BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 1914508 · Received December 3, 2010

    Report

    Report Number
    2024168-2010-02592
    Event Type
    Malfunction
    Date Received
    December 3, 2010
    Date of Event
    November 8, 2010
    Report Date
    November 9, 2010
    Manufacturer
    AV-TEMECULA
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE INABILITY TO INFLATE THE CATHETER MAY BE RELATED TO NUMEROUS FACTORS INCLUDING, BUT IS NOT LIMITED TO, PATIENT ANATOMICAL/LESION MORPHOLOGY AND PATIENT DISEASE STATE, MANUFACTURING, LEAKS, DAMAGE TO THE BALLOON OR INFLATION LUMEN, INFLATION LUMEN OBSTRUCTION, CONTRAST CONCENTRATION, INFLATION TECHNIQUE, OR FROM AN INTERACTION WITH ACCESSORY DEVICES (INDEFLATOR, RHV, OR GC). ADDITIONALLY, LEAKS/TEARS IN THE BALLOON CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT IS 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. RETURN OF THE TREK CATHETER MAY HAVE AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE EXPERIENCED DIFFICULTIES. HOWEVER, SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, THIS MAY SUGGEST THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. IT IS POSSIBLE THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED/TORN) FROM INTERACTIONS WITH OTHER DEVICES AND/OR THE PATIENT ANATOMY SUCH THAT THE BALLOON FAILED TO INFLATE IN AN ATTEMPT TO PRESSURIZE THE CATHETER, ALTHOUGH THIS CANNOT BE CONFIRMED. NO PATIENT ANATOMICAL INFORMATION WAS PROVIDED WHICH MAY HAVE FURTHER AIDED THE INVESTIGATION. BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT AND WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED FAILURE TO INFLATE THE CATHETER AND A HOLE/TEAR IN THE BALLOON CANNOT BE DETERMINED. 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 PRODUCT QUALITY, INCLUDING FUNCTIONAL TESTING FOR BALLOON INFLATION/DEFLATION AND RATED BURST PRESSURE TO VERIFY BALLOON INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE DEVICE WAS PLACED IN AN UNKNOWN VESSEL AND THE OPERATOR ATTEMPTED THE FIRST TIME TO INFLATE THE BALLOON; HOWEVER, IT WOULD NOT INFLATE. THE DEVICE WAS REMOVED FROM THE PATIENT WITH NO ILL EFFECTS REPORTED. THE OPERATOR LOOKED AT THE BALLOON AND REPORTED THAT HE COULD SEE A HOLE. NO PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1