MAUDE Adverse Event Report: C. R. BARD TEMPORARY PACING ELECTRODE CATHETER; PACING WIRE

Model Number BIPOLAR BALLOON

Device Problem Malposition of Device (2616)

Patient Problems Death (1802); Increased Sensitivity (2065); Cardiac Tamponade (2226)

Event Date 07/23/2019

Event Type  Death  

Event Description

Pt undergoing tavr, temporary pacing catheter placed and pt began to deteriorate.Echo performed, large pericardial effusion.Pericardial window performed in cath lab, pt to ccu.

• Brand Name: TEMPORARY PACING ELECTRODE CATHETER
• Type of Device: PACING WIRE
• Manufacturer (Section D): C. R. BARD; covington GA 30014
• MDR Report Key: 8896499
• MDR Text Key: 154546420
• Report Number: 8896499
• Device Sequence Number: 1
• Product Code: LDF
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: BIPOLAR BALLOON
• Device Catalogue Number: 106173P
• Device Lot Number: GFDRO478
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/23/2019
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 95