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

Model Number D134805

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Ventricular Fibrillation (2130); Cardiac Tamponade (2226); No Code Available (3191)

Event Type  Death  

Manufacturer Narrative

(b)(6).(b)(4).Reported was the event year only of 2020.Multiple attempts have been made to obtain clarification to the event month and day.However, no further information has been made available.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 30419633l number, 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.(b)(4).

Event Description

It was reported that a male patient (b)(6) year old) underwent cardiac ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter and suffered ventricular fibrillation requiring cardioversion, cardiac tamponade requiring surgical intervention and death.During procedure the patient developed ventricular fibrillation (vf) shortly after the beginning of ablation.Cardioversion was performed to stop vf and just after the physician noticed dissociation.Ultrasound showed pericardial effusion.Pericardiocentesis was performed and the patient was transferred to repair surgery.During surgery pericardial effusion was confirmed due to left aria wound (find by a surgeon after thoracotomy) and the patient did not survive the surgery and expired.There was no report of product malfunction.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; 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 drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10692056
• MDR Text Key: 211733656
• Report Number: 2029046-2020-01499
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30419633L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/21/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/11/2020
• 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): Death; Required Intervention
• Patient Age: 82 YR