BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2240253 · Received September 9, 2011

    Report

    Report Number
    2024168-2011-06220
    Event Type
    Malfunction
    Date Received
    September 9, 2011
    Date of Event
    August 15, 2011
    Report Date
    August 15, 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. PHYSICAL RESISTANCE WHEN ATTEMPTING TO CROSS A LESION CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PATIENT ANATOMICAL MORPHOLOGY, PATIENT DISEASE STATE, PRE-DILATATION STRATEGY, PRODUCT PLACEMENT TECHNIQUE, PRODUCT SIZE SELECTION AND ACCESSORY PRODUCT SUPPORT; AND IS TYPICALLY NOT ASSOCIATED WITH A PRODUCT QUALITY DEFICIENCY. IN THIS CASE, IT WAS REPORTED THE LESION WAS HEAVILY CALCIFIED, WHICH MAY HAVE CONTRIBUTED TO THE RESISTANCE. AS THE CATHETER WAS EVENTUALLY ABLE TO CROSS THE LESION, THE REPORTED PHYSICAL RESISTANCE APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PRODUCT. FACTORS THAT CAN CONTRIBUTE TO BALLOON RUPTURE INCLUDE, BUT ARE NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, WEAK MATERIALS, EXCESSIVELY APPLIED PRESSURE, OR INTERACTIONS WITH ACCESSORY DEVICES, PATIENT ANATOMY, AND/OR LESION CALCIFICATION OR TORTUOSITY. RETURN OF THE RX MINI TREK CATHETER USED IN THE PROCEDURE MAY HAVE AIDED IN THE INVESTIGATION AND DETERMINATION OF CAUSE. THERE WAS NO REPORT OF ANY LEAK IN THE CATHETER NOTED DURING PREPARATION FOR USE, WHICH WOULD SUGGEST THAT THE BALLOON WAS NOT DAMAGED PRIOR TO USE. IT IS POSSIBLE THAT THE BALLOON MATERIAL WAS DAMAGED (SCRATCHED) DURING INTERACTIONS WITH ACCESSORY DEVICES, OR THE HEAVILY CALCIFIED LESION SUCH THAT THE BALLOON RUPTURED UPON THE SECOND INFLATION AT 12 ATMOSPHERE. A REVIEW OF THE DEVICE LOT HISTORY RECORD DID NOT REVEAL ANY NONCONFORMING MATERIAL RECORDS FOR THIS LOT, AND ALL LOT RELEASE TESTING MET MANUFACTURING CRITERIA. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE IS NO INDICATION OF A LOT SPECIFIC DEFICIENCY. A CONCLUSIVE CAUSE COULD NOT BE DETERMINED FOR THE RUPTURE. ALL BALLOON CATHETERS ARE VISUALLY INSPECTED AND LEAK TESTED PRIOR TO PACKAGING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE OF THE ECCENTRIC, HEAVILY CALCIFIED, 99% STENOSED, DE NOVO, MID LEFT ANTERIOR DESCENDING ARTERY LESION, SOME RESISTANCE WAS MET DURING ADVANCING IN THE ANATOMY, HOWEVER, THE 1.2 MM X 6 MM TREK WAS INFLATED AND DURING THE SECOND INFLATION AT 12 ATMOSPHERE (ATM) FOR 10 SECONDS THE BALLOON RUPTURED. THE FIRST INFLATION WAS AT 10 ATM FOR 10 SECONDS. THERE WAS NO REPORT OF A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE DEVICE ISSUE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. A NON-ABBOTT BALLOON WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. THOUGH REQUESTED, 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 1022161

    Patients

    Seq Age Sex Outcome Treatment
    1