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

Model Number D134805

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Tamponade (2226); No Code Available (3191)

Event Date 09/25/2020

Event Type  Injury  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).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 patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring surgical intervention.During the procedure, transseptal puncture was performed to access the left atrium (la).In the third ablation to the la, the patient¿s blood pressure dropped from 140 to 60.Pericardial effusion was then confirmed by echocardiography.Reminder of the procedure was aborted.The patient was sent to the operating room, and thoracotomy was performed.Drainage with a small incision during the operation was done.Prolonged hospitalization was required; on (b)(6) 2020, information was provided that the patient was in the hospital and was planned to be discharged next week.The physician had no comments regarding the usage of the bwi product.Physician commented that since he invaded the la side from a place different than the puncture site during transseptal, it might have damaged the septum.No bwi product malfunctions nor error messages were reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Should more information become available, it will be reviewed and processed accordingly.Since the adverse event was discovered after ablation was already delivered, the ablation catheter cannot be excluded; therefore, this is being coded and reported under the thermocool® smart touch® sf bi-directional navigation catheter.

Manufacturer Narrative

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 surgical intervention.The patient was sent to the operating room, and thoracotomy was performed.Drainage with a small incision during the operation was done.Prolonged hospitalization was required; on (b)(6) 2020, information was provided that the patient was in the hospital and was planned to be discharged next week.The physician had no comments regarding the usage of the bwi product.Physician commented that since he invaded the la side from a place different than the puncture site during transseptal, it might have damaged the septum.No bwi product malfunctions nor error messages were reported.Device evaluation details: the device evaluation has been completed.The device was visually inspected, and no physical damage was found.A deflection test was performed, and the curve deflect correctly, then an electrical test was performed, and no issue was found.Additionally, the device was tested for stockert generator compatibility and it passed; the temperature was displayed properly on the generator.After that an irrigation test was performed, and the test passed, finally a patency test was performed, and it passed.A manufacturing record evaluation was performed for the finished device, and no internal action related to the complaint was found during the review.The device passed all specifications.The root cause of the adverse event remains unknown.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.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

On 1/24/2021, additional information about the patient and event were received.It was reported the patient was a 58-year-old male.Patient¿s condition had improved.Physician relates the causality of the event to the procedure and commented that since he invaded the la side from a place different than the puncture site during transseptal, it might have damaged the septum.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: 10731619
• MDR Text Key: 212998123
• Report Number: 2029046-2020-01549
• 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: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/08/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30387862M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Date Manufacturer Received: 01/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SOUNDSTAR ECO SMS 8F CATHETER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 58 YR