BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2091996 · Received May 18, 2011

    Report

    Report Number
    2024168-2011-03531
    Event Type
    Malfunction
    Date Received
    May 18, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 22, 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. GUIDE WIRE: RUNTHROUGH. GUIDE CATH: UG. THE CUSTOMER REPORTS THAT THE DEVICE WAS DISCARDED, ALTHOUGH RETURN OF THE BALLOON CATHETER MAY HAVE AIDED THE INVESTIGATION. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO: BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, HANDLING, LESION CALCIFICATION AND TORTUOSITY, INTERACTION WITH A PREVIOUSLY IMPLANTED STENT, INSUFFICIENT PREPARATION PRIOR TO USE OR FROM INTERACTIONS WITH OTHER DEVICES. HOWEVER, SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE AND THE CATHETER WAS INITIALLY PRESSURIZED ONCE WITHOUT INCIDENT, THIS INDICATES THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. THE LESION WAS ALSO CHARACTERIZED AS MODERATELY TORTUOUS, MODERATELY CALCIFIED AND 90% STENOSED, WHICH LIKELY CONTRIBUTED TO THE REPORTED DIFFICULTY. THE BALLOON MATERIAL LIKELY BECAME DAMAGED (SCRATCHED) FROM INTERACTIONS WITH OTHER DEVICES AND/OR THE TORTUOUS AND CALCIFIED LESION, SUCH THAT THE BALLOON RUPTURED DURING THE SECOND INFLATION. 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 THE RATED BURST PRESSURE AND BALLOON INTEGRITY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD (LHR) DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS (NCMRS) ASSOCIATED WITH THIS LOT AND ALL LOT RELEASE TESTING FOR BALLOON RUPTURES MET MANUFACTURING CRITERIA. BALLOON RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS AND IS NOT NECESSARILY AN INDICATION OF QUALITY DEFICIENCY. IN THIS INSTANCE, BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT, 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 PRE-DILATATION WITH THE MINI TREK BALLOON CATHETER IN THE DISTAL LEFT ANTERIOR DESCENDING ARTERY, THE BALLOON RUPTURED AT 9 ATMOSPHERES DURING THE SECOND INFLATION. THE PROCEDURE CONTINUED WITH ANOTHER TREK CATHETER. VESSEL AND LESION SITE WERE CHARACTERIZED AS BEING MODERATELY TORTUOUS AND CALCIFIED, CONCENTRIC, DE NOVO AND 90% STENOSED. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1012461

    Patients

    Seq Age Sex Outcome Treatment
    1