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

Model Number D134805

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

Patient Problems Arrhythmia (1721); No Code Available (3191)

Event Date 08/11/2020

Event Type  Injury  

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Investigation is in progress, once completed a supplemental will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(6).(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 a patient underwent atrial fibrillation (afib) ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter and suffered complete heart block requiring temporary pacemaker.Atrioventricular (av) block occurred after ablation of the kent bundle near the his.Lasso was placed in the superior vena cava (svc).Our company catheter in the body was shown only on the left [unclear ¿ a.Etlin].Temporarily [pacemaker] used and the procedure completed.The physician¿s commented that not related to product.Th block was resolved and the patient discharged.There was no report of extended hospitalization.

Manufacturer Narrative

Additional information was received on 10/8/2020.The patient¿s gender is male.The event was discovered during use of biosense webster products.The physician commented that there was no relationship between biosense webster product and this adverse event.The outcome is fully recovered.Therefore, a3.Sex was populated.In addition, the 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.The manufacturing record evaluation is in progress, once completed a supplemental will be submitted.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

A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.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; 33 technology drive; irvine CA 92618
• MDR Report Key: 10490822
• MDR Text Key: 205955944
• Report Number: 2029046-2020-01159
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• 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: 08/11/2020

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 Expiration Date: 03/22/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30364719M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 10/08/2020; 01/10/2021
• Supplement Dates FDA Received: 11/05/2020; 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM WITH CARTO MERGE.; LASSO NAV 2515,22P SPLITHANDLE.
• Patient Outcome(s): Required Intervention