE BALLOON RUPTURED. THE VESSEL WAS WELL DILATED, SO A XIENCE V STENT WAS SUCCESSFULLY DEPLOYED AT THE LESION AND THE LESION WAS POST-DILATATED. THERE WAS NO ADVERSE PATIENT SEQUELA REPORTED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 0082662

    Patients

    Seq Age Sex Outcome Treatment
    1 GUIDE WIRE: SION BLUE, XT-RGUIDE CATH: TAIGA EBU