BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 4141260 · Received October 3, 2014

    Report

    Report Number
    2024168-2014-06442
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 10, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE REPORTED SHAFT SEPARATION WAS CONFIRMED. THE REPORTED DEFLATION ISSUE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS THE RETURNED DEVICE WAS NOT RETURNED IN A CONDITION IN WHICH THE TEST COULD BE PERFORMED. BASED ON THE VISUAL ANALYSIS OF THE DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE COMPLAINT HANDLING DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. THE REPORTED PATIENT EFFECT OF ANGINA, AS LISTED IN THE TREK RX INSTRUCTIONS FOR USE (IFU) IS A KNOWN PATIENT EFFECT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    SUBSEQUENT INFORMATION RECEIVED NOTED THAT WHEN THE CINE WAS REVIEWED AT THE FACILITY WITH THE ABBOTT REPRESENTATIVE THE CONTRAST APPEARED DARK ON ANGIOGRAM ALTHOUGH THE MIXTURE WAS NOTED AS 50 NAC1/50 CONTRAST. THE PATIENT WAS DISCHARGED ON (B)(6) 2014 WITHOUT REPORTED ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SUBJECT PRESENTED WITH UNSTABLE ANGINA AND ANGIOGRAPHY REVEALED INSTENT RESTENOSIS OF THE STENT IN THE FIRST DIAGONAL BRANCH OF THE BYPASS GRAFT. THE 3.5 X 25 MM TREK BALLOON DILATATION CATHETER (BDC) WAS INFLATED FOR 30 SECONDS UP TO 14 BAR, HOWEVER, THE BALLOON COULD NOT BE DEFLATED. SEVERAL UNSUCCESSFUL ATTEMPTS WERE MADE TO DEFLATE THE BALLOON AND IT REMAINED INFLATED FOR MORE THAN 2 MINUTES IN THE CORONARY BYPASS; THE PATIENT DEVELOPED STRONG ANGINA SYMPTOMS, HOWEVER, THE SUBJECTS CARDIOVASCULAR SYSTEM WAS STABLE. USING CONTROLLED FORCE THE INFLATED BALLOON AND GUIDE WIRE WERE RETRACTED FROM THE VESSEL INTO THE AORTA. MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO DEFLATE THE BALLOON OR PUNCTURE THE BALLOON USING THE GUIDE WIRE BLUNT END AND INFLATION UP TO 28 BAR. AGAIN, USING CONTROLLED FORCE THE INFLATED BALLOON WAS RETRACTED TO ABOUT 5 MM OF THE 6 FR SHEATH, HOWEVER, THE BALLOON BECAME SEPARATED FROM THE SHAFT. A LEFT FEMORAL ARTERY PUNCTURE AND CROSS-OVER APPROACH USING A 8 FR SHEATH WAS PERFORMED AND USING A SNARE THE BALLOON FRAGMENT WAS RETRIEVED. THE FRAGMENT BECAME STUCK AT THE EXIT OF THE COMMON FEMORAL ARTERY (CFA); ABOUT 1.0 CM WITHIN THE VESSEL AND 1.5 MM OUTSIDE THE VESSEL. A VASCULAR SURGEON WAS SUCCESSFUL IN RETRIEVING AND REMOVING THE BALLOON FRAGMENT FROM THE ANATOMY. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619798 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 30123G1

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention STENT:3.0 X 38 MM DRUG ELUTING STENT (DES)