BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER

    MDR report key: 13285831 · Received January 18, 2022

    Report

    Report Number
    2029046-2022-00110
    Event Type
    Injury
    Date Received
    January 18, 2022
    Date of Event
    December 22, 2021
    Report Date
    March 9, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012255
    PMA / PMN Number
    K123837
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL REPORTER PHONE: (B)(6). THE PRODUCT HAS NOT RETURNED FOR ANALYSIS, HOWEVER, A PICTURE WAS PROVIDED BY THE CUSTOMER. EVALUATION IS STILL IN PROGRESS. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6)-2022. THE PATIENT IS A 71-YEAR-OLD MALE. THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT IT WAS PROCEDURE RELATED. NO TREATMENT WAS CONDUCTED FOR THE HEART BLOCK. THE PATIENT OUTCOME OF THE ADVERSE EVENT WAS IMPROVED AND NO RESIDUAL EFFECTS. IT WAS NOT REPORTED THAT A RING, ELECTRODE OR ANY OTHER PHYSICAL DAMAGE OBSERVED AT THE DISTAL END OF THE CATHETER. THEREFORE, UPDATED SECTION A. PATIENT INFORMATION. THE INVESTIGATION WAS COMPLETED ON (B)(6)-2022. IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER BECAME STUCK IN THE TRICUSPID VALVE WHICH CAUSED HEART BLOCK AND REQUIRED INTERVENTION. AN ANALYSIS WAS PERFORMED ON THE PICTURE THAT WAS PROVIDED BY THE CUSTOMER. A PICTURE SHOWING THE CATHETER WAS RECEIVED FOR ANALYSIS, THE PHOTO DOES NOT PROVIDE SUFFICIENT INFORMATION RELATED TO THE REPORTED EVENT AND THEREFORE NO RESULT CAN BE OBTAINED FROM IT. THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. THE PRODUCT ANALYSIS WAS PERFORMED AS APPROPRIATE IN ORDER TO FIND THE ROOT CAUSE OF THE COMPLAINT. THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER FOR EVALUATION. A VISUAL INSPECTION, OF THE RETURNED DEVICE, WAS PERFORMED IN ACCORDANCE WITH BWI PROCEDURES. VISUAL ANALYSIS OF THE RETURNED PENTARAY NAV ECO DEVICE REVEALED THAT THE SHAFT OF THE DEVICE HAD BEEN CUT OFF. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE (B)(6), AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. PHYSICIAN'S OPINION REGARDING THE ADVERSE EVENT WAS PROCEDURE. IN ADDITION, PHYSICAL DAMAGE WAS NOT REPORTED ON THE RING, ELECTRODE OR OTHER AREA AT THE END OF THE CATHETER. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. H6. INVESTIGATION FINDINGS CODE OF ¿APPROPRIATE TERM/CODE NOT AVAILABLE¿ REPRESENTS PHOTO/VIDEO ANALYSIS. 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 BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION ON 03-FEB-2022. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. 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 AN UNKNOWN ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER BECAME STUCK IN THE TRICUSPID VALVE WHICH CAUSED HEART BLOCK AND REQUIRED INTERVENTION. WHEN TRYING TO MAP THE RIGHT VENTRICLE WITH PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER, THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER STOPPED MOVING NEAR THE TRICUSPID VALVE AND COULD NOT BE REMOVED FROM THE PATIENT¿S BODY. WHEN IT WAS MOVING THE CATHETER TO REMOVE THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER, AV BLOCK DEVELOPED AND CONTINUED FOR ABOUT 30 MINUTES. THE HANDLE PART OF THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER WAS CUT OFF, AND THE USED SHEATH WAS REMOVED. PLACE AN 8FR LONG SHEATH OVER THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER FROM THE PROXIMAL SIDE AND INSERT THE SHEATH INTO THE BODY. THE 8FR SHEATH WAS PLACED UP TO THE TIP OF THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER, AND THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER WAS REMOVED. THEN MAPPING WITH DECANAV CATHETER. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. AFTER THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER WAS REMOVED, AV BLOCK CONTINUED FOR ABOUT 30 MINUTES, BUT RESOLVED DURING THE PROCEDURE. NO PARTICULAR ABNORMALITY WAS NOTED AT THE TIME OF DISCHARGE. THE PHYSICIAN COMMENTED THAT CATHETER MIGHT HAVE BEEN TURNED TOO FAR AND CAUGHT IN A HEALTH CORD. PROLONGATION OF MEDICAL PROCEDURES INCLUDING DRUG ADMINISTRATION AND HOSPITALIZATION FOR AV BLOCK. NO TREATMENT WAS CONDUCTED AT THE END OF THE PROCEDURE. ABNORMALITIES IN VALVE FUNCTION AND CARDIAC TISSUE IN PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER STACKING. NO ABNORMAL FINDINGS WERE NOTED AT THE END OF THE PROCEDURE. ADDITIONAL INFORMATION: THE AV BLOCK CONTINUED FOR ABOUT 30 MINUTES, BUT IT WAS SOLVED DURING THE PROCEDURE. THERE WAS NO PARTICULAR ABNORMALITY WHEN LEAVING. FOR AV BLOCK, MEDICAL TREATMENT INCLUDING DRUG ADMINISTRATION AND EXTENSION OF HOSPITALIZATION PERIOD. NONE AT THE END OF THE PROCEDURE. REGARDING THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER STACK, ABNORMALITIES IN VALVE FUNCTION AND CARDIAC TISSUE. NONE AT THE END OF THE PROCEDURE. SINCE THE ADVERSE EVENT IS LIFE THREATENING AND IT MIGHT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE AND IT REQUIRED MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, IT IS TO BE CONSIDERED SERIOUS AND MDR-REPORTABLE. SURGICAL INTERVENTION WAS REQUIRED OR A SERIOUS INJURY OCCURRED, THEREFORE, THE MEDICAL DEVICE ENTRAPMENT ISSUE WAS ASSESSED AS MDR REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217178 PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC D128211 30228671L 10846835012255

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention| H 7FR DECAN,11P,D,2.4MMLE,282MM,| DEF 5FR,CC,5P,PRE-A,2MM LE| THMCL SMTCH SF BID, TC, D-F| UNKNOWN BRAND 8FR LONG SHEATH