BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 3100652 · Received May 8, 2013

    Report

    Report Number
    2024168-2013-02884
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 14, 2013
    Report Date
    April 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Adverse Event
    Yes
    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. 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 AND THE REPORTED RUPTURE WAS CONFIRMED. BASED ON VISUAL, FUNCTIONAL AND SCANNING ELECTRON MICROSCOPY ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. 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. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. HYPOTENSION IS LISTED AS A KNOWN PATIENT EFFECT IN THE RX TREK INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED; THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A 75% STENOSED LESION IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH MILD TORTUOSITY AND MILD CALCIFICATION. THIS IS AN ACUTE MYOCARDIAL INFARCTION PATIENT. THROMBUS ASPIRATION WAS PERFORMED IN THE OSTIUM OF THE LAD AND BLOOD FLOW WAS IMPROVED. THE 3.0 X 15 MM TREK BALLOON CATHETER WAS PREPARED PER THE INSTRUCTIONS FOR USE AND ADVANCED WITHOUT ISSUE FOR PRE-DILATATION. DURING THE FIRST INFLATION OF 6 ATMOSPHERES (ATM), FOR 30 SECONDS, THE BALLOON RUPTURED. AT THIS POINT, THE PATIENT HEMODYNAMICS BECAME WORSE DUE TO THE BALLOON RUPTURE; THEREFORE, AN INTRA-AORTIC BALLOON PUMP (IABP) WAS INSERTED. A NON-ABBOTT BALLOON CATHETER WAS THEN ATTEMPTED, BUT ALSO RUPTURED. A NON-ABBOTT STENT WAS THEN IMPLANTED. THE PATIENTS HEMODYNAMICS RECOVERED; HOWEVER, THE IABP REMAINS IN THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201974 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20911G2

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention GUIDE WIRE: BMW ELITE, GUIDE CATH: LAUNCHER JL4