MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 03/11/2024

Event Type  Injury  

Manufacturer Narrative

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 number lot 31233457l and no internal actions 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 atrial flutter right (r-afl) ablation with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced pericardial effusion that required pericardiocentesis.During the procedure, the patient developed a pericardial effusion.A pericardiocentesis was performed with 200 ccs removed from the pericardial space.The patient was stable and was transferred to the critical care unit (ccu) for observation.They were using the smartablate generator.Settings: 40watts for 30 seconds.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

Additional information was received on 21-mar-2024.The adverse event was discovered during use of the biosense webster products.Event occurred during ablation.The physician's opinion on the cause of this adverse event is biosense webster, inc.(bwi) product malfunction.Correct catheter settings were selected on the generator.The pump switched from low to high flow during ablation.No error messages observed on biosense webster equipment during the procedure.Patient did not require extended hospitalization, patient stayed overnight per regular procedure.No transseptal puncture was performed.Ablation was performed prior to noting the pericardial effusion.There was evidence of steam pop.In addition, patient information was provided.Therefore, processed a.Patient information section.Also, additional concomitant products of unk carto 3 and unk pump were provided.Therefore, added to d 10.Concomitant medical products and therapy dates section.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4) during an internal review on 15-apr-2024, correction noted to the d10.Concomitant medical products and therapy dates section under the 3500a initial.Reported thmcl smtch sf bid, tc, d-f, but it should have been smartablate generator.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION 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: 19008972
• MDR Text Key: 338980666
• Report Number: 2029046-2024-01070
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31233457L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2024
• 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: SMARTABLATE GENERATOR; THMCL SMTCH SF BID, TC, D-F; UNK PUMP; UNK_CARTO 3
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 59 KG