BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY

    MDR report key: 21044486 · Received December 30, 2024

    Report

    Report Number
    2029046-2024-04166
    Event Type
    Injury
    Date Received
    December 30, 2024
    Date of Event
    December 3, 2024
    Report Date
    May 16, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835009989
    PMA / PMN Number
    K080425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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

    ON 23-APR-2025, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE PRODUCT INVESTIGATION WAS SUBSEQUENTLY COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION - PAROXYSMAL ABLATION PROCEDURE WITH A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AND THE DEVICE WAS INSERTED INTO THE SHEATH AND PUSHED UP THE VEIN. THE CATHETER SLIPPED INTO THE HEPATIC VEIN WHERE IT GOT STUCK. IT COULD NOT BE WITHDRAWN AGAIN. THE CATHETER WAS CUT OPEN AND THEN PULLED OUT. AFTER VISUAL INSPECTION, A SMALL BUMP WAS FOUND ON THE CATHETER ELECTRODES, WHICH MAY HAVE LED TO THE SNAGGING. THE PROCEDURE HAD TO BE CANCELLED. THE CATHETER COULD BE COMPLETELY REMOVED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. A VISUAL AND DIMENSIONAL INSPECTIONS AND FOURIER TRANSFORMED INFRARED SPECTROSCOPY (FTIR) STUDY OF THE RETURNED DEVICE WERE PERFORMED IN ACCORDANCE WITH J&J MEDTECH PROCEDURES. VISUAL INSPECTION OF THE RETURNED SAMPLE REVEALED THAT THE SHAFT WAS CUT OFF FROM THE HANDLE; IN ADDITION, THE HANDLE WAS NOT RETURNED. FOREIGN MATERIAL WAS FOUND ATTACHED TO THE DOME, SECOND AND THIRD ELECTRODES; HOWEVER, NO LIFTED OR DENTED ELECTRODES WERE DETECTED. ALSO, THE TRANSITION OF THE TIP-SHAFT WAS FOUND SEPARATED; LEAVING INTERNAL PARTS EXPOSED. A MICROSCOPICAL INSPECTION OF THE DETACHED AREA WAS PERFORMED, AND EVIDENCE OF PROPER MANUFACTURING ASSEMBLY WAS FOUND AS ADHESIVE WAS OBSERVED ON THE AREA; HOWEVER, THE ADHESIVE WAS FOUND BROKEN. DUE TO THE FOREIGN MATERIAL OBSERVED, A FTIR ANALYSIS WAS REQUESTED AND THE STUDY REVEALED THAT THE MATERIAL WAS COMPOSED OF BIOLOGICAL SUBSTANCES INCLUDING TISSUE THAT PROBABLY ORIGINATED DURING THE MEDICAL PROCEDURE. IN ADDITION, A DIMENSIONAL INSPECTION WAS PERFORMED ON THE SHAFT, TIP AND ELECTRODES AND THE RESULTS WERE FOUND WITHIN SPECIFICATIONS. NO OTHER TESTS COULD BE PERFORMED DUE TO THE DEVICE CONDITION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31422048M AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. BASED ON THE DAMAGED OBSERVED THE EVENT DESCRIBED BY THE CUSTOMER WAS CONFIRMED. THE POTENTIAL CAUSE OF THE ENTRAPMENT ISSUE COULD BE RELATED TO THE PROCEDURE; HOWEVER, THIS COULD NOT BE ESTABLISHED CONCLUSIVELY. THE INTERNAL COMPONENTS EXPOSED, BROKEN TIP AND BROKEN SHAFT COULD BE CONSEQUENCE OF THE ENTRAPMENT ISSUE DESCRIBED AS IT WAS MENTIONED THAT THE CATHETER SLIPPED INTO THE HEPATIC VEIN WHERE IT GOT STUCK AND THE CATHETER WAS CUT OPEN AND THEN PULLED OUT. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. THE POTENTIAL CAUSE OF THE FOREIGN MATERIAL ATTACHED TO THE ELECTRODE COULD BE RELATED TO THE PROCEDURE; HOWEVER, THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING RECOMMENDATIONS: DO NOT USE EXCESSIVE FORCE TO ADVANCE OR WITHDRAW THE CATHETER. CAREFUL CATHETER MANIPULATION MUST BE PERFORMED IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. USE BOTH DIRECT IMAGING GUIDANCE (SUCH AS FLUOROSCOPY OR ULTRASOUND) AND ELECTROGRAMS TO MONITOR THE ADVANCEMENT OF THE CATHETER TO THE AREA OF THE ENDOCARDIUM UNDER INVESTIGATION TO AVOID VASCULAR OR CARDIAC DAMAGE. AS PART OF THE QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH J&J MEDTECH 'S QUALITY SYSTEM. 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

    ON 6-JAN-2025, THE PRODUCT INVESTIGATION WAS COMPLETED AS THE COMPLAINT DEVICE WAS NOT RETURNED FOR ANALYSIS. ADDITIONALLY, ON 15-JAN-2024, BWI RECEIVED ADDITIONAL INFORMATION REGARDING THE EVENT. PLANNED ROUTINE PROCEDURE FOR THE ABLATION OF ATRIAL FIBRILLATION USING THE 3D MAPPING SYSTEM CARTO3 (BIOSENSE WEBSTER) AFTER A PROBLEM-FREE PUNCTURE OF THE FEMORAL VEIN. THE CATHETER HAD BECOME STUCK IN A SIDE BRANCH OF THE VENA CAVA AND COULD NOT BE MOBILIZED AGAIN. IF THE CATHETER WAS MANIPULATED, THE PATIENT INDICATED PAIN IN THE AREA OF THE RIGHT SHOULDER, RADIOLOGICALLY THE CATHETER ENDED AT THE LEVEL OF THE LIVER/DIAPHRAGM, SONOGRAPHICALLY THE CATHETER COULD BE TRACED TO THE AREA OF THE LIVER GATE AND BEYOND, REMOVAL FROM THE LATERAL VESSEL WAS NOT POSSIBLE, BECAUSE THERE WAS A RISK OF A VEIN INJURY. THEREFORE, FIRST CT (COMPUTED TOMOGRAPHY) REPRESENTATION, IN WHICH THE CATHETER COULD BE TRACED INTO THE AREA OF THE DIAPHRAGM AFTER INTRATHORACAL PARACARDIAL. IN A SECOND STEP, SALVAGE TESTS IN THE CARDIAC CATHETER LABORATORY. THE CATHETER CONTROL HANDLE WAS CUT OFF TO REMOVE THE ACCESS SHEATH. AFTER THAT, A PART OF THE CATHETER (ESPECIALLY THE PLASTIC SHEATH) COULD BE REMOVED WITHOUT RESISTANCE, HOWEVER THE ELECTRODES OF THE CATHETER AND CORRESPONDING CABLES OF THE ELECTRONICS AND THE BOWDEN CABLE REMAINED IN THE PATIENT. BY INSERTING A LONG SHEATH OVER THE REMAINING WIRES THE CATHETER COULD OBVIOUSLY BE SPLINTED AND STRAIGHTENED TO SUCH AN EXTENT THAT A PROBLEM-FREE AND COMPLETE REMOVAL OF THE REMAINING CATHETER REMAINS UNDER FLUOROSCOPY CONTROL WAS FINALLY POSSIBLE. THE INSPECTION OF THE CATHETER TIP SHOWED A SMALL BUMP ON THE DISTAL ELECTRODE WITH MINIMAL TISSUE ATTACHMENT, WHICH MAY HAVE BEEN CAUGHT IN THE VENOUS TISSUE BY A VENOUS VALVE AND OBVIOUSLY PREVENTED THE CATHETER FROM RETRACTING SMOOTHLY. THE PATIENT SUFFERED NO SHORT-TERM OR PERMANENT DAMAGE. AS A RESULT, THE FOLLOWING H6 MEDICAL DEVICE PROBLEM CODES WERE ADDED: - MATERIAL PROTRUSION / EXTRUSION (A0411). - PATIENT DEVICE INTERACTION PROBLEM (A01). - ENTRAPMENT OF DEVICE (A150208). DEVICE INVESTIGATION DETAILS: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31422048M AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. 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).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION - PAROXYSMAL ABLATION PROCEDURE WITH A WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY AND THE DEVICE WAS INSERTED INTO THE SHEATH AND PUSHED UP THE VEIN. THE CATHETER SLIPPED INTO THE HEPATIC VEIN WHERE IT GOT STUCK. IT COULD NOT BE WITHDRAWN AGAIN. THE CATHETER WAS CUT OPEN AND THEN PULLED OUT. AFTER VISUAL INSPECTION, A SMALL BUMP WAS FOUND ON THE CATHETER ELECTRODES, WHICH MAY HAVE LED TO THE SNAGGING. THE PROCEDURE HAD TO BE CANCELLED. THE CATHETER COULD BE COMPLETELY REMOVED. THE PATIENT WAS NOT HARMED. PATIENT WAS TREATED ON THE NEXT DAY WITH ABLATION AND THE PROCEDURE WAS SUCCESSFULLY FINALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2128698 WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 31422048M 10846835009989

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK SHEATH