BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY

    MDR report key: 10545253 · Received September 17, 2020

    Report

    Report Number
    2029046-2020-01285
    Event Type
    Injury
    Date Received
    September 17, 2020
    Date of Event
    August 4, 2020
    Report Date
    August 18, 2020
    Manufacturer
    BIOSENSE WEBSTER INC.
    Product Code
    DRF
    PMA / PMN Number
    P030031/S053
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A WOLFF-PARKINSON-WHITE RADIOFREQUENCY ABLATION PROCEDURE ON WHICH A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY WAS USED, AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. ON (B)(6) 2020, ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THAT THIS WAS AN ABBOT CASE IN WHICH A BWI WEBSTER CS CATHETER AND AN ACUNAV CATHETER WAS USED. NO BWI REPRESENTATIVE WAS PRESENT DURING THE CASE; THEREFORE, NO FURTHER INFORMATION REGARDING THE SPECIFIC PRODUCT CODES AND PROCEDURE IS AVAILABLE. THERE WAS NO INDICATION THAT A SOUNDSTAR CATHETER WAS USED. BASED ON THE INFORMATION PROVIDED, THE FOLLOWING CHANGES HAVE BEEN PROCESSED: D1. BRAND NAME CHANGED FROM THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER TO WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY D2A.COMMON DEVICE NAME CHANGED FROM SIMILAR DEVICE D132701, PMA # P030031/S053 TO CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING D2B. PROCODE CHANGED FROM LPB TO DRF D4. CATALOG CHANGED FROM UNK_SMART TOUCH BIDIRECTIONAL TO UNK_WEBSTER CS WITH AUTO ID D11. CONCOMITANT MED PRODUCTSADDED UNK_ACUNAV. CONSIDER THE CONCOMITANT UNK_SOUNDSTAR REMOVED FROM THIS SECTION. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. # (B)(4).

    Additional Manufacturer Narrative · 1

    INFORMATION RECEIVED INDICATES THAT THE DEVICE IS NOT AVAILABLE FOR RETURN, THEREFORE NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. #(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A WOLFF-PARKINSON-WHITE RADIOFREQUENCY ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. POST-PROCEDURE THE PATIENT WAS NOTICED TO HAVE LOW BLOOD PRESSURE, AND PERICARDIAL EFFUSION WAS DIAGNOSED VIA INTRACARDIAC ECHOCARDIOGRAM (ICE). PERICARDIOCENTESIS WAS PERFORMED TO DRAIN AN UNSPECIFIED AMOUNT OF FLUID FROM THE PERICARDIAL SPACE TO STABILIZE THE PATIENT. PATIENT¿S OUTCOME IS UNKNOWN. THERE¿S NO INDICATION THAT EXTENDED HOSPITALIZATION WAS REQUIRED. PHYSICIAN¿S CAUSALITY OPINION WAS NOT PROVIDED. NO BIOSENSE WEBSTER PRODUCT MALFUNCTIONS NOR ERROR MESSAGES WERE REPORTED. SPECIFIC PRODUCT INFORMATION IS NOT AVAILABLE. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE. SHOULD MORE INFORMATION BECOME AVAILABLE, IT WILL BE REVIEWED AND PROCESSED ACCORDINGLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1009605 WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R UNK_ACUNAV| UNK_SOUNDSTAR