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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Heart Block (4444)

Event Date 05/15/2023

Event Type  Injury  

Manufacturer Narrative

E 1.Initial reporter phone : (b)(6).Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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 a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient experienced heart block av.It was reported that an ablation of premature ventricular contractions (pvc) was performed.During the ablation near his, transient heart block occurred, and temporary pacemaker was placed.The patient was observed in the catheter lab for a while and showed signs of recovery to the point where one-to-one conduction was obtained, and he left the room.On (b)(6) 2023 a pacemaker was implanted due to heart block.The hospitalization was extended.Description of health hazard was a heart block.The physician's judgment on health hazard was that it was non-serious (moderate/minor).Contact force (cf) monitoring methods were real time graph, dashboard, vector, visitag.The visitag coloring setting was tag index.The physician's comment on the relationship between the event and the product was that no product-related malfunction was observed.There were no abnormalities observed before and while using the product.This adverse event was discovered during use of biosense webster products.No device malfunctions have occurred.During the procedure, a temporary pacemaker was placed for the transient heart block.Four days after the procedure, a leadless pacemaker was implanted for the heart block.The outcome of the adverse event is patient improved.On 25-may-2023, additional information was received stating that the correct event date is (b)(6) 2023.As such, the event date on this report is (b)(6) 2023.However, on 13-jun-2023, additional information was received stating that the adverse event occurred on (b)(6) 2023.Additional information was requested to clarify the correct event date.

Manufacturer Narrative

Additional information was received on 06-jul-2023 confirming that the correct event date is 15-may-2023.Therefore, the b3 date of event was updated.In addition, the patient weight was provided, therefore, section a.Patient information was updated.Medical history of type 2 diabetes was reported and b 7.Medical history/preexisting condition was updated.Also on (b)(6) 2023, the smartablate generator information was provided and the concomitant product section was updated.In addition, the lot number for the thermocool® smart touch® sf bi-directional navigation catheter was provided.Therefore, d 4.Lot, d 4.Expiration date and h 4.Device manufacture date have been updated.A manufacturing record evaluation was performed for the finished device number lot 31002354l 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: 17148059
• MDR Text Key: 317454653
• Report Number: 2029046-2023-01308
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 31002354L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2023
• 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: SMARTABLATE GEN. KIT (JAPAN); UNK_CARTO 3
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 60 KG