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 Cardiac Tamponade (2226); Vascular Dissection (3160)

Event Date 11/26/2021

Event Type  Injury  

Manufacturer Narrative

Device investigation details: 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 30604458l number, and no internal action related to the complaint was found during the review.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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 ref.# (b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered cardiac tamponade and vascular dissection of the coronary sinus (cs).The doctor attempted to deliver an ablation catheter to ablate from within the cs.At that time, the cs was broken by the ablation catheter, resulting in cardiac tamponade.Blood pressure (bp) decreased to his 50s, and pericardial effusion was confirmed by echocardiography.A small amount of pericardium was confirmed.Drainage was not performed at the discretion of the physician, and treatment was completed with protamine reverse.Drainage was not performed at the discretion of the physician.The doctor instructed not to drain.Treatment was completed with protamine reverse.Protamine is administered with reference to the value of act immediately before).The patient returned to the intensive care unit (icu).The physician commented that it was not a product defect, but cs was torn at the time of cs insertion and might have been strongly hit at the time of cs insertion.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 was procedure related.

• 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: 13025125
• MDR Text Key: 285964077
• Report Number: 2029046-2021-02210
• 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
• Report Date: 12/17/2021

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: 09/01/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30604458L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/26/2021
• Initial Date FDA Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2021
• 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
• Patient Outcome(s): Required Intervention; Life Threatening