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

Catalog Number SMART TOUCH UNIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 09/16/2021

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.Manufacturer's reference number: (b)(4).

Event Description

It was reported a male patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter.The patient suffered a cardiac tamponade requiring pericardiocentesis.The atrial fibrillation procedure was completed yesterday on (b)(6) 2021.The patient had a pericardial effusion which was found today.The reporter stated that everything went well yesterday during the procedure and only a small effusion was noticed.The patient was in observation.It is unknown to the caller how it was discovered or verified today.The caller was notified by someone else regarding today's event.The medical intervention provided was a pericardiocentesis and 600 ml of fluid were removed.The patient was reported to be in stable condition.Additional information was received on the event.The adverse event was the following day after the procedure.Product was discarded.This adverse event was discovered the next day after using bwi products.The physician¿s opinion on the cause of this adverse event was unknown.Last status known about the patient by the caller was that the patient was stable.Patient was tapped and 600ml was removed.The patient outcome of the adverse event was that the patient was stable.The reporter is unsure if the patient required extended hospitalization because of the adverse event.Transseptal puncture was performed.Prior to noting the cardiac tamponade, ablation was performed.There was no evidence of a steam pop.The event did not occur during the procedure.It occurred the next day.The correct catheter settings were selected on the generator.The pump was switching from low to high flow during ablation.No error messages were observed on biosense webster equipment during the procedure.

• Brand Name: THERMOCOOL SMART TOUCH SF UNI-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 ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12619225
• MDR Text Key: 280180389
• Report Number: 2029046-2021-01743
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/12/2021

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 Catalogue Number: SMART TOUCH UNIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/17/2021
• Initial Date FDA Received: 10/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Required Intervention