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 Thrombosis/Thrombus (4440)

Event Date 03/03/2021

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.A manufacturing record evaluation was performed for the finished device 30445667m number, 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.Biosense webster manufacturer's reference number (b)(4) has two reports: for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter) and mfr # 2029046-2021-00420 for product code unk_soundstar (soundstar® eco diagnostic ultrasound catheter).

Event Description

It was reported that a male patient underwent an atrial fibrillation (afib) ablation procedure with athermocool® smart touch® sf bi-directional navigation catheter (stsf) and a soundstar catheter (product code unknown) and a clot issue occurred.During the procedure, immediately after going transseptal, a clot was discovered waving around in the right atrium.The physician decided to remove all the catheters to make sure nothing was stuck to the catheters.The clot was confirmed by intracardiac echocardiography (ice).Caller reported no medical intervention was provided but the procedure was immediately canceled.No ablation was performed but it was confirmed that the soundstar was in the right atrium and that the mapping catheter (stsf) was in the body as well.As such, it has been decided to report the event against both devices.The physician did not provide a causality opinion for the cause of this adverse event.The patient was reported to be in stable condition.

• 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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11576451
• MDR Text Key: 243347503
• Report Number: 2029046-2021-00419
• 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
• Report Date: 03/03/2021

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: 10/01/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30445667M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/03/2021
• Initial Date FDA Received: 03/26/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/02/2020
• 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
• Patient Outcome(s): Life Threatening