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 11/11/2021

Event Type  Injury  

Event Description

It was reported that a (b)(6) male patient (b)(6) underwent an atrial flutter (afl) procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered third degree heart block requiring pacemaker implantation.It was reported that during ablation of the cavotricuspid isthmus line and with termination of the atrial flutter, the patient exhibited third degree heart block.It was reported that the patient was receiving a permanent pacemaker implant at the time.The reporter stated that the physician was already preparing to implant a permanent pacemaker due to the patient's low underlying heart rate prior to the ablation.The patient was reported to be stable.This adverse event was discovered during use of bwi products.The physician¿s opinion on the cause of this adverse event was the patients underlying condition.The outcome of the adverse event: pacemaker implant.Additional information: the adverse event occurred on (b)(6) 2021.The patient stayed overnight because it was an in-house patient.Biosense webster smartablate generator serial number (b)(4).A thermocool® smarttouch® sf catheter was used.Force visualization features used: graph, dashboard, vector, and visitag.The visitag module was used and the parameters for stability were 1.5mm distance change, 5sec minimum time.Additional filter used with the visitag was 35% of 5g of force, respiration adjustment on.Color option used prospectively was tag index.Since the event is 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 is to be considered serious and mdr-reportable.

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 finished device number 30617096l, and no internal actions related to the reported complaint condition were identified.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.(b)(4).

Manufacturer Narrative

On 20-dec-2021, bwi received an update to the catalog number.The catheter used in this case was an stsf fj curve with product number (b)(4).The catalog number and unique identifier in section d of this form have been updated accordingly.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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12931883
• MDR Text Key: 283089162
• Report Number: 2029046-2021-02094
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/04/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2022
• Device Model Number: D134805
• Device Catalogue Number: D134804
• Device Lot Number: 30617096L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/05/2021
• Supplement Dates Manufacturer Received: 12/16/2021
• Supplement Dates FDA Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2021
• 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: CARTO 3 SYSTEM.; SMARTABLATE GENERATOR.; VISITAG MODULE.
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 87 YR
• Patient Sex: Male