MAUDE Adverse Event Report: BIOSENSE WEBSTER 8MM FLTR CATHETER

Device Problem Insufficient Information (3190)

Patient Problem Full thickness (Third Degree) Burn (2696)

Event Date 03/27/2014

Event Type  Injury  

Event Description

An ablation of typical atrial flutter was performed using the biosensewebster fltr 8mm catheter, stockert 70 rf generator, and covidien grounding pad; impedance characteristics and feedback data from the catheter were unremarkable during the procedure.Following the conclusion of the procedure, the pt was discovered to have sustained a severe full thickness skin burn penetrating into subcutaneous fat at the site of the grounding pad.Alarm behavior and connection to the grounding pad were unremarkable during the procedure.

• Brand Name: 8MM FLTR CATHETER
• Type of Device: 8MM FLTR CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER
• MDR Report Key: 3724084
• MDR Text Key: 16803855
• Report Number: MW5035412
• Device Sequence Number: 1
• Product Code: DRF
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/28/2014
• 3 Devices were Involved in the Event: 1 2 3

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/31/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 74 YR
• Patient Weight: 105