BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ PACING TD CATHETER

    MDR report key: 18258966 · Received December 4, 2023

    Report

    Report Number
    2015691-2023-17901
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    November 13, 2023
    Report Date
    August 12, 2024
    Manufacturer
    EDWARDS LIFESCIENCES PR
    Product Code
    LDF
    UDI-DI
    00690103197334
    PMA / PMN Number
    K791183
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    UDI RELATED DATA QUALITY UPDATES ONLY THE UDI NUMBER IS: (B)(4). THE FOLLOWING IS CORRECTED DATA, AS THE ORIGINAL IDENTIFICATION INFORMATION SENT DID NOT MATCH THE DATA SUBMITTED TO THE GLOBAL UNIQUE DEVICE IDENTIFICATION DATABASE (GUDID): D1 BRAND NAME: SWAN-GANZ PACING TD CATHETER D2A COMMON DEVICE NAME: ELECTRODE, PACEMAKER, TEMPORARY D2B DEVICE PRODUCT CODE: LDF

    Additional Manufacturer Narrative · 0

    OUR PRODUCT EVALUATION LAB RECEIVED ONE MODEL D205F7 PACING CATHETER. THE CUSTOMER REPORT OF PACING ISSUE WAS CONFIRMED. NO OTHER VISIBLE DAMAGE OR INCONSISTENCY WAS OBSERVED FROM CATHETER BODY, SYRINGE, CONNECTORS AND BALLOON. ALL THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. THE BALLOON INFLATED CLEAR AND CONCENTRIC AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. CONTINUITY TESTING FOUND THAT THERE WAS AN OPEN CONDITION IN THE VENTRICULAR DISTAL CIRCUIT (#1) AND IN THE ATRIAL DISTAL CIRCUIT (#3) RESPECTIVELY. THE REST OF THE CIRCUITS (#2, 4, 5) WERE CONTINUOUS WITHOUT SHORT CONDITIONS. FURTHER EXAMINATION CONFIRMED THAT THE VENTRICULAR DISTAL LEADWIRE WAS BROKEN/DETACHED AROUND ELECTRODE #1 AND THAT THE ATRIAL DISTAL LEADWIRE WAS BROKEN/DETACHED AROUND ELECTRODE #3. IT WAS ALSO CONFIRMED THAT THE VENTRICULAR DISTAL CIRCUIT (#1) WAS CONTINUOUS FROM THE BROKEN LEAD WIRE TO VENTRICULAR DISTAL PIN AND THAT THE ATRIAL DISTAL CIRCUIT (#3) WAS CONTINUOUS FROM THE BROKEN LEAD WIRE TO ATRIAL DISTAL PIN. AN ENGINEERING EVALUATION WAS PREFORMED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT, A MANUFACTURING ROOT CAUSE COULD NOT BE CONFIRMED. THE IFU CONTAINS A PRECAUTION: AVOID FORCEFUL WIPING OR STRETCHING OF THE CATHETER DURING TESTING AND CLEANING AS NOT TO BREAK THE ELECTRODE OR THERMISTOR WIRE CIRCUITRY. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.

    Additional Manufacturer Narrative · 0

    THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER, THE COMPLAINT CANNOT BE CONFIRMED WITHOUT THE COMPLETION OF A PRODUCT EVALUATION. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WITH THE EVALUATION AND DEVICE HISTORY RESULTS WHEN RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT IT WAS UNABLE TO PACE DURING USE. THE FOLLOWING INFORMATION WAS UNAVAILABLE: BACKGROUND OF MALFUNCTION OCCURRENCE, THE PHASE WHEN THE CATHETER GOT UNABLE TO PACE, WHAT KIND OF SURGERY/EXAMINATION THE CATHETER WAS USED FOR, WHETHER THE PATIENT HAD CARDIAC CONDUCTION DEFECT OR WHETHER THE CATHETER WAS REPLACED. PATIENT DEMOGRAPHIC INFORMATION WAS REQUESTED BUT UNAVAILABLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2178568 SWAN-GANZ PACING TD CATHETER ELECTRODE, PACEMAKER, TEMPORARY LDF EDWARDS LIFESCIENCES PR D205F7 65155988 00690103197334
    2333892 SWAN-GANZ PACING TD CATHETER ELECTRODE, PACEMAKER, TEMPORARY LDF EDWARDS LIFESCIENCES PR D205F7 65155988 00690103197334

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown