BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2182641 · Received July 28, 2011

    Report

    Report Number
    2024168-2011-05351
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    July 5, 2011
    Report Date
    July 5, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    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 WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). KINKS OR BENDS IN THE SHAFT CAN LEAD TO WEAKENING OF THE CATHETER MATERIAL SUCH THAT A SUBSEQUENT APPLICATION OF FORCE OR FURTHER HANDLING CAN CAUSE A SEPARATION. IN THIS CASE, IT WAS REPORTED THAT THE TREK CATHETER WAS USED SUCCESSFULLY MULTIPLE TIMES IN THE PATIENT ANATOMY WITHOUT ANY ISSUE AND THERE WERE NO KINKS OR DAMAGE NOTED TO THE CATHETER DURING THE INSPECTION PRIOR TO USE WHICH SUGGESTS A PRODUCT DEFICIENCY DID NOT CONTRIBUTE TO THE REPORTED DIFFICULTY. IT IS LIKELY THAT THE SHAFT OF THE CATHETER WAS INADVERTENTLY HANDLED DURING THE PROCEDURE, RESULTING THE IN THE SHAFT KINKING. FURTHER MANIPULATION OF THE SHAFT OUTSIDE OF THE PATIENT ANATOMY WOULD HAVE CONTRIBUTED TO THE SHAFT ULTIMATELY SEPARATING. 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. ADDITIONALLY, A QUERY OF THE COMPLAINT-HANDLING DATABASE WAS PERFORMED AND THERE HAS BEEN NO OTHER INCIDENTS REPORTED FOR THIS LOT. THERE IS NO INDICATION OF A LOT SPECIFIC PRODUCT QUALITY DEFICIENCY. THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE AND THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY. ALL DILATATION CATHETERS ARE VISUALLY INSPECTED FOR KINKS DURING MANUFACTURING. ADDITIONALLY, A SAMPLING OF UNITS IS DESTRUCTIVELY TESTED TO VERIFY LUMEN INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE RIGHT CORONARY ARTERY, THE TREK BALLOON WAS SUCCESSFULLY USED FOR MULTIPLE INFLATIONS/DEFLATIONS UNDER 12 ATMOSPHERE WHEN THE DEVICE WAS REMOVED FROM THE ANATOMY WITHOUT ISSUE. THE DEVICE WAS TO BE USED A SECOND TIME IN THE ANATOMY AND DURING DEVICE PREPARATION AND SOAK IN HEPARINED SALINE, NEGATIVE WAS PULLED WITH THE INDEFLATOR AND IT WAS NOTED THAT THE HUB AT THE HYPOTUBE HAD DETACHED. THE DEVICE WAS NOT USED A SECOND TIME IN THE ANATOMY. THERE WAS NO REPORTED ISSUE OF INFLATION OR DEFLATION DURING THE FIRST USAGE OF THE DEVICE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE DEVICE ISSUE. A SECOND TREK BALLOON WAS PREPARED AND USED IN THE PROCEDURE WITHOUT INCIDENT. 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 1041561

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR