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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Vascular Dissection (3160)

Event Date 01/06/2022

Event Type  Injury  

Event Description

It was reported that a male patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and a decanav electrophysiology catheter (decanav).And suffered vascular dissection requiring surgical intervention and prolonged hospitalization.It was reported that ablation was discontinued because aortic dissection was suspected.This occurred after 120 minutes since they entered, awhile after the catheter was delivered to the left ventricle via the aortic approach.The procedure was discontinued as a precaution.Since the patient complained of back pain during surgery, dissection was suspected.Echography and coronary angiography did not lead to a definitive diagnosis.The procedure was discontinued as a precaution.After discharge, a ct scan was performed, and the patient was diagnosed with aortic dissection.The physician commented that ¿i may have created a separation when we brought the catheter to the lv." additional information was received on 17-jan-2022.It was reported that the patient was under observation during hospitalization.As far as the treatment for aortic dissection, the patient underwent surgical operation.The biosense webster, inc.(bwi) products that come in direct contact with the vessel where the aortic dissection occurred were the thermocool® smart touch® sf bi-directional navigation catheter (stsf) and the decanav electrophysiology catheter (decanav).Additional information was received on 25-jan-2022.It was reported that the adverse event occurred on (b)(6) 2022.This adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event is that it is procedure related.The patient outcome of the adverse event is unchanged.

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.Biosense webster manufacturer's reference number (b)(4) has two reports: mfr # 2029046-2022-00192 for product code r7d282ct (decanav electrophysiology catheter).

Manufacturer Narrative

The device evaluation was completed on 02-mar-2022.It was reported that a male patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and a decanav electrophysiology catheter (decanav) and suffered vascular dissection requiring surgical intervention and prolonged hospitalization.It was reported that ablation was discontinued because aortic dissection was suspected.This occurred after 120 minutes since they entered, awhile after the catheter was delivered to the left ventricle via the aortic approach.The procedure was discontinued as a precaution.Since the patient complained of back pain during surgery, dissection was suspected.Echography and coronary angiography did not lead to a definitive diagnosis.The procedure was discontinued as a precaution.After discharge, a ct scan was performed, and the patient was diagnosed with aortic dissection.The physician commented that ¿i may have created a separation when we brought the catheter to the lv." device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation.Bwi conducted a general inspection through the visual inspection and all features of the catheter tests.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the thermocool® smart touch® sf bi-directional navigation catheter (stsf) 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 30648303l number, and no internal actions related to the complaint were found during the review.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Therefore, no capa activity is required.No malfunction was observed during the product analysis.The 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.Biosense webster manufacturer's reference number (b)(4).Has two reports: (1) mfr # 2029046-2022-00192 for product code r7d282ct (decanav electrophysiology catheter) (2), for product code d134805 (thermocool® smart touch® sf bi-directional navigation catheter).

Manufacturer Narrative

The biosense webster, inc.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.Biosense webster manufacturer's reference number (b)(4)has two reports: (1) mfr # 2029046-2022-00192 for product code r7d282ct (decanav electrophysiology catheter) (2) mfr # 2029046-2022-00191 for product code d134805.(thermocool® smart touch® sf bi-directional navigation catheter).

• 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: 13419729
• MDR Text Key: 288988043
• Report Number: 2029046-2022-00191
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: 03/27/2022

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: 09/26/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30648303L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/06/2022
• Initial Date FDA Received: 02/01/2022
• Supplement Dates Manufacturer Received: 02/03/2022; 03/02/2022
• Supplement Dates FDA Received: 03/02/2022; 03/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2021
• 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: 7FR DECAN,11P,D,2.4MMLE,282MM,; SOUNDSTAR ECO SMS 8F CATHETER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Sex: Male