BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2113702 · Received June 3, 2011

    Report

    Report Number
    2024168-2011-03876
    Event Type
    Malfunction
    Date Received
    June 3, 2011
    Date of Event
    May 11, 2011
    Report Date
    May 11, 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 NS, SION BLUE. GUIDE CATH: HEARTRAIL 6F JL4. STENT: XIENCE V 3.5 X 18 MM. BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT 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. IN THIS CASE, SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, THIS MAY INDICATE THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. ADDITIONALLY, THE LESION WAS MILDLY CALCIFIED AND THE MINI TREK WAS USED TO POST DILATE A STENT, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. IT IS POSSIBLE THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) FROM INTERACTIONS WITH OTHER DEVICES AND/OR THE CALCIFIED LESION, SUCH THE BALLOON RUPTURED UPON THE SECOND INFLATION AT 12 ATMOSPHERES WHICH IS BELOW THE RATED BURST PRESSURE. ULTIMATELY, RETURN OF THE MINI TREK MAY HAVE AIDED THE INVESTIGATION IN DETERMINING A CAUSE FOR THE EXPERIENCED RUPTURE. 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. IN THIS CASE, WITHOUT THE PRODUCT TO EXAMINE, A CONCLUSIVE CAUSE FOR THE REPORTED RUPTURE COULD NOT BE DETERMINED. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY RBP AND BALLOON INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH NO TORTUOSITY, MILD CALCIFICATION AND 90% STENOSIS. A 2.0 X 12 MM MINI TREK WAS USED FOR POST-DILATATION OF A XIENCE V 3.5 X 18 MM; HOWEVER, THE BALLOON RUPTURED DURING THE SECOND INFLATION AT 12 ATMOSPHERES. THE PHYSICIAN COMMENTED THAT HE IS NOT SURE IF THE BALLOON RUPTURE WAS CAUSED BY THE INTERACTION BETWEEN THE BALLOON AND THE STENT STRUTS OR BY THE TREK ITSELF. IT WAS CONFIRMED WITH INTRA-VASCULAR ULTRA SOUND (IVUS) THAT THERE WAS NO ISSUE WITH THE XIENCE STENT. THERE WAS NO ADVERSE PATIENT EFFECTS 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 1011862

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR