BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER

    MDR report key: 16154278 · Received January 12, 2023

    Report

    Report Number
    2029046-2023-00087
    Event Type
    Malfunction
    Date Received
    January 12, 2023
    Date of Event
    August 24, 2022
    Report Date
    January 12, 2023
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012224
    PMA / PMN Number
    K123837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER INC (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. A VISUAL INSPECTION AND AN ELECTRICAL TEST OF THE RETURNED DEVICE WERE PERFORMED IN ACCORDANCE WITH BWI PROCEDURES. VISUAL ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE SPLINE B WAS BENT, ALSO THE ELECTRODES ON SPLINE B WERE CRUSHED, BENT, WITH ROUGH EDGES AND WITHOUT PU (POLYURETHANE) ON THE EDGES; ADDITIONALLY, A WHITE FIBER WAS FOUND ATTACHED TO THREE OF THE ELECTRODES. AN ELECTRICAL TEST WAS PERFORMED, AND OPEN CIRCUITS WERE FOUND ON THE DAMAGED ELECTRODES. AN FTIR (FOURIER TRANSFORM INFRARED SPECTROSCOPY) ANALYSIS WAS PERFORMED TO DETERMINE THE COMPOSITION OF THE WHITE FIBER AND THE RESULTS SHOWED THAT THE MATERIAL WAS PRIMARILY COMPOSED OF ABS (ACRYLONITRILE BUTADIENE STYRENE) WHICH COULD BELONG TO ANOTHER DEVICE USED DURING THE PROCEDURE. THE SOURCE OF THE DAMAGE TO THE ELECTRODES REMAINS UNKNOWN AS THERE¿S NOT ENOUGH INFORMATION TO REACH A DEFINITIVE CONCLUSION, BUT A SUDDEN MOVEMENT AND THE USE OF INCOMPATIBLE DEVICES ALONG WITH THE PENTARAY NAV ECO DEVICE COULD BE RELATED TO THE DAMAGE, WHICH LATER CAUSED THE ELECTRICAL ISSUES OBSERVED BY THE CUSTOMER. 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 FOR THE FINISHED DEVICE 30760868L, AND NO INTERNAL ACTION WAS FOUND DURING THE REVIEW. THE ISSUES REPORTED BY THE CUSTOMER WERE CONFIRMED. THE INSTRUCTIONS FOR USE CONTAIN (IFU) THE FOLLOWING RECOMMENDATIONS: DO NOT INTRODUCE THE CATHETER INTO A GUIDING SHEATH WITH THE CATHETER¿S DISTAL SPINES FOLDED BACKWARD TOWARD THE HANDLE. COLLAPSE THE SPINES TOGETHER USING THE INSERTION TUBE PRIOR TO INSERTION. THE CATHETER IS RECOMMENDED FOR USE WITH AN 8F GUIDING SHEATH BECAUSE THE DISTAL SPINES MAY BE DAMAGED IF USED WITH A SHEATH THAT IS NOT COMPATIBLE. DO NOT USE THE CATHETER IN CONJUNCTION WITH TRANSSEPTAL SHEATHS FEATURING SIDE HOLES LARGER THAN 1.25MM IN DIAMETER. DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER THROUGH THE GUIDING SHEATH WHEN RESISTANCE IS ENCOUNTERED. AS PART OF BIOSENSE WEBSTER¿S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. EXPLANATION OF CODES: INVESTIGATION FINDINGS: INAPPROPRIATE MATERIAL (C0602), STRESS PROBLEM IDENTIFIED (C0706) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: ELECTRODE (G0201501) WERE SELECTED AS RELATED TO THE ISSUES OF FOREIGN MATERIAL, NOISE AND ELECTRODES DAMAGE. INVESTIGATION FINDINGS: MECHANICAL PROBLEM IDENTIFIED (C07) / INVESTIGATION CONCLUSIONS: CAUSE NOT ESTABLISHED (D15) / COMPONENT CODE: TIP (G04129) WERE SELECTED AS RELATED TO THE BENT SPLINE. 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 FIBRILATION (AFIB) - PERSISTENT ABLATION PROCEDURE WITH A PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER FOR WHICH BIOSENSE WEBSTER¿S PRODUCT ANALYSIS LAB (PAL) IDENTIFIED ELECTRODE DAMAGE. IT WAS INITIALLY REPORTED BY THE CUSTOMER THAT THERE WAS NO VISUAL PROBLEM OPENING THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER FROM THE BOX. SIGNAL ON SOME PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER SPLINE HAD NOISE AND THEY ARE PHYSICALLY DAMAGE AFTER WE REMOVE THE PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER OUTSIDE OF THE PATIENT. BEFORE THAT IT WAS WITH NO PROBLEM. DURING THE DEPLOYMENT OF THE SPLINE IN THE LEFT ATRIUM, THE DIPOLES 5-6 AND 7-8 PROVED TO BE NON-FUNCTIONAL. THE DEVICE WAS THEREFORE REMOVED FOR VERIFICATION AND IT WAS FOUND THAT ONE SPLINE WAS BENT. A DEVICE CHANGE HAS BEEN MADE TO CONTINUE THE PROCEDURE. THE CUSTOMER¿S REPORTED ISSUES OF NOISE AND BENTS IN THE SPLINES ARE NOT CONSIDERED TO BE MDR REPORTABLE SINCE THE POTENTIAL THAT THESE COULD CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY, OR OTHER SIGNIFICANT ADVERSE EVENT, IS REMOTE. ON (B)(6) 2022, THE BWI PAL REVEALED THAT A VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE SPLINE B WAS BENT, ALSO THE ELECTRODES ON SPLINE B WERE CRUSHED, BENT, WITH ROUGH EDGES AND WITHOUT PU (POLYURETHANE) ON THE EDGES; ADDITIONALLY, A WHITE FIBER WAS FOUND ATTACHED TO THREE OF THE ELECTRODES. THESE FINDINGS WERE REVIEWED AND DETERMINED THE ISSUES OF ELECTRODE DAMAGE AND FOREIGN MATERIAL ON THE ELECTRODES ARE CONSIDERED TO BE MDR REPORTABLE MALFUNCTIONS SINCE THE INTEGRITY OF THE DEVICE HAS BEEN COMPROMISED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2073981 PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC D128208 30760868L 10846835012224

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PENTARAY NAV ECO 7FR, F, 2-6-2