BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TREK CORONARY DILATATION CATHETER

    MDR report key: 2646360 · Received July 9, 2012

    Report

    Report Number
    2024168-2012-04338
    Event Type
    Malfunction
    Date Received
    July 9, 2012
    Date of Event
    June 13, 2012
    Report Date
    June 15, 2012
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 ANALYSIS, WHICH CONFIRMED THE DIFFERENCE IN LABELING BETWEEN THE DEVICE AND ITS PACKAGING. A REVIEW OF THE LOT HISTORY RECORD WAS CONDUCTED AND FOUND NO NON-CONFORMING REPORTS FOR THIS LOT. ADDITIONALLY, THE REVIEW OF THE COMPLAINT HANDLING DATABASE FOUND NO OTHER INCIDENTS RELATED TO LABELING ISSUES FOR THIS LOT. ALTHOUGH A PRODUCT DEFICIENCY WAS IDENTIFIED, IT APPEARS TO BE AN ISOLATED INCIDENT. BASED ON THE RELATED RECORDS REVIEW, REVIEW OF THE ELHR FOR THIS LOT AND THE ACTUAL COMPLAINT RATE, THERE IS NO INDICATION THAT THE LARGER POPULATION OF PRODUCT IS AFFECTED BY THIS ISSUE. ADDITIONALLY, THERE IS NO EVIDENCE TO SUGGEST THAT THE PRODUCT DEFICIENCY AFFECTS INVENTORY OR DISTRIBUTED PRODUCT. THE PRODUCT WAS MANUFACTURED PER THE APPLICABLE MANUFACTURING PROCESS INSTRUCTIONS AND PRODUCT SPECIFICATIONS. NO FURTHER ACTION IS REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE 2.25 X 20 MM TREK BALLOON CATHETER WITH LOT NUMBER 1101361 WAS REMOVED FROM THE PACKAGING AND THE SEALED INNER POUCH AND INSERTED INTO THE PATIENT; HOWEVER, ON ANGIOGRAPHY THE DEVICE WAS OBSERVED TO BE LABELED WITH A 2.5X15 MM SIZE AND LOT NUMBER 1101261. THE BALLOON CATHETER WAS REMOVED FROM THE PATIENT WITHOUT ISSUE AND A NEW 2.25X20 MM TREK BALLOON CATHETER WAS USED TO COMPLETE THE PROCEDURE. THE INNER STERILE POUCH WAS ALSO NOTED TO BE LABELED WITH THE SAME AS THE CHIPBOARD BOX WITH 1012271-20 PART NUMBER AND LOT NUMBER 1101361. 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
    1 TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 1101361

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR