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 Problems Hematoma (1884); Cardiac Tamponade (2226)

Event Date 03/10/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number 30694430l and no internal action related to the complaint was found during the review.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 ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a cardiac tamponade/ hematoma (apex of the heart) and required prolonged hospitalization.Decreased blood pressure was confirmed during the waiting time after ablation.A ct scan is confirmed the hematoma.After ablation it was at the apex site of the heart.This hematoma is considered cardiac tamponade.The physician commented that no causality.This adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event was it not related with the bwi product.No intervention was provided.The patient outcome was fully recovered.The patient required extended hospitalization because of the adverse event.A transseptal puncture was performed with a rf needle was used.Before noticing the cardiac tamponade, ablation was performed and there was no evidence of a steam pop.Force visualization features used were real time graph, dashboard, vector and visitag with the additional filter of fot and tag index.The hematoma was part of the late apex of the heart.

Manufacturer Narrative

Additional information was received on the event on 06-may-2022.The event occurred after the ablation phase.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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 13992697
• MDR Text Key: 289534847
• Report Number: 2029046-2022-00712
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/26/2022

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: 01/03/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30694430L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 04/04/2022
• Supplement Dates Manufacturer Received: 05/06/2022
• Supplement Dates FDA Received: 05/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2022
• 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: UNKNOWN BRAND RF NEEDLE; UNK_CARTO 3
• Patient Outcome(s): Life Threatening; Hospitalization
• Patient Sex: Female