BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 3021732 · Received March 26, 2013

    Report

    Report Number
    2024168-2013-01733
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 27, 2013
    Report Date
    March 1, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED IRREGULAR APPEARANCE WAS CONFIRMED. THE REPORTED DIFFICULTY TO POSITION AND DIFFICULTY TO REMOVE COULD NOT BE CONFIRMED. BASED ON ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES FOR THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY. IT SHOULD BE NOTED THAT THE MINI TREK INSTRUCTIONS FOR USE STATES THAT IF RESISTANCE IS FELT, DETERMINE THE CAUSE BEFORE PROCEEDING. CONTINUING TO ADVANCE OR RETRACT THE CATHETER WHILE UNDER RESISTANCE MAY RESULT IN DAMAGE TO THE VESSELS AND / OR DAMAGE / SEPARATION OF THE CATHETER. IN THIS CASE, THE FORCE APPLIED APPEARS TO BE RELATED TO THE CIRCUMSTANCE OF THE PROCEDURE SUCH THAT THE PHYSICIAN WAS PLACED IN THE POSITION TO USE FORCE TO REMOVE THE CATHETER.

    Additional Manufacturer Narrative · 1

    (B)(4). GUIDE WIRE: HT BALANCE MIDDLEWEIGHT, PILOT; GUIDE CATH: MEDTRONIC LAUNCHER 6F JR. THE DEVICE HAS BEEN RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) WITH MILD TORTUOSITY AND 90% STENOSIS. A 6 FRENCH NON-ABBOTT GUIDING CATHETER WAS USED VIA FEMORAL ACCESS. THE 2.0 X 15 MM MINI TREK BALLOON WAS ADVANCED, HOWEVER RESISTANCE WAS ENCOUNTERED WITH THE GUIDING CATHETER DURING ADVANCEMENT AND THE BALLOON COULD NOT EXIT THE GUIDING CATHETER. IT WAS DECIDED TO RETRACT THE MINI TREK BALLOON. DURING RETRACTION, RESISTANCE WAS ENCOUNTERED WITH THE ROTATING HEMOSTATIC VALVE (RHV) AND FORCE HAD TO BE APPLIED TO RETRACT IT THROUGH THE RHV. AFTER RETRACTION OF THE BALLOON, IT WAS NOTICED THAT THE SHAFT AREA APPEARED IRREGULAR. IT WAS REPLACED WITH ANOTHER DEVICE TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY OF PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123420 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 21121G2

    Patients

    Seq Age Sex Outcome Treatment
    1 CONCOMITANT MEDICAL DEVICES