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

Model Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Transient Ischemic Attack (2109); Blurred Vision (2137)

Event Date 10/13/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).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 (b)(6) male patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered a transient ischemic attack.During the procedure, the patient complained of narrowed vision.It occurred about two hours since the procedure was started.Considering the possibility of thromboembolism, the procedure was discontinued when symptoms were confirmed.After consultation with a neurosurgeon, mri was performed.Catheter tip was checked after catheter removal, but no thrombus was found.In the medical examination by a neurosurgeon, there was no evidence of thromboembolism the result of mri showed no abnormality.The physician commented that catheters are unlikely to be the cause.The symptoms improved the next day.There were no abnormal findings in the mri of the brain.The physician suggested possible tension.The physician¿s opinion on the cause of this adverse event is that this is patient condition related.This adverse event was discovered during use of biosense webster products.Patient outcome of the adverse event was reported as improved.There is no further information about the hospitalization.

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) during an internal review on 09-nov-2021, the patient code of blurred vision (e083901) was removed since transient ischemic attack was already assigned and was reported on the 3500a initial medwatch report # mwr-26102021-0001067305.Please consider this code, blurred vision (e083901), as removed from field h6.Health effect - clinical code.

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab received the device for evaluation on (b)(6)2021.The device evaluation was completed on 22-nov-2021.It was reported that a 16-year-old male patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered a transient ischemic attack.During the procedure, the patient complained of narrowed vision.It occurred about two hours since the procedure was started.Considering the possibility of thromboembolism, the procedure was discontinued when symptoms were confirmed.After consultation with a neurosurgeon, mri was performed.Catheter tip was checked after catheter removal, but no thrombus was found.In the medical examination by a neurosurgeon, there was no evidence of thromboembolism the result of mri showed no abnormality.The physician commented that catheters are unlikely to be the cause.The symptoms improved the next day.There were no abnormal findings in the mri of the brain.The physician suggested possible tension.The physician¿s opinion on the cause of this adverse event is that this is patient condition related.This adverse event was discovered during use of biosense webster products.Patient outcome of the adverse event was reported as improved.There is no further information about the hospitalization.Device evaluation details: the device was returned to biosense webster inc.(bwi) for evaluation.Bwi conducted a visual inspection and an evaluation of all features of the catheter.Visual analysis of the returned device revealed that no damage or anomalies were observed on the thermocool® smart touch® sf bi-directional navigation catheter.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 30482462m number, and no internal actions related to the reported complaint condition were identified.All devices are manufactured, inspected, and released to approved specifications as part of bwi's quality process.No malfunction was observed during the product analysis.The instruction for use 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; 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: 12764869
• MDR Text Key: 280450669
• Report Number: 2029046-2021-01905
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2021

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: 30482462M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/13/2021
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 11/09/2021; 11/16/2021
• Supplement Dates FDA Received: 11/10/2021; 12/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2020
• 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
• Patient Outcome(s): Other
• Patient Age: 16 YR
• Patient Sex: Male