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

Model Number D134801

Device Problems Failure to Sense (1559); High Readings (2459); Electrical Shorting (2926); Patient Device Interaction Problem (4001)

Patient Problem Stroke/CVA (1770)

Event Date 04/14/2021

Event Type  Injury  

Manufacturer Narrative

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).

Event Description

It was reported that a female patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a stroke.It was reported that after the afib case post use of bwi device, the patient suffered a stroke.It was unknown did not know how the stroke was discovered, confirmed or what medical intervention was provided.It is unknown if the patient is in stable condition.It was reported that the carto 3 system was displaying a current leakage error 7.The team disconnected the ablation cable from the piu and the error cleared.When the cable has reconnected the error 7 was displayed.The reporter stated that there was no surface ecg on the carto 3 system and recording system.The cable was replaced without resolution.The catheter was replaced, and the carto 3 system was displaying a high force after zeroing.The caller also stated the carto 3 system displayed a force catheter sensor error 106.The cable was replaced without resolution.The catheter was replaced, and the issue was resolved.The procedure was continued.The carto 3 system is operating per specs and is not responsible for the product issue.The physician¿s opinion on the cause of this adverse event: patient condition.Outcome of the adverse event is unknown and it is also unknown if the patient require extended hospitalization because of the adverse event.The current leakage error was displayed due to a signal noise / signal loss issue.All ecg channels had signal interference (noise/loss) and the signal interference (noise/loss) was observed on carto and the recording system.Ecg signal was available for the physician to monitor the patient¿s heart rhythm on the anesthesia monitor.During the signal interference/loss, the affected catheter was inside the patient¿s body.Since the event is life threatening and required intervention and prolonged hospitalization to prevent permanent impairment of a body function or permanent damage to a body structure, is to be considered serious and mdr-reportable.This report is for the 1st of 2 thermocool® smart touch® sf bi-directional navigation catheters used during the procedure.The second (replacement) catheter was reported in manufacturer report number 2029046-2021-00754.

Manufacturer Narrative

On 6/3/2021, the product investigation was completed.It was reported that a female patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a stroke.It was reported that after the afib case post use of bwi device, the patient suffered a stroke.It was unknown did not know how the stroke was discovered, confirmed or what medical intervention was provided.It is unknown if the patient is in stable condition.Device evaluation details: the product was returned to biosense webster for evaluation.Bwi conducted a visual inspection and a evaluation of all features of the device.Visual analysis of the returned product revealed that no damage or anomalies were observed on the smart touch sf.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 30479778m number, and no internal action was found during the review.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.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: 11816456
• MDR Text Key: 250370289
• Report Number: 2029046-2021-00753
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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
• Report Date: 04/14/2021

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: 12/14/2021
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30479778M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Initial Date Manufacturer Received: 04/14/2021
• Initial Date FDA Received: 05/13/2021
• Supplement Dates Manufacturer Received: 06/03/2021
• Supplement Dates FDA Received: 06/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; RECORDING SYSTEM; UNSPECIFIED CATHETER CABLE; CARTO 3 SYSTEM; RECORDING SYSTEM; UNSPECIFIED CATHETER CABLE
• Patient Outcome(s): Life Threatening