BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 8204803 · Received December 28, 2018

    Report

    Report Number
    2029046-2018-02497
    Event Type
    Injury
    Date Received
    December 28, 2018
    Date of Event
    April 13, 2017
    Report Date
    December 2, 2018
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    UDI-DI
    10846835010183
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ON JANUARY 2, 2019, ADDITIONAL INFORMATION WAS RECEIVED ON THE EVENT. IT WAS ORIGINALLY REPORTED ON DECEMBER 28, 2018 THAT IT WAS THE PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO THE BIOSENSE WEBSTER, INC.PRODUCT. HOWEVER, PER THE ADDITIONAL INFORMATION RECEIVED, IT STATED THAT THE PRINCIPAL INVESTIGATOR ASSESSED THIS EVENT AS PROBABLY RELATED TO THE BIOSENSE WEBSTER, INC. PRODUCT. MANUFACTURER'S REFERENCE # (B)(4).

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS DISCARDED, THEREFORE NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED AND DEVICE MALFUNCTION CANNOT BE CONFIRMED.  DEVICE HISTORY RECORD (DHR) REVIEW 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 REFERENCE # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED TRANSIENT ISCHEMIC ATTACK (TIA) REQUIRING MEDICATION. POST-PROCEDURE, THE PATIENT DEVELOPED NEUROLOGICAL SYMPTOMS: NUMBNESS IN HANDS AND SWOLLEN HANDS. A MAGNETIC RESONANCE IMAGING (MRI) WAS PERFORMED TO DIAGNOSE A DISEASE OR INJURY, THE RESULTS WERE AS FOLLOWS: ¿LT. OCCIPUT AREA, PERIPHERAL CORTEX TINY SINGLE CHANGE¿. MEDICATION (PRADAXA 150 MG) WAS ADMINISTERED. EXTENDED HOSPITALIZATION WAS REQUIRED FOR NEUROLOGIC MONITORING. ON POST-PROCEDURE DAY 2, THE PATIENT WAS DISCHARGED AFTER IMPROVING SYMPTOM. PHYSICIAN¿S OPINION REGARDING THE CAUSE OF THE ADVERSE EVENT IS THAT IT WAS RELATED TO THE BIOSENSE WEBSTER, INC. PRODUCT. MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN CLARIFICATION TO THIS COMPLAINT. HOWEVER, NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1042071 THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC 10846835010183

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization