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 Problem Cardiac Tamponade (2226)

Event Date 11/22/2021

Event Type  Injury  

Manufacturer Narrative

(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 30612848l number, and no internal actions 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).

Event Description

It was reported that a female patient underwent a premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.It was reported that perforation at the anterior wall of the right ventricular outflow tract (rvot) occurred.The complaints occurred 60 minutes after entering, when right ventricle (rv) mapping/during ablation.The procedure administration discontinued because blood pressure decreased.Blood pressure rapidly decreased from the 130 s to the 40 s.Pericardial drainage was performed, and blood pressure recovered.The physician commented that there was a possibility that it hit the anterior wall when raising the thermocool® smart touch® sf bi-directional navigation catheter to the rvot.Additional information was received on the event.This adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event was procedure related.Drainage was performed.Patient outcome of the adverse event was improved.Prior to noting the cardiac tamponade, ablation was performed.There was no evidence of steam pop.The event occurred during ablation phase.No error messages observed on biosense webster equipment during the procedure.

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13014044
• MDR Text Key: 284025815
• Report Number: 2029046-2021-02195
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2021

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: 08/16/2022
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30612848L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/22/2021
• Initial Date FDA Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2021
• 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: PENTARAY NAV ECO 7FR, D, 2-6-2
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Female