BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER

    MDR report key: 13797074 · Received March 17, 2022

    Report

    Report Number
    2029046-2022-00559
    Event Type
    Injury
    Date Received
    March 17, 2022
    Date of Event
    February 22, 2022
    Report Date
    May 2, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012255
    PMA / PMN Number
    K123837
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ON 18-MAR-2022, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE COMPLAINT DEVICE FOR EVALUATION. THE PRODUCT 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 REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    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 · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND MEDICAL DEVICE ENTANGLEMENT OCCURRED LEADING TO A SPLINE BREAKING OFF OF THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE SPLINE. DURING A PROCEDURE WHILE IN THE LEFT ATRIUM, THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER WAS TANGLED WITH ANOTHER CATHETER AND ONE OF THE SPLINES BROKE OFF. THE PHYSICIAN USED A SNARE TOOL AND WAS ABLE TO RETRIEVE THE SPLINE WITH NO INJURY TO THE PATIENT. THE PROCEDURE CONTINUED AND THEY DID CAVOTRICUSPID ISTHMUS (CTI) ABLATION IN THE RIGHT ATRIUM AND COMPLETED THE CASE. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED AS OF THE TIME OF THE CALL. THE PATIENT WAS STABLE THROUGHOUT. DEVICE EVALUATION DETAILS: THE PRODUCT WAS RETURNED TO BIOSENSE WEBSTER INC (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. BWI CONDUCTED A VISUAL INSPECTION OF THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT THE DISTAL SIDE OF THE SPINE WAS FOUND DETACHED, THE DETACHED AREA PRESENTED ELONGATION. ALL ELECTRODES WERE MISSING, AND INTERNAL COMPONENTS ARE EXPOSED IN THE TIP AREA ON THE PENTARAY NAV ECO CATHETER. ADDITIONALLY, THE CUSTOMER PROVIDED A PICTURE OF THE COMPLAINT DEVICE TO AID IN THE INVESTIGATION. ACCORDING TO THE PICTURE PROVIDED, ONE OF THE SPLINES IS DETACHED FROM THE TIP. ALL UNITS ARE INSPECTED PRIOR TO LEAVING THE FACILITY AS THERE ARE FUNCTIONAL TESTS AND INSPECTIONS AT CONTROL POINTS BASED ON THE PROCESS FLOW DIAGRAM (PFD) PER ITS PART NUMBER TO AVOID THIS TYPE OF DAMAGE FROM LEAVING THE FACILITY. A MANUFACTURING RECORD EVALUATION WAS PERFORMED, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. DURING THE INVESTIGATION, NO ISSUES WERE OBSERVED ON THE CATHETER THAT COULD CAUSE THE ENTANGLEMENT WITH ANOTHER CATHETER IT COULD BE RELATED TO THE PROCEDURE HOWEVER, THIS CANNOT BE CONCLUSIVELY DETERMINED., OTHER ISSUES OR CIRCUMSTANCES MAY HAVE OCCURRED DURING THE USAGE OF THE DEVICE THAT COMPROMISED ITS PERFORMANCE. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE PICTURE RECEIVED. 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 · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER AND MEDICAL DEVICE ENTANGLEMENT OCCURRED LEADING TO A SPLINE BREAKING OFF OF THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER. SURGICAL INTERVENTION WAS REQUIRED TO REMOVE THE SPLINE. DURING A PROCEDURE WHILE IN THE LEFT ATRIUM, THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER WAS TANGLED WITH ANOTHER CATHETER AND ONE OF THE SPLINES BROKE OFF. THE PHYSICIAN USED A SNARE TOOL AND WAS ABLE TO RETRIEVE THE SPLINE WITH NO INJURY TO THE PATIENT. THE PROCEDURE CONTINUED AND THEY DID CAVOTRICUSPID ISTHMUS (CTI) ABLATION IN THE RIGHT ATRIUM AND COMPLETED THE CASE. NO FURTHER MEDICAL INTERVENTION WAS REQUIRED AS OF THE TIME OF THE CALL. THE PATIENT WAS STABLE THROUGHOUT. IT IS UNKNOWN IF THE DAMAGE RESULTED IN WIRES AND/OR BRAID BEING EXPOSED OR LIFTED OR SHARP RINGS. AN AGILIS SHEATH WAS USED DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30184 PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC D128211 30716889L 10846835012255

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention AGILIS SHEATH| UNK_SMART TOUCH BIDIRECTIONAL SF| UNSPECIFIED CS CATHETER