MAUDE Adverse Event Report: BIOSENSE WEBSTER (ISRAEL) LTD. CARTO 3; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Model Number FG540000

Device Problem Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 04/13/2023

Event Type  malfunction  

Event Description

During an atrial fibrillation ablation procedure and mapping of the left atrium, there was a failure of ecg 1 in the piu of the carto mapping system causing a delay and switch to a portable system.Manufacturer response for mapping system, carto 3 system (per site reporter).Device was repaired.(b)(4).Findings: defective part - backplane card.Defective cable - bodysurface electrograms.Defective part - ecg card.

• Brand Name: CARTO 3
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER (ISRAEL) LTD.; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 17057292
• MDR Text Key: 316491765
• Report Number: 17057292
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: FG540000
• Device Catalogue Number: FG-5400-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/23/2023
• Event Location: Hospital
• Date Report to Manufacturer: 06/05/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 28835 DA
• Patient Sex: Female