BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2031972 · Received March 28, 2011

    Report

    Report Number
    2024168-2011-02076
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 3, 2011
    Report Date
    March 3, 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: RINATO, ROUTE; GUIDE CATH: 6F HEARTTRAIL JR3.5SH. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE CATHETER WAS RETURNED WITH BLOOD VISIBLE IN THE HUB, THE INFLATION LUMEN AND IN THE LOOSELY-FOLDED BALLOON, WHICH IS CONSISTENT WITH THE REPORTED USE OF THE DEVICE AND A LEAK OR RUPTURE IN THE BALLOON. A NEW INDEFLATOR WAS USED IN AN ATTEMPT TO PRESSURIZE THE CATHETER WHEN FLUID LEAKED FROM A PINHOLE IN THE BALLOON ABOVE THE DISTAL MARKER, CONFIRMING THE REPORTED RUPTURE. THERE WERE SCRATCHES EVIDENT ON THE OUTER SURFACE OF THE BALLOON AT BOTH ENDS OF THE LEAK. THE BALLOON WAS ULTIMATELY SENT TO THE SCANNING ELECTRON MICROSCOPY (SEM) SHOWED THE BALLOON FAILURE MAY HAVE BEEN ATTRIBUTED TO MECHANICAL DAMAGE TO THE OUTER SURFACE. THE LEAK WAS CONFIRMED TO BE LOCATED ABOVE THE DISTAL MARKER ALONG A BALLOON FOLD/CREASE WITH MECHANICAL DAMAGE ADJACENT TO THE LEAK. THE DISTAL BALLOON MARKER ALSO EXHIBITED A RIDGE IN THE MATERIAL. THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, WHICH MAY INDICATE THAT THE RUPTURE WAS NOT PRESENT PRIOR TO THE PROCEDURE. HOWEVER, IT IS POSSIBLE THAT THE BALLOON AND MARKER WERE DAMAGED/PINCHED DURING MANUFACTURING SUCH THAT UPON INFLATION ATTEMPT, THE BALLOON RUPTURED AS A RESULT OF THE DAMAGE, THOUGH THIS CANNOT BE CONFIRMED. REPORTEDLY, THE LESION WAS MILDLY TORTUOUS, MILDLY CALCIFIED AND 75% 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 AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. A QUERY OF THE COMPLAINT-HANDLING DATABASE DID NOT REVEAL ANY OTHER INCIDENTS REPORTED FROM THIS LOT, SUGGESTING THAT THERE ARE NO LOT SPECIFIC PRODUCT QUALITY DEFICIENCIES. A DEFINITIVE CAUSE FOR THE REPORTED BALLOON RUPTURE ALONG THE FOLD AND DAMAGE NOTED CANNOT BE DETERMINED. BALLOON MATERIAL RUPTURE 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. ALL DILATATION CATHETERS ARE VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE AND BALLOON INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE CIRCUMFLEX WITH MILD TORTUOSITY, MILD CALCIFICATION, 75% STENOSIS THE 2.5 X 15 MM TREK BALLOON CATHETER WAS ADVANCED AND USED FOR PRE-DILATATION; HOWEVER, DURING THE FIRST INFLATION AT 8 ATMOSPHERE (ATM) THE BALLOON RUPTURED. AFTER REMOVAL FROM THE ANATOMY A PINHOLE WAS OBSERVED IN THE BALLOON. A NON-ABBOTT BALLOON WAS USED IN THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THOUGH REQUESTED, 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 0090963

    Patients

    Seq Age Sex Outcome Treatment
    1