BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2963893 · Received February 15, 2013

    Report

    Report Number
    2024168-2013-00889
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 20, 2013
    Report Date
    January 21, 2013
    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. CONCOMITANT MEDICAL DEVICES: GUIDE WIRE: SION BLUE; GUIDE CATH: HEARTRAIL. (B)(4) - INCORRECT PREP. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES. REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. IT SHOULD BE NOTED THAT THE RX TREK INSTRUCTIONS FOR USE STATES: SUBMERGE THE BALLOON IN HEPARINIZED NORMAL SALINE DURING BALLOON PREPARATION TO ACTIVATE THE COATING. IF THE SURFACE OF THIS DEVICE BECOMES DRY, WETTING WITH HEPARINIZED NORMAL SALINE WILL REACTIVATE THE COATING. IF ANY RESISTANCE IS FELT DURING PREPARATION, DISCONTINUE THE USE OF THE BALLOON AND REPLACE IT WITH ANOTHER BALLOON. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS, HEAVILY CALCIFIED, CONCENTRIC, AND 99% STENOSED DISTAL CIRCUMFLEX ARTERY. A 2.0 X 15 MM RX MINI TREK BALLOON CATHETER WAS BEING USED FOR PRE-DILATATION WHEN IT RUPTURED AT 4 ATMOSPHERES ON THE THIRD INFLATION. A NC TREK BALLOON CATHETER WAS USED FOR FURTHER DILATATION AND A XIENCE PRIME STENT WAS IMPLANTED TO COMPLETE THE PROCEDURE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE AND NO ADVERSE PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    67216 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20718G6

    Patients

    Seq Age Sex Outcome Treatment
    1