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

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Heart Failure (2206)

Event Date 03/01/2020

Event Type  Injury  

Manufacturer Narrative

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.A manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.The date of event was defaulted to (b)(6) 2020 since the event month was reported as (b)(6) and the event year was reported as 2020, but the event day was reported as unknown.As such, the date has been defaulted to the first day of the month.(b)(6).Initial reporter facility name is unavailable.Follow up is in progress.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

During a clinical trial not sponsored by bwi (miyabi registry (b)(6)), it was reported that a patient underwent a cardiac ablation procedure for paroxysmal atrial fibrillation (afib) on (b)(6) 2020 with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac failure.The procedure was successfully completed.No bwi product malfunctions were reported.Post-procedure (3/unk/2020), the patient developed cardiac failure.The principal investigator assessed this event as serious, not related to the study device and not related to the procedure.There¿s no indication regarding medical intervention or prolonged hospitalization.On (b)(6) 2020, the patient recovered from the issue.Despite this event being assessed as not related to the procedure and device, it is being conservatively reported as ¿cardiac failure¿ under the thermocool® smart touch® sf bi-directional navigation catheter.Further follow-up is to be sent to clarify the relationship assigned by the principal investigator.Should more information become available, it will be reviewed and processed accordingly.

Manufacturer Narrative

On 12/1/2020, biosense webster inc received additional information indicating the patient was a 78 year-old male.The outcome of the adverse event is improved.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

On (b)(6) 2021, the e 1.Initial reporter facility name was received as kokura memorial hospital.As such, the appropriate fields in section e1.Initial reporter have been populated.(b)(6) if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4)e1.Initial reporter postal code was corrected from (b)(6).

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 10753280
• MDR Text Key: 215108965
• Report Number: 2029046-2020-01584
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR