MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

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

Patient Problem Arrhythmia (1721)

Event Date 07/20/2020

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.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.(b)(4).Manufacturer's reference number: (b)(4).If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.

Event Description

It was reported that on (b)(6) 2020 a patient underwent cardiac ablation procedure for atrial fibrillation (afib) with thermocool® smart touch® sf bi-directional navigation catheter and suffered adverse events.On (b)(6) 2020, day of the procedure, the patient suffered complete heart block.No intervention nor extended hospitalization was reported.The issue was resolved after one week.The principal investigator (pi) assessed this event as not serious, not related to study procedure.Relationship to device was not provided.Since this is a recognized complication of cardiac ablation this event is coded as ¿heart block av¿.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Should more information become available in the future; the reportability decision will be reassessed.

Manufacturer Narrative

On 10/21/2020, biosense webster inc.Received additional information about the patient and event.It was reported the patient was an 83 year old female and the adverse event outcome 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 1/24/2021, additional information was received indicating the patient has fully recovered.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: UNK
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 10584003
• MDR Text Key: 208492301
• Report Number: 2029046-2020-01333
• 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: 09/08/2020

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 Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/08/2020
• Initial Date FDA Received: 09/24/2020
• Supplement Dates Manufacturer Received: 10/21/2020; 01/24/2021
• Supplement Dates FDA Received: 11/17/2020; 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR