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

Model Number D133601

Device Problems High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 05/02/2023

Event Type  Injury  

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30969405m 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.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 Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ electrophysiology catheter.The patient suffered cardiac tamponade requiring a pericardiocentesis.It was reported that ablation went through heart wall which resulted in tamponade.Surgery delayed due to the reported event.Action taken when event occurred was that hospital staff called emergency situation.Procedure was not successfully completed.Intervention done was emergency situation, staff, anesthesia and blood removal from pericardial sack.Additional information was received.Intervention provided was acute intervention - urgent matter.Outcome of the adverse event was fully recovered (no residual effects).Patient required extended hospitalization because of the adverse event as the patient remained in the hospital that day they do not know for how long.Generator information was a g4c-0120.No servicing is needed.The event occurred during the ablation phase.Correct catheter settings were selected on the generator.Error messages observed on biosense webster equipment during the procedure was high impedance.No additional filter used with the visitag.The physician¿s opinion regarding the cause of this adverse event is unknown.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The adverse event was assessed as mdr reportable.Since the event was life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it was to be considered serious and mdr-reportable.The high impedance issue was assessed as non mdr reportable.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event, was remote.

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• 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: 17035221
• MDR Text Key: 316291982
• Report Number: 2029046-2023-01188
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835008982
• UDI-Public: 10846835008982
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D133601
• Device Catalogue Number: D133601
• Device Lot Number: 30969405M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2023
• 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: 7FR DECAN,11P,F,2.4MMLE,282MM,; SMARTABLATE GENERATOR KIT-WW; UNK_CARTO 3
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization