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 12/02/2020

Event Type  Injury  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a male patient underwent cardiac ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring surgical intervention.After the procedure, post use of bwi products, it was discovered that blood was flowing to the epicardium, and a surgical thoracotomy was performed.; the pooled blood was aspirated.The patient's condition is stable.The endocardium and epicardium were adhered because the patient was after the operation.Blood was flowing outside the epicardium so they could not confirmed effusion by intracardiac echo, and this event was discovered due to a decrease in blood pressure after the operation completed.Originally, crtd (implantable cardioverter defibrillator) was implanted, and blood pressure dropped during atrial tachycardia (at) and atrial fibrillation (af), so it was difficult to distinguish during surgery.This event was diagnosed as cardiac tamponade.Suction of blood from the epicardium was applied as medical intervention.Transseptal puncture was performed.There was no evidence of steam pop.There was no report of any error messages occurred on bwi equipment.The physician commented that the causal relationship with the product was unknown.The outcome of the adverse event improved.The patient required extended hospitalization.

Manufacturer Narrative

It was reported that a male patient underwent cardiac ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring surgical intervention.After the procedure, it was discovered that blood was flowing to the epicardium, and a surgical thoracotomy was performed.; the pooled blood was aspirated.The patient's condition is stable.This event was diagnosed as cardiac tamponade.Suction of blood from the epicardium was applied as medical intervention.Device investigation details: 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 30430406m 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 ref.# (b)(4).

Manufacturer Narrative

Additional information was received indicating it is likely that prolonged hospitalization was required to recover from surgery.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: 11097559
• MDR Text Key: 224752952
• Report Number: 2029046-2020-02015
• 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: 12/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30430406M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention