BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTARAY NAV

    MDR report key: 20208814 · Received September 12, 2024

    Report

    Report Number
    2029046-2024-03064
    Event Type
    Injury
    Date Received
    September 12, 2024
    Date of Event
    August 16, 2024
    Report Date
    January 31, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012224
    PMA / PMN Number
    K123837
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ON (B)(6) 2024, ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE PATIENT HAD A THROMBOSIS IN THE BRAIN DUE TO A BLOOD CLOT. NO CLOT WAS SEEN ON THE CATHETER. THE THERMOCOOL SMARTTOUCH DID NOT ENTER THE BODY. 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 · 0

    THE DEVICE INVESTIGATION HAS BEEN COMPLETED WHICH INCLUDED PERFORMING A MANUFACTURING RECORD EVALUATION (MRE). THE MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31334850L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. ADDITIONALLY, THE MANUFACTURED DATE HAS BEEN PROVIDED. THEREFORE, FIELD H4. DEVICE MANUFACTURE DATE HAS BEEN POPULATED. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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 · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION AND THE PATIENT EXPERIENCED CEREBRAL OCCLUSION / THROMBOSIS THAT REQUIRED THROMBOLYSIS. DEVICE INVESTIGATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J) FOR EVALUATION. A VISUAL INSPECTION AND REVISION OF ALL FEATURES WERE PERFORMED FOLLOWING J&J PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE DEVICE FEATURES WERE REVIEWED, AND NO ISSUES WERE OBSERVED DURING THE PRODUCT INVESTIGATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31334850L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. NO MALFUNCTION WAS OBSERVED DURING THE PRODUCT ANALYSIS. OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THE PHYSICIAN'S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS PATIENT CONDITION. THE INSTRUCTION FOR USE (IFU) CONTAINS THE FOLLOWING WARNINGS AND PRECAUTIONS: CAREFUL MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. CATHETER ADVANCEMENT AND PLACEMENT THROUGH A GUIDING SHEATH SHOULD BE DONE USING A COMBINATION OF VISUAL AIDS AVAILABLE, FLUOROSCOPIC GUIDANCE AND/OR INTRACARDIAC ULTRASOUND. IN ADDITION, EXTRA CARE SHOULD BE TAKEN WHILE INSERTING, ASPIRATING, AND MANIPULATING THE GUIDING SHEATH. PRIOR TO REMOVING OR REPOSITIONING THE CATHETER, USE DIRECT IMAGING GUIDANCE SUCH AS FLUOROSCOPY OR ULTRASOUND TO CONFIRM THAT THE SPINE ASSEMBLY IS NOT ENTANGLED WITH ANOTHER CATHETER OR WITH AN ANATOMICAL STRUCTURE. EXERCISE CAUTION WHEN MANEUVERING THE CATHETER NEAR THE VALVULAR APPARATUS TO AVOID ENTANGLEMENT OR ENTRAPMENT WHICH MAY RESULT IN THE NEED FOR SURGICAL INTERVENTION. AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PREMATURE VENTRICULAR CONTRACTION (PVC) ABLATION AND THE PATIENT EXPERIENCED CEREBRAL OCCLUSION / THROMBOSIS THAT REQUIRED THROMBOLYSIS. PATIENT HAD A CEREBRAL OCCLUSION AND UNDERWENT A CEREBRAL ANGIOGRAPHY. THE SPECIFIC SIZE OF THE CLOT WAS NOT MENTIONED; HOWEVER, THE PHYSICIAN (NEUROLOGIST) STATED THAT IT WAS A TINY OCCLUSION. DURING A PVC PROCEDURE WITH PENTARAY IN THE LEFT VENTRICLE, IN A PATIENT WITH ISCHEMIC HEART, THE DOCTOR NOTICED IRREGULAR BEHAVIOR IN THE PATIENT AND STOPPED THE PROCEDURE. THE STAFF WENT TO THE EMERGENCY ROOM DUE TO A POSSIBLE CLOT AFTER THE TEST AND A THROMBOLYSIS, AND "THE PATIENT WAS OUT OF DANGER". THERE WAS NO ISSUE RELATED TO TEMPERATURE AND FLOW ON THE CATHETER. NO ABLATION WAS PERFORMED. THERE WAS NO THERAPEUTIC CATHETER INSIDE THE PATIENT. THE PATIENT WAS ANTICOAGULATED, IN THIS CASE ACTIVATED CLOTTING TIME (ACT) CONTROL WAS NOT USED. HEPARINIZED NORMAL SALINE WAS USED. THE PHYSICIAN'S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS PATIENT CONDITION. THE PATIENT HAS FULLY RECOVERED. WITH THE CURRENT INFORMATION AVAILABLE, IT IS NOT CLEAR IF THERE WAS CHAR OR THROMBUS ON THE CATHETER ITSELF. FOLLOW UP HAS BEEN REQUESTED TO CLARIFY. ADDITIONALLY, THE ADVERSE EVENT IS BEING CAPTURED ON THE PENTARAY MAPPING CATHETER AS THE INFORMATION RECEIVED STATED THAT THERE WAS NO THERAPEUTIC CATHETER INSIDE THE PATIENT AND ABLATION WAS NOT PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1535704 PENTARAY NAV CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31334850L 10846835012224

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention| L SMARTABLATE IRR TUBE SET.| SMARTABLATE IRRIGATION PUMP WW.| SMARTABLATE RF GENERATOR WW.| THMCL SMTCH SF UNID, TC, D.