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

Model Number D134805

Device Problems High Readings (2459); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/17/2021

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 reference number: (b)(4).

Event Description

It was reported that (b)(6) female underwent paroxysmal atrial fibrillation (afib) ablation procedure (b)(6) bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.The patient suffered a pericardial effusion.Superior left atrial ablation was being performed, and the physician felt a steam pop.There was an impedance rise noted.The caller stated that the average force was 26g but was varying.Initially, there was not an effusion noted, but after about 5 minutes there was a small effusion seen via ice.A pericardiocentesis was performed.The patient is currently stable.It was also reported that during set-up for the procedure, the lab staff initially opened an fj curve stsf catheter, and then the physician decided to use a df curve.It was also reported that the ablation catheter was "somersaulting" on the carto 3 map, right after the catheter was advanced into the left atrium to begin ablation.The catheter was replaced, and the issue was resolved.The procedure was continued.The caller is requesting a replacement catheter.The carto3 system is operating to specifications and is not responsible for the issue.This adverse event was discovered during use of bwi products.The physician¿s opinion on the cause of this adverse event: md thought there was extra force, force- related.A transseptal puncture was performed with a heartspan.Prior to noting the ct ablation was performed.There was evidence of steam pop.The event occurred during ablation phase.Irrigated catheter was used and the flow setting: 8/15 per ifu.No error messages were observed on biosense webster equipment during the procedure.The patient is hemodynamically stable at the time of the report.The effusion was discovered/noticed by ultrasound.The patient was admitted.Perforation was not suspected.Pericardiocentesis was performed and 300ml of fluid was removed.The tube was left in place.The procedure was abandoned.There was no evidence of any effusion present before the procedure.Force visualization features were used: graph, dashboard, vector & visitag with the visitag module parameters for stability: 3, 3, 25% @ 3, tag size 2mm and respiratory gating with tag index.Max wattage used: 50w, total lesions: 52 ablations, total ablation time: 6 min 14 secs, total fluid: 445 ml since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure and it may require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

On 13-dec-2021, the product investigation was completed.It was reported that 72-year-old female underwent paroxysmal atrial fibrillation (afib) ablation procedure thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.The patient suffered a pericardial effusion.Superior left atrial ablation was being performed, and the physician felt a steam pop.There was an impedance rise noted.The caller stated that the average force was 26g but was varying.Initially, there was not an effusion noted, but after about 5 minutes there was a small effusion seen via ice.A pericardiocentesis was performed.The patient is currently stable.Device evaluation details: the product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and an evaluation of all features of the catheter.Visual analysis of the returned product revealed that no damage or anomalies were observed on the smart touch bidirectional sf device.Per the event, several tests were performed.The magnetic, temperature and force features were tested and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device [(b)(6)] number, and no internal actions related to the reported complaint condition were identified.No malfunction was observed during the product analysis.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12970775
• MDR Text Key: 286254952
• Report Number: 2029046-2021-02145
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30537604M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/17/2021
• Initial Date FDA Received: 12/09/2021
• Supplement Dates Manufacturer Received: 12/13/2021
• Supplement Dates FDA Received: 01/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM.; PENTARAY ECO NAV.; SMARTABLATE GENERATOR.; SOUNDSTAR ECO CATHETER.; THERMOCOOL SMARTTOUCH DF CURVE.; THERMOCOOL SMARTTOUCH FJ CURVE.; VISITAG MODULE.
• Patient Age: 72 YR
• Patient Sex: Female