MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number	UNK_WEBSTER CS WITH AUTO ID
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Death
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation and the patient died.After a pulmonary vein isolation (pvi) on the (b)(6), the patient left fine.The next day, at 2pm the patient died.At the time of reporting, the cause of death is unknown and an autopsy was ongoing.It has been mentioned that the ablation was done with a farapulse and drive catheters, and a webster coronary sinus (cs) catheter.Since the cause of death is unknown and details about the procedure is very limited, we cannot exclude biosense webster inc.(bwi) catheter as a contributing factor.Additional information is being requested for clarification.
Additional Manufacturer Narrative
Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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
On 08-jul-2024, additional information was received.It was reported that the case was mapped with a pentaray¿ catheter and ablated with boston scientific farawave¿ catheter and a faradrive¿ sheath was used.The patient had been well, and all his vitals were perfectly normal until saturday ((b)(6) 2024) late morning, when he first complained about discomfort.A computed tomography (ct) scan was ordered but the patient rapidly declined and died even though he had immediate assistance and a consultant present.Based on the additional information received, the most suspected device attributed to the death is the boston scientific farawave¿ catheter, since the ablation catheter delivers energy via direct contact with cardiac tissue.There were no reported malfunctions with the biosense webster inc.(bwi) catheters that were involved in the case.Therefore, h6.Health effect - clinical code, h6.Health effect - impact code, and h6.Medical device problem code have been updated.With the available information, the bwi product is to be considered a concomitant device in this event and no longer considered to be mdr reportable against the bwi webster cs catheter with auto id technology.Should more information become available in the future, the reportability decision will be reassessed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19621260
• Report Number: 2029046-2024-02115
• Device Sequence Number: 18193972
• Product Code: DRF
• UDI-Device Identifier: 10846835009972
• UDI-Public: 10846835009972
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: UNK_WEBSTER CS WITH AUTO ID
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM; UNKNOWN DRIVE CATHETER; UNKNOWN FARA PULSE CATHETER
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown