BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 2984414 · Received February 28, 2013

    Report

    Report Number
    2024168-2013-01192
    Event Type
    Malfunction
    Date Received
    February 28, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    K103110
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE PRODUCT WAS RETURNED AND CONFIRMED THE REPORTED HUB DETACHMENT. A REVIEW OF THE ELECTRONIC LOT HISTORY RECORD (ELHR) FOR THE REPORTED LOT REVEALED NO ASSOCIATED NONCONFORMING MATERIAL RECORDS, INDICATING ALL LOT RELEASE TESTING MET SPECIFICATIONS. A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED ONE OTHER INCIDENT OF HUB DETACHMENT. ALTHOUGH A PRODUCT DEFICIENCY HAS BEEN IDENTIFIED, ALL PREVIOUS DATA SUGGEST THAT THIS IS AN ISOLATED INCIDENT. BASED ON THE QUALITY SYSTEM RELATED RECORDS REVIEW, ELHR REVIEW, AND THE ACTUAL COMPLAINT PRODUCT, THERE IS NO INDICATION THAT A LARGER POPULATION OF PRODUCT IS AFFECTED BY THIS ISSUE. FURTHER INVESTIGATION AND CORRECTIVE/PREVENTIVE ACTIONS WILL BE PERFORMED AS APPROPRIATE PER LOCAL OPERATING PROCEDURES.

    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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER OPENING THE SEALED OUTER CHIPBOARD BOX, AND PRIOR TO UNPACKING A 1.50X12 MINI TREK RX BALLOON DILATATION CATHETER (BDC), THE HUB APPEARED TO BE BENT BACKWARDS INSIDE OF THE SEALED INNER POUCH. WHEN THE MINI TREK RX BDC WAS UNPACKED, WITHOUT ANY ATTEMPT TO STRAIGHTEN OR ALTER THE DEVICE, THE HUB SEPARATED FROM THE SHAFT. ANOTHER MINI TREK RX BDC WAS USED SUCCESSFULLY IN COMPLETING THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT WITH THE COMPLAINT DEVICE AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88643 MINI TREK CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX AV-TEMECULA-CT 20810G2

    Patients

    Seq Age Sex Outcome Treatment
    1