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

Catalog Number D134804

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Heart Block (4444)

Event Date 12/06/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a supraventricular tachycardia ablation with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced heart block that required "pacing".The patient came in with a pr interval of approximately 230ms.The physician came on ablation and the pr interval reached as high as 280ms.The pr interval did return to 230 ms.The physician stated the patient has significant av nodal disease, determined in the ep (electrophysiology) study.This occurred on (b)(6) 2023.This was discovered during the procedure, but the doctor felt that this did not happen because of ablation, and that the patient already had some type of av (atrioventricular) nodal disease.The physician was unsure how the patient's current post-procedure/post-hospitalization condition but their pr returned to 230ms by the time the case was done.The physician believed that the patient may need a pacemaker in the future.He also mentioned that this was possibly a hidden preexisting condition, and that ablation did not cause a prolonged pr.Although the physician believed that the ablation did not cause the adverse event, ablation did occur prior to the adverse event and the ablation catheter cannot be disassociated with the event.

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.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).

Manufacturer Narrative

On 5-jan-2024, the product investigation was completed as the device was discarded.A manufacturing record evaluation was performed for the finished device 31165607l 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® 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: 18432220
• MDR Text Key: 331860103
• Report Number: 2029046-2024-00017
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134804
• Device Lot Number: 31165607L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2023
• 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
• Patient Outcome(s): Life Threatening