BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2972596 · Received February 21, 2013

    Report

    Report Number
    2024168-2013-01017
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 29, 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. (B)(4) - INCORRECT PREP. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED DEFLATION ISSUE COULD NOT BE CONFIRMED. THE REPORTED DIFFICULTY TO REMOVE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. 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 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 TREK INSTRUCTIONS FOR USE, STATES TO EVACUATE AIR FROM THE BALLOON SEGMENT. IN THIS CASE, THE EVACUATION OF AIR FROM THE DEVICE IS IN THE PREPARATION FOR USE SECTION WHICH IS SEQUENTIALLY PRIOR TO INSERTION IN TO THE PATIENT. THIS PROCESS DURING PREPARATION OF THE DEVICE WOULD IDENTIFY ANY LEAK WITH THIS THE BALLOON CATHETER DURING NEGATIVE PRESSURE WITH THE SYRINGE. IN THIS, CASE, THERE WAS NO REPORTED LEAK OR NOTED DURING THE RETURNED DEVICE ANALYSIS. THEREFORE, THE PREPARATION INSIDE THE ANATOMY DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED DEFLATION ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A PATIENT EXPERIENCING AN ACUTE MYOCARDIAL INFARCTION. THE LESION WAS LOCATED IN THE 75% STENOSED DISTAL RIGHT CORONARY ARTERY. AFTER THROMBUS SUCTION WAS PERFORMED, A 2.5 X 20 MM NON-ABBOTT BALLOON CATHETER WAS USED FOR PREDILATATION, AFTER WHICH THE 3.0 X 20 MM TREK BALLOON WAS ALSO USED FOR PREDILATATION. AFTER THREE INFLATIONS OF THE 3.0 X 20 MM TREK BALLOON AT 14 ATMOSPHERES EACH INFLATION, THE FIRST DEFLATION OF THE BALLOON WAS NORMAL; HOWEVER, THE SECOND AND THIRD DEFLATIONS WERE SLOWER THAN USUAL. THE THIRD DEFLATION TOOK MORE THAN 30 SECONDS; HOWEVER, THE BALLOON WAS EVENTUALLY ABLE TO BE DEFLATED FULLY. DIFFICULTY WAS FELT RETRACTING THE CATHETER FROM THE PATIENT; HOWEVER, THE BALLOON CATHETER WAS ABLE TO BE RETRACTED SUCCESSFULLY FROM THE PATIENT. TWO XIENCE PRIME STENTS WERE ABLE TO BE DEPLOYED SUCCESSFULLY TO COMPLETE THE CASE. NO ADVERSE PATIENT EFFECTS, OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75980 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20621G1

    Patients

    Seq Age Sex Outcome Treatment
    1