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 Cardiac Tamponade (2226); No Code Available (3191)

Event Date 08/18/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30376765m 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.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 patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.During left atrium (la) roof ablation, cardiac tamponade was confirmed.Pericardiocentesis was performed to drain an unspecified amount of fluid from the pericardial space.Patient¿s outcome is unknown.There¿s no indication that extended hospitalization was required.Physician¿s causality opinion was not provided.No biosense webster product malfunctions nor error messages were reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Since the event is life threatening and required medical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, then it is to be considered serious and mdr-reportable.

Manufacturer Narrative

On 10/5/2020, biosense webster inc.Received additional information about the patient and event.The patient was a 64-year-old male.Steam pop was not reported.No biosense webster product malfunctions nor error messages were reported.On 10/6/2020, additional information was received which indicated a pericardiocentesis was performed to drain an unspecified amount of fluid from the pericardial space; however, the fluid continued to accumulate in the pericardium, so the patient was transferred to the operating room and an open chest surgery was performed.It has been reported that the operation was successful and the patient had no problem.The physician¿s commented that when the cardiac tamponade (ct) was checked again, it was found that there was a diverticulum near the tamponade.They tried to ablate while checking impedance and contact force (cf) and set the impedance cut off to 35 ohms/0.5 seconds, changed to strict setting for impedance rise and continued to ablate.H6.Patient code 3191 (no code available) used to represent "surgical intervention".If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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; 33 technology drive; irvine CA 92618
• MDR Report Key: 10532663
• MDR Text Key: 206936618
• Report Number: 2029046-2020-01264
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/18/2020

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: 03/31/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30376765M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/14/2020
• Supplement Dates Manufacturer Received: 10/05/2020
• Supplement Dates FDA Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 64 YR