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

Model Number D132705

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

Patient Problems Death (1802); Cardiac Tamponade (2226); No Code Available (3191)

Event Date 09/08/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool smart touch bi-directional navigation catheter and suffered cardiac tamponade (requiring pericardiocentesis and surgical intervention) and death.During the procedure ventricular tachycardia (vt) induction started after catheter placement.The patient was unable to tolerate the vt and needed three defibrillation shocks to return to sinus rhythm.The right ventricle (rv) was mapped with the pentarray catheter and several areas of low voltage were identified.The catheter was then changed to a smart touch d/f for additional mapping.After zeroing the catheter, mapping of the low voltage areas in the right ventricle outflow tract (rvot), several warnings of high force were noticed.The patient¿s blood pressure dropped shortly after, and cardiac tamponade was diagnosed by ultrasound.Reminder of the procedure was aborted, and the epicardium was punctured for drainage.Quite difficult several attempts to puncture were made.Patient required 3 days of additional hospitalization.The patient seemed to be stabilized; however, patient become hypotensive again and was moved to the operating room (or) for thoracotomy.Patient died during surgery.There was a rupture of the rvot where the wall of the rvot was thin.Physician¿s opinion regarding the cause of the event is that it was procedure and patient condition related.Physician believes the rupture of rvot scar was caused by the smart touch catheter.Transseptal puncture was not performed during the case.No ablation was ever done.Standard low flow settings were used as no ablation was done.The reported high force issue is not mdr reportable since the issue is highly detectable when occurring.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event is low.

Manufacturer Narrative

On 11/24/2020, the bwi product analysis lab received the complaint device for evaluation.The product 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.Manufacturer's ref # (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and suffered cardiac tamponade (requiring pericardiocentesis and surgical intervention) and death.Device evaluation details: the device evaluation as been completed.The device was visually inspected, and no physical damage was found.Irrigation and deflection features were tested, and were found working correctly.After that, the catheter was connected to the carto 3 system and error 106 appeared and the catheter tip and temperature values were not visualized on the carto 3 system.It was determined this could be related to an open circuit identified inside the catheter tip and could be due to the handling of the device post procedure since there were no issues of temperature, visualization or error 106 reported by the customer.No ablation was performed during the procedure, therefore, these findings are not related to the adverse event.A manufacturing record evaluation was performed for the finished device, and no internal action related to the complaint was found during the review.The root cause of the adverse event remains unknown.The failures observed during analysis are not related to the reported event.In addition, physician¿s opinion regarding the cause of the event is that it was procedure and patient condition related.Furthermore, according to event description, it was likely caused by using too much force using the smart touch catheter, however, the instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.Code selection explanation: ¿no device problem found¿ (c19)/ ¿no problem detected¿ (c14) with the device as it related to the adverse event.As such, code ¿appropriate term/code not available¿ (g07002) was selected as the h6.Component code.¿open circuit¿ (c0205) / ¿cause not established¿ (d15) were selected as they relate to the failures identified during product analysis.As such, code ¿senor¿ (g03012) was selected as the h6.Component code.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 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: 10646280
• MDR Text Key: 210354303
• Report Number: 2029046-2020-01447
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• 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: 09/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/07/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/24/2021
• Device Model Number: D132705
• Device Catalogue Number: D132705
• Device Lot Number: 30372615M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK_PENTARAY; UNK_PENTARAY
• Patient Outcome(s): Death; Hospitalization; Required Intervention