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 Cardiac Tamponade (2226)

Event Date 11/25/2020

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone is (b)(6).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.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 that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.During cavotricuspid isthmus (cti) block line ablation, there was a sharp drop-in patient¿s blood pressure.Cardiac tamponade was confirmed, and pericardiocentesis was performed to drain the fluid from the pericardial space.Blood was transfused and the patient was then moved to the operating room for urgent cardiac surgery.Patient's outcome is unknown.There was no information on whether prolonged hospitalization was required.Physician does not know what the cause of the adverse event was.No biosense webster, inc.Product malfunctions were reported.Additional information was later received where the physician commented that the patient's progress is recovering and that there would be no causal relationship with the product.

Manufacturer Narrative

Additional information was received on (b)(6) 2021.The patient is a female, 88-years old and weighing 40kg.The patient¿s condition has improved.The physician commented that the adverse event was not related to the biosense webster, inc.(bwi) product.There was no evidence of a steam pop.Therefore, the following fields were populated on this report: a2.Patient age at the time of event: (b)(6).A2.Age unit ¿ years.A3.Gender - female.A4.Weight of the patient ¿ 40.0.A4.Weight unit (b)(6).The investigation has been completed as of (b)(6) 2021.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.However, a manufacturing record evaluation was performed for the finished device 30427188m 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.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: 11056578
• MDR Text Key: 223176866
• Report Number: 2029046-2020-01969
• 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
• Report Date: 11/25/2020

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: 08/25/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30427188M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 02/14/2021
• Supplement Dates FDA Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 88 YR
• Patient Weight: 40