BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINI TREK CORONARY DILATATION CATHETER

    MDR report key: 1955347 · Received January 10, 2011

    Report

    Report Number
    2024168-2011-00205
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 16, 2010
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LOX
    PMA / PMN Number
    P810046
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. ANALYSIS IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). BALLOON MATERIAL RUPTURES CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, BALLOON DAMAGE DURING MANUFACTURING, MATERIALS, HANDLING, LESION CALCIFICATION AND TORTUOSITY, AN INTERACTION WITH A PREVIOUSLY IMPLANTED STENT, INSUFFICIENT PREPARATION PRIOR TO USE OR FROM INTERACTIONS WITH OTHER DEVICES. SINCE THERE WAS NO REPORT OF ANY LEAKS NOTED DURING PREPARATION FOR USE, THIS MAY INDICATE THAT THE BALLOON WAS NOT DAMAGED PRIOR TO THE PROCEDURE. IF THE BALLOON EXPERIENCES MECHANICAL DAMAGE AT SOME POINT DURING THE PROCEDURE, THIS CAN CAUSE THE MATERIAL TO WEAKEN AND RUPTURE DURING AN ATTEMPT TO INFLATE THE CATHETER. NO PATIENT ANATOMICAL INFORMATION WAS PROVIDED, WHICH MAY HAVE AIDED THE INVESTIGATION. IN THIS CASE, RETURN OF THE MINI TREK MAY HAVE ULTIMATELY AIDED IN DETERMINING A CAUSE FOR THE EXPERIENCED RUPTURE. THE REPORTED PATIENT EFFECT OF EMBOLISM, AS LISTED IN THE PRODUCT INSTRUCTIONS FOR USE (IFU), IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH CORONARY ANGIOPLASTY PROCEDURES AND IS NOT NECESSARILY AN INDICATION OF A PRODUCT QUALITY DEFICIENCY. IN THIS INSTANCE, BASED ON THE LIMITED INFORMATION RECEIVED WITH THIS COMPLAINT AND WITHOUT THE PRODUCT TO EXAMINE, A DEFINITIVE CAUSE FOR THE REPORTED RUPTURE CANNOT BE DETERMINED. FURTHERMORE, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED. ALL DILATATION CATHETERS ARE 100% VISUALLY INSPECTED AND LEAK TESTED DURING THE MANUFACTURING PROCESS. A SAMPLING OF UNITS IS ALSO DESTRUCTIVELY TESTED TO VERIFY RATED BURST PRESSURE AND BALLOON INTEGRITY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON RUPTURED DURING USE, AND THE PATIENT EXPERIENCED AN AIR EMBOLUS. NO TREATMENT WAS REPORTED. THE PATIENT HAS RECOVERED FROM THE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other