BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY

    MDR report key: 15244135 · Received August 17, 2022

    Report

    Report Number
    2029046-2022-01901
    Event Type
    Malfunction
    Date Received
    August 17, 2022
    Date of Event
    July 22, 2022
    Report Date
    December 20, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835023015
    PMA / PMN Number
    K211438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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. INITIAL REPORTER PHONE: (B)(6). 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 TACHYCARDIA (AT) ABLATION PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND AN ISSUE OF FOREIGN MATERIAL WAS ENCOUNTERED. IT WAS REPORTED THAT AT THE TIME OF REMOVAL OF OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY FROM THE PATIENT'S BODY, A WHITE STRING LOOKED LIKE IT WAS PULLED AT THE SAME TIME. THE PHYSICIAN COMMENTED THAT IT MIGHT HAVE BEEN SUSPECTED THAT THE ELECTRODES MIGHT HAVE BEEN SCRATCHED INSIDE THE SHEATH (AGILIS SHEATH, 8.5FR.), RESULTING IN ABRASION. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER INC (BWI) FOR EVALUATION AND THE EVALUATION HAS BEEN COMPLETED. A VISUAL INSPECTION AND FUNCTIONAL TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED ELECTRODES WERE BENTS, SQUASHED, LIFTED AND WITH THE ELECTRODE POLYURETHANE (PU) BORDER DAMAGED; AND FOREIGN MATERIAL WAS FOUND IN ONE OF THEM. NO OTHER PHYSICAL DAMAGE WAS OBSERVED. FOREIGN MATERIAL WAS SENT TO AN INFRA-RED ANALYSIS (FTIR). INFRARED DATA REVEALED THAT FOREIGN MATERIAL WAS PRIMARILY COMPOSED OF POLYSTYRENE. THE SOURCE OF ORIGIN: ABBOTT INFORMED THAT THE FIBERS WERE CONFIRMED TO BE ORIGINATED AZILIS. THE FOREIGN MATERIAL ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED, THIS MATERIAL COULD BE RELATED TO THE DAMAGED ELECTRODES. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. AS PART OF BIOSENSE WEBSTER¿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 REF. #(B)(4).

    Additional Manufacturer Narrative · 0

    ON 15-SEP-2022, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THERE WERE NO REPORTS OF DAMAGE TO THE CATHETER ITSELF. THERE WAS NO RESISTANCE OR DIFFICULTY DURING INSERTION OR REMOVAL OF THE DEVICE. THERE HAS BEEN NO REPORTS OF PART DETACHMENTS TO THE CATHETER ITSELF. 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

    ON 14-OCT-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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL TACHYCARDIA (AT) ABLATION PROCEDURE WITH AN OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY AND AN ISSUE OF FOREIGN MATERIAL WAS ENCOUNTERED. IT WAS REPORTED THAT AT THE TIME OF REMOVAL OF OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY FROM THE PATIENT'S BODY, A WHITE STRING LOOKED LIKE IT WAS PULLED AT THE SAME TIME. THE PHYSICIAN COMMENTED THAT IT MIGHT HAVE BEEN SUSPECTED THAT THE ELECTRODES MIGHT HAVE BEEN SCRATCHED INSIDE THE SHEATH (AGILIS SHEATH, 8.5FR.), RESULTING IN ABRASION. NO REPLACEMENT OF THE OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY WAS NEEDED SINCE THE ISSUE OCCURRED WHILE REMOVING THE CATHETER FROM THE PATIENT'S BODY; AT THE END OF THE PROCEDURE. THERE WAS NO PATIENT ADVERSE EVENT. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT'S CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1711741 OPTRELL MAPPING CATHETER WITH TRUEREF TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC D140901 30757435M 10846835023015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown AGILIS SHEATH, 8.5FR