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 11/30/2020

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.A manufacturing record evaluation was performed for the finished device 30426682l 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.(b)(6).Manufacturer's ref.#(b)(4).

Event Description

It was reported that a patient underwent cardiac ablation procedure thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.Following the procedure, while in holding, it was discovered that the patient's blood pressure began to drop.A transthoracic echo was performed and a pericardial effusion was observed.The patient was brought back into the operating theatre and a transesophageal echo (toe) and pericardiocentesis were performed.The physician¿s opinion is that the event was related to an existing condition.The patient¿s condition required a week stay.They are fully recovered with no pericardial effusion (pe) reported at clinic follow up.Transseptal was performed with an abbott brk needle.The event occurred after ablation was performed after the use of biosense webster products.There was no evidence of steam pop.The exact timing of when the effusion happened is unknown.Standard irrigation settings were used (8-15ml/min).No error messages were observed on biosense webster equipment during the procedure.Dashboard and vector were used for force visualization.

Manufacturer Narrative

On (b)(6) 2021, the event date was reported to be (b)(6) 2020, as such, field b3.Date of event has been populated with this date.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: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 11083912
• MDR Text Key: 224129396
• Report Number: 2029046-2020-01995
• 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: 11/30/2020

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: 08/31/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30426682L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/28/2020
• Supplement Dates Manufacturer Received: 01/11/2021
• Supplement Dates FDA Received: 02/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-0055-2018
• Patient Sequence Number: 1
• Treatment: ABBOTT BRK TRANSSEPTAL NEEDLE; ABBOTT BRK TRANSSEPTAL NEEDLE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention