BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THERMOCOOL SMART TOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER

    MDR report key: 11817513 · Received May 13, 2021

    Report

    Report Number
    2029046-2021-00759
    Event Type
    Injury
    Date Received
    May 13, 2021
    Date of Event
    April 16, 2021
    Report Date
    April 16, 2021
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    LPB
    PMA / PMN Number
    P030031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON(B)(6) /2021 STATING THAT NO ABLATION CATHETER WAS OPENED AT THE TIME OF THIS OCCURRENCE. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2021 UPDATING THE PRODUCT OF UNK_SMART TOUCH BIDIRECTIONAL SF TO THMCL SMTCH SF UNID, TC, F / D-1347-02-S. THEREFORE, UPDATED THE FIELDS OF D1. BRAND NAME, D4. CATALOG, D4. UNIQUE IDENTIFIER( UDI) AND G4. PMA/ 510(K). IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4) DURING AN INTERNAL REVIEW, A CORRECTION WAS NOTED ON 7/11/2021 TO THE 3500A INITIAL REPORT TO THE "H5. LABELED FOR SINGLE USE?" FIELD AS IT WAS LEFT BLANK. THEREFORE, UPDATED THIS FIELD ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    INITIALLY IT WAS REPORTED THAT THE ¿DEVICE EVALUATION WAS ANTICIPATED, BUT NOT YET BEGUN¿. ADDITIONAL INFORMATION WAS RECEIVED ON 30-JUN-2021 STATING THAT THE PRODUCT IS NOT AVAILABLE FOR RETURN. ADDITIONAL 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 REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 1

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. BIOSENSE WEBSTER MANUFACTURER'S REFERENCE NUMBER (B)(4) HAS TWO COMPLAINTS THAT ARE RELATED TO THE SAME INCIDENT. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A (B)(6) MALE PATIENT UNDERWENT A LEFT SIDED ISCHEMIC VENTRICULAR TACHYCARDIA (ISVT ¿ LEFT) WITH A CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - LARGE AND A THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER AND SUFFERED A CARDIAC TAMPONADE REQUIRING PERICARDIOCENTESIS. IN ADDITION, A HEMOSTATIC VALVE SEPARATION OCCURRED ON THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - LARGE. DURING THE PROCEDURE, THE HEMOSTATIC VALVE AT THE HUB OF THE SHEATH WAS LEAKING BLOOD. IT IS UNKNOWN WHICH PART OF THE SHEATH BROKE. PATIENT¿S HEMODYNAMICS WAS NOT COMPROMISED DUE TO THE ISSUE EXPERIENCED. NO INTERVENTIONS WERE REQUIRED TO STOP THE BLEEDING. IT WAS NOT KNOWN IF AIR ENTERED THE PATIENT¿S BODY. THE SHEATH WAS REPLACED, AND THE PROCEDURE WAS CONTINUED. IT WAS ALSO REPORTED THE PATIENT DEVELOPED A DELAYED PERICARDIAL EFFUSION POST-PROCEDURE. THE PATIENT, WHILE IN RECOVERY HAD CHEST PAIN AND THEIR BLOOD PRESSURE DROPPED. AN ECHOCARDIOGRAM WAS PERFORMED AND SHOWED THE PATIENT HAD PERICARDIAL EFFUSION. THE PATIENT WENT BACK TO THE LAB AND HAD A PERICARDIOCENTESIS. THERE WAS 470ML OF FLUID REMOVED FROM THE PATIENT. THE PATIENT WAS STABLE THE ENTIRE TIME. THE PHYSICIAN BELIEVED THE ISSUE WAS DUE TO THE SHEATH EXCHANGE THAT WAS REQUIRED FOR THE VALVE MALFUNCTION OF THE SHEATH. THE PATIENT IS STABLE AND HAD FULLY RECOVERED. THE PATIENT STAYED OVERNIGHT FOR OBSERVATION. TRANSSEPTAL NEEDLE WAS DONE WITH A BAYLIS TRANSSEPTAL NEEDLE. THERE WAS NO EVIDENCE OF STEAM POP NOR OTHER PRODUCT MALFUNCTION DURING THE ABLATION. THIS EVENT WAS REVIEWED AND IT WAS ASSESSED TO CONSERVATIVELY REPORT UNDER BOTH, THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH - LARGE AND THE THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER SINCE THE ADVERSE EVENT WAS DISCOVERED AFTER ABLATION HAD BEEN ALREADY APPLIED. GIVEN THE ABLATION CATHETER INFORMATION IS UNKNOWN AT THE TIME, AN IMPACTED PRODUCT FOR A GENERIC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER WAS CREATED. SHOULD MORE INFORMATION BECOME AVAILABLE, IT WILL BE REVIEWED AND PROCESSED ACCORDINGLY. SINCE THIS EVENT IS LIFE THREATENING AND REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE; WAS TO BE CONSIDERED SERIOUS AND MDR REPORTABLE. THE HEMOSTATIC VALVE ISSUE WAS ASSESSED AS A MDR REPORTABLE HEMOSTATIC VALVE SEPARATION ISSUE UNDER THE CARTO VIZIGO¿ 8.5F BI-DIRECTIONAL GUIDING SHEATH ¿ LARGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719166 THERMOCOOL SMART TOUCH SF UNI-DIRECTIONAL NAVIGATION CATHETER CARDIAC ABLATION PERCUTANEOUS CATHETER LPB BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Life Threatening| R 8.5F SHEATH WITH CURVE VIZ LGC| NON BWI - BAYLIS TRANSSEPTAL NEEDLE| UNKNOWN BRAND SHEATH