MAUDE Adverse Event Report: BIOSENSE WEBSTER BIOSENSE CARTO 3 SYSTEM

Model Number CARTO 3 SYSTEM

Device Problem Device Inoperable (1663)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/23/2016

Event Type  Injury  

Event Description

During a cardiac ablation procedure, the biosense carto 3 system mapping system malfunctioned causing the surgical procedure to be aborted prior to its completion.Diagnosis or reason for use: directs the surgeon where to go.Is the product compounded: no.Is the product over-the-counter: no.Event abated after use stopped or dose reduced: yes.

• Brand Name: BIOSENSE CARTO 3 SYSTEM
• Type of Device: BIOSENSE CARTO 3 SYSTEM
• Manufacturer (Section D): BIOSENSE WEBSTER; diamond bar CA 91765
• MDR Report Key: 5962894
• MDR Text Key: 55256458
• Report Number: MW5064848
• Device Sequence Number: 1
• Product Code: DRQ
• UDI-Device Identifier: 1237723342
• UDI-Public: 1-237723342
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CARTO 3 SYSTEM
• Device Lot Number: 13457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2016
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization