BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOGARTY

    MDR report key: 20794215 · Received November 27, 2024

    Report

    Report Number
    2015691-2024-09016
    Event Type
    Malfunction
    Date Received
    November 27, 2024
    Date of Event
    August 28, 2024
    Report Date
    November 27, 2024
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    DXE
    UDI-DI
    00690103043457
    PMA / PMN Number
    K240078
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A PRODUCT EVALUATION WAS COMPLETED ON THE RETURNED 12TLW403F. THE REPORTED EVENT OF BALLOON RUPTURED WAS CONFIRMED. AS RECEIVED, BALLOON WAS FOUND TO BE RUPTURED IN THE CENTRAL AREA. BALLOON EDGES DID NOT MATCH AT THE RUPTURED REGION. RUPTURE PART WAS NOT RETURNED. PER THE IFU "BALLOON RUPTURE AND CATHETER SEPARATION AS A RESULT OF EXCESSIVE PULL FORCE APPLIED TO REMOVE ADHERENT MATERIAL ARE THE MOST FREQUENT CAUSES OF REPORTED FAILURES." AND "TO MINIMIZE THE RISK OF VESSEL DAMAGE, BALLOON RUPTURE, OR TIP DETACHMENT, DO NOT EXCEED THE MAXIMUM RECOMMENDED INFLATION AND PULL FORCE FOR EACH SIZE CATHETER". BOTH BALLOON WINDINGS WERE INTACT. NO OTHER VISIBLE DAMAGE WAS OBSERVED FROM THE CATHETER. THROUGH LUMEN WAS PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. AS PART OF THE MANUFACTURING PROCESS, A 100% OF THE UNITS GO THROUGH BALLOON AND WINDING INSPECTION PROCESS. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE THAT SUPPORTS OR CONFIRMS THE FAILURE MODE IS ASSOCIATED TO A MANUFACTURING/DESIGN DEFECT. ADDITIONAL PRODUCT CODE: KRA; ADDITIONAL 510K: K892410.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BALLOON OF THIS FOGARTY CATHETER RUPTURED DURING USE. PATIENT DEMOGRAPHICS WERE REQUESTED BUT UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849573 FOGARTY CATHETER, EMBOLECTOMY DXE EDWARDS LIFESCIENCES PR 12TLW403F 65432258 00690103043457

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown