MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D133602

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

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

Event Date 11/12/2019

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).(b)(4).The product has not returned for analysis; however, a picture was provided by the customer.Evaluation is still in progress.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.A manufacturing record evaluation was performed for the finished device 30263472m number, and no internal actions related to the complaint was found during the review.Manufacturer's reference # (b)(4).

Event Description

It was reported that a (b)(6)-year-old male patient ((b)(6) kg) with a history of persistent atrial fibrillation and atrial flutter underwent atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and cardiac tamponade requiring pericardiocentesis and later surgical intervention.During the ablation phase, a steam pop occurred.The pericardial effusion was noticed after successful completion of the pulmonary vein isolation and after starting the ablation in the cavotricuspid isthmus (cti).Pericardiocentesis was performed but the patient did not stabilize.The case was aborted, and the patient was transferred to the operating room (or) for open heart surgery.Extended hospitalization was required as a result of the adverse event.The patient was extubated on the next day and discharged 2 days later (total 3 days of hospitalization).The patient¿s outcome is fully recovered.The physician¿s opinion on the cause of the adverse event was the contact force reading was erroneous while applying lateral pressure on the cavotricuspid isthmus (cti) which led to the steam pop, perforation of the right atrium (ra) and a pericardial effusion.It was also reported that there was a ¿possible cardiac arrest¿, and no further information has been provided to confirm whether cardiac arrest had occurred.No error messages were observed on any biosense webster, inc.Equipment during the case.Transseptal puncture was performed with st.Jude medical brk-1 transseptal needle.The force visualization features used included graph, dashboard and vector.The parameters for stability used with the visitag module were 3 mm for 4 secs and 25% force over time with 5 g force.The color option used prospectively was time, however, the physician did not rely nor observe the visitag during the procedure.The standard flow settings on the smartablate generator were set at 17 ml/min for < 30 w and 30 ml/min for > 30 w.No additional filters were used with the visitag module.Steam pop is not considered to be a device malfunction.Steam pop is an expected physiological phenomenon.

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation on december 6, 2019, and it was reported that upon initial visual inspection there was no visual damage or anomalies observed.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Product complaint # (b)(4).

Manufacturer Narrative

Investigation summary it was reported that a 73-year-old male patient (84 kg) with a history of persistent atrial fibrillation and atrial flutter underwent atrial fibrillation (afib) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and cardiac tamponade requiring pericardiocentesis and later surgical intervention.During the ablation phase, a steam pop occurred.The pericardial effusion was noticed after successful completion of the pulmonary vein isolation and after starting the ablation in the cavotricuspid isthmus (cti).Pericardiocentesis was performed but the patient did not stabilize.The case was aborted, and the patient was transferred to the operating room (or) for open heart surgery.Extended hospitalization was required as a result of the adverse event.The patient was extubated on the next day and discharged 2 days later (total 3 days of hospitalization).The patient¿s outcome is fully recovered.The device was visually inspected, and it was found in good condition.The magnetic sensor was tested on carto and the catheter was properly visualized and no errors were observed.Then, the force sensor was tested, and it was working properly.The force values were observed within specifications.Then, electrical testing was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.Then, the irrigation and deflection tests were performed, and it was found within specifications.The catheter was irrigating and deflecting correctly.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint were identified.The customer complaint cannot be confirmed.The catheter 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.Additionally, the customer provided a photo of the procedure screen, however, no result could be obtained from it.Manufacturer's reference # (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9413986
• MDR Text Key: 180630941
• Report Number: 2029046-2019-03956
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009002
• UDI-Public: 10846835009002
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• 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: 11/12/2019

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: 07/23/2020
• Device Catalogue Number: D133602
• Device Lot Number: 30263472M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 12/04/2019
• Supplement Dates Manufacturer Received: 12/06/2019; 12/20/2019
• Supplement Dates FDA Received: 12/18/2019; 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; ST. JUDE MEDICAL BRK-1 TRANSSEPTAL NEEDLE; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 73 YR
• Patient Weight: 84