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

Model Number D134804

Device Problems Electrical Shorting (2926); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

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

Event Date 10/23/2020

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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient (male, (b)(6) years old) underwent cardiac ablation procedure for idiopathic ventricular tachycardia with a thermocool® smart touch® sf bi-directional navigation catheter where cardiac tamponade requiring surgical intervention and death.It was reported that a soundstar catheter sensor error 6150 displayed on the carto 3.The swiftlink was replaced without resolution.The catheter was replaced and the issue resolved briefly then was intermittent for the remainder of the procedure.It was also reported that during ablating in the left ventricle a steam pop occurred followed by a current leakage error 7 displayed on the carto 3.The ablation cable was replaced and the case continued.The physician declined to check the catheter for char at this time.Later in the procedure, another steam pop occurred along with error 7, current leakage, also in the left ventricle.The catheter was visualized in the right atrium.There was no loss of signals.The physician was unsure whether the catheter moved from the left ventricle to the right atrium via an anomaly in the patient anatomy or if this was due to ablation.The catheter was removed, and no char was noted.The procedure was aborted.The patient was under observation for a potential effusion but was stable at the time of the call.Physician's note post-procedure was "leaving the procedure, there were no complications, endocardial cushion defect noted.¿ it was reported that the patient was stable while in the electrophysiology (ep) lab, but hours later while in the surgical intensive care unit (sicu) a pericardial effusion was discovered.A pericardiocentesis was performed and 450 cc of fluid was removed.The patient's condition did not improve and a pericardial window was placed.The patient's condition still did not improve and the patient was taken to surgery where they attempted to fix the perforation.However, the patient did not improve and expired later that night.The physician¿s opinion is that the cause of the event was possible device malfunction or congenital defect.Ablation was done at 50w, with 8 lesions in the area of the perforation.No transseptal was performed.The flashing force warning was turned off per physician¿s request.Vizitag stability settings were 2mm/3sec and 3gr for 25% of the time.Impedance (5-10 ohms) were used for color option.The medical safety officer reviewed this event on 11/06/20 and determined that the left ventricle was perforated at the site of ablation and may have been related to steam pop.This is a known complication of procedure.The death outcome was as a result of the cardiac tamponade related to the cardiac perforation.Per report, no effusion or complication was noted at the time of the procedure.The effusion was slow growing suggesting that the perforation was not large.It was noted that the patient did have an endocardial cushion defect which is a congenital finding and therefore patient related.Steam pop is not an mdr-reportable issue.Current leakage error is not an mdr-reportable issue.Since cardiac tamponade was associated with the patient's death it is mdr-reportable.

Manufacturer Narrative

On 11/24/2020, the bwi product analysis lab received the device for evaluation.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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 12/10/2020, the product investigation was completed.It was reported that a patient (male, 64 years old) underwent cardiac ablation procedure for idiopathic ventricular tachycardia with a thermocool® smart touch® sf bi-directional navigation catheter where cardiac tamponade requiring surgical intervention and death.Device evaluation details: the device was visually inspected and it and it was found in good conditions.The magnetic, temperature and force features were tested and no issues were observed.In addition, the catheter was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device 30413151m number, and no internal action related to the reported complaint was found during the review.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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: 10837524
• MDR Text Key: 216184173
• Report Number: 2029046-2020-01687
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/22/2021
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30413151M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2020
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; DECANAV CATHETER; SOUNDSTAR ECO CATHETER; VIZIGO SHEATH; CARTO 3 SYSTEM; DECANAV CATHETER; SOUNDSTAR ECO CATHETER; VIZIGO SHEATH
• Patient Outcome(s): Death
• Patient Age: 64 YR