BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 1963035 · Received January 18, 2011

    Report

    Report Number
    2024168-2011-00369
    Event Type
    Malfunction
    Date Received
    January 18, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 24, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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: BMW U2, FIELDER XT. GUIDE CATH: BOSTON. RHV: ABBOTT. EVALUATION SUMMARY: EVALUATION OF THE RETURNED RX TREK BALLOON CATHETER FOUND BLOOD VISIBLE IN THE GUIDE WIRE LUMEN, AS WELL AS BLOOD AND CONTRAST VISIBLE IN THE INFLATION LUMEN AND THE LOOSELY-FOLDED BALLOON. THIS IS CONSISTENT WITH THE REPORTED USE OF THE DEVICE AND A LEAK OR BALLOON RUPTURE. A NEW INDEFLATOR WAS USED IN AN ATTEMPT TO PRESSURIZE THE BALLOON WHEN FLUID LEAKED OUT OF A PINHOLE LOCATED ALONG A CREASE IN THE BALLOON ABOVE THE DISTAL MARKER, CONFIRMING THE REPORTED RUPTURE. THE BALLOON DID NOT EXHIBIT ANY TRACES OF MECHANICAL DAMAGE (SCRATCHES), THEREFORE, IT WAS SENT TO THE SCANNING ELECTRON MICROSCOPY (SEM) LAB FOR FURTHER ANALYSIS. THE SEM ANALYSIS CONFIRMED THAT THE LEAK WAS AT A FOLD/CREASE IN THE BALLOON AND DETERMINED THAT THE BALLOON FAILURE MAY HAVE BEEN ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. REPORTEDLY, 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. HOWEVER, THE EXACT CAUSE FOR THE PINHOLE TEAR WITHIN A BALLOON FOLD CANNOT BE DETERMINED. BALLOON MATERIAL RUPTURES MAY BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING PROCESSING OF THE BALLOON MATERIAL, MATERIALS, INFLATION TECHNIQUE, INTERACTIONS WITH OTHER DEVICES, A PREVIOUSLY IMPLANTED STENT, LESION CALCIFICATION AND TORTUOSITY OR INSUFFICIENT PREPARATION PRIOR TO USE. BASED ON THE INFORMATION PROVIDED, THE LESION WAS MODERATELY TORTUOUS AND 90% STENOSED, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. A REVIEW OF THE FINISHED PRODUCT LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS ASSOCIATED WITH THIS LOT THAT COULD HAVE CONTRIBUTED TO THIS REPORT. IN THIS INSTANCE, BASED ON THE INFORMATION RECEIVED WITH THIS COMPLAINT, THE ANALYSIS OF THE RETURNED PRODUCT AND THE RESULTS OF THE SEM ANALYSIS, A DEFINITIVE CAUSE FOR THE REPORTED BALLOON RUPTURE ALONG THE FOLD CANNOT BE DETERMINED. MANUFACTURING WILL BE NOTIFIED OF THIS INCIDENT FOR FURTHER INVESTIGATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED AT 8 ATMOSPHERES WHILE PRE-DILATING A LESION IN THE RIGHT CORONARY ARTERY USING A TREK BALLOON CATHETER. THE TREK BALLOON CATHETER WAS THE SECOND TO BE USED DUE TO THE PHYSICIAN PREFERING A LARGER DIAMETER. A THIRD TREK BALLOON CATHETER AND XIENCE PRIME STENT DELIVERY SYSTEM WERE USED TO COMPLETE THE PROCEDURE. 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-CT 0071661

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR