MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	D133603
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	12/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional physician name: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Investigation is in progress, once completed a supplemental will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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).
Event or Problem Description
It was reported that a patient underwent an ischemic ventricular tachycardia - left (l-isvt) with a thermocool® smart touch¿ electrophysiology catheter.The patient suffered a cardiac tamponade requiring a pericardiocentesis.During the vt ablation with the thermocool® smart touch¿ electrophysiology catheter, it was noticed that patient blood pressure dropped.Cardiac echography revealed a cardiac tamponade that was controlled by a pericardiocentesis.No further complication that they have knowledge, vt ablation procedure was finished.Surgery was delayed due to the reported event for 90 minutes.Procedure was successfully completed.Additional information was received.The event happened intra-op, during use of biosense webster products.It was not known for sure what caused the event, but it was discovered in mid of an ablation session with the thermocool® smart touch¿ electrophysiology catheter.In opinion of the physician, event was attributable to the patient condition: apical aneurysm and the procedure.It was not suspected that there was a product failure.Patient's condition was improved.Tamponade was controlled during the procedure, and vt ablation procedure was completed.Patient left lab in stable condition.No extended hospitalization was required.The pericardial effusion was noticed after ablation.The event occurred during the ablation phase.The irrigated catheter had default flow settings for the thermocol smarttouch catheter.The pump was switching from "low" to "high" during ablation.No errors or warnings on smartablate generator or carto system.Force visualization features were dashboard and vector.Parameters for stability were range: 4.Time: 3.25% over 2 gr.3 mm tag size.Respiration adjustment additional filter used with the visitag.Tag index color option was used.Transseptal puncture was performed with non-biosense products: st jude brk transeptal needle, swartz braided transeptal guiding.Product is not available for return.It was discarded after end of procedure.
Additional Manufacturer Narrative
The investigation was completed on 03-mar-2023.The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30868480m number, and no internal action related to the complaint was found during the review.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: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: 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 ; MX
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16212861
• Report Number: 2029046-2023-00130
• Device Sequence Number: 4327356
• Product Code: LPB
• UDI-Device Identifier: 10846835009019
• UDI-Public: 10846835009019
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P030031/S053
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2023

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 Expiration Date: 08/03/2025
• Device Model Number: D133603
• Device Catalogue Number: D133603
• Device Lot Number: 30868480M
• 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: 12/23/2022
• Supplement Date Received by Manufacturer: 03/03/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 03/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2022
• 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: NON BWI-ST. JUDE BRK TRANSEPTAL NEEDLE.; NON BWI-SWARTZ BRAIDED TRANSEPTAL GUIDING.; SMARTABLATE GENERATOR KIT-WW.; UNKNOWN BRAND PUMP.; UNK_CARTO 3.
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 80 KG