MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNKNOWN SMART TOUCH BIDIRECTIONAL SF; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pulmonary Edema (2020)

Event Date 05/18/2023

Event Type  Death  

Event Description

It was reported that a patient underwent a atrial flutter left (l-afl) ablation procedure with an unknown smart touch bidirectional sf.The patient experienced a pulmonary edema and ultimately passed away.It was reported that midway through the case the anesthesiologist noticed that there was blood in the tube being used to intubate the patient.The medical team did not find any effusions during the case when they checked with the soundstar catheter.At some point after the procedure's completion, the patient had passed away due to having blood collected in the lungs.The medical team stated that a lasso catheter, an stsf catheter, a vizigo sheath, and a 10f sms soundstar catheter were used in the procedure.They were all discarded after the case and are not available for return.In physician¿s opinion, the cause of death was traumatic intubation.After finishing procedure, it was noted that there was no pericardial effusion, and everything was completed successfully.No intervention was done in the ep (electrophysiology) lab, in post operation after the procedure the patient was "coded".Relevant tests/laboratory data¿unknown.Generator information was smartablate generator serial number: (b)(6).The bwi clinician and medical safety officer assessment is as follows: "based upon the reporter, the adverse event was noted in the middle of the procedure suggesting that some cardiac ablation may have been provided.No soft tissue injury has been confirmed by the reporter (ie esophageal fistula).As a conservative measure, the death is being coded/captured on the cardiac ablation catheter unless further information is provided that can disassociate the death from the biosense webster device(s) that were utilized in the procedure." all deaths were bwi.Fda approved ¿ ce mark devices are involved are reportable.

Manufacturer Narrative

The device has been reported as discarded, therefore 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).

• Brand Name: UNKNOWN SMART TOUCH BIDIRECTIONAL SF
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 17128817
• MDR Text Key: 317204425
• Report Number: 2029046-2023-01289
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LASSO CATHETER; SMARTABLATE GENERATOR; SOUNDSTAR ECO 10F; VIZIGO SHEATH
• Patient Outcome(s): Life Threatening; Death
• Patient Age: 78 YR
• Patient Sex: Male