MAUDE Adverse Event Report: BIOSENSE WEBSTER; PENTA RAY MAPPING CATHETER

Catalog Number D128208

Device Problem Gas/Air Leak (2946)

Patient Problem Air Embolism (1697)

Event Date 09/13/2019

Event Type  Injury  

Event Description

During procedure ekg changes noted, air embolus in coronary arteries; pt underwent cardiac cath.Fluid infusing per pressure bag device with air bubbles noted in line post procedure.

• Brand Name: BIOSENSE WEBSTER
• Type of Device: PENTA RAY MAPPING CATHETER
• MDR Report Key: 9397167
• MDR Text Key: 168813062
• Report Number: 9397167
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2022
• Device Catalogue Number: D128208
• Device Lot Number: 30242586L
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 09/13/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/02/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 57