MAUDE Adverse Event Report: JOHNSON & JOHNSON / BIOSENSE WEBSTER (ISRAEL), LTD. BIOSENSE WEBSTER CARTO; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number FG540000

Device Problems Application Program Problem (2880); Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 12/17/2021

Event Type  malfunction  

Event Description

During cardiac ablation, the mapping system went down.The catheter and the handle were both replaced a couple times but was still not working properly.The case was aborted and it was found that the system needed a software update.This update was completed following the case.Fda safety report id# (b)(4).

• Brand Name: BIOSENSE WEBSTER CARTO
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): JOHNSON & JOHNSON / BIOSENSE WEBSTER (ISRAEL), LTD.
• MDR Report Key: 13118659
• MDR Text Key: 283139475
• Report Number: MW5106382
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG540000
• Device Catalogue Number: FG-5400-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 109 KG