MAUDE Adverse Event Report: BIOSENSE WEBSTER INC ESOPHASTAR; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number	F8ENNNNHSB
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heartburn/Indigestion (1883)
Date of Event	09/12/2023
Type of Reportable Event	Death
Additional Manufacturer Narrative
Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure using an unknown esophastar.The patient experienced epigastric discomfort post procedure and the patient ultimately ended up passing away.The patient underwent a cryoafib (cryo atrial fibrillation) case.The patient passed away after having stomach pains.Beyond some difficulty getting access to the groin, the medical team did not encounter procedural complications.This event is being captured on the esophastar as a conservative measure until further information is provided about the cause of death in this patient.The esophastar is associated with the esophagus which can be related to the patient's epigastric pain.
Additional Manufacturer Narrative
Correction to initial report.The product was reported as unknown; however the catalog number was available.Therefore, section 1.Brand name, d4.Catalog and d4.Primary udi number were updated.Udi related data quality updates only: d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.When the event was initially reported, the lot number was not available and unable to be obtained.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

• Brand Name: ESOPHASTAR
• 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: 17901895
• Report Number: 2029046-2023-02265
• Device Sequence Number: 7897598
• Product Code: DRF
• UDI-Device Identifier: 10846835008227
• UDI-Public: 10846835008227
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K061463
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2023

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: F8ENNNNHSB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 10/09/2023
• 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: OCTARAY CATHETER.; SOUNDSTAR CATHETER.
• Outcome Attributed to Adverse Event: Life Threatening; Death
• Patient Sex: Unknown