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 underwent tavr, temporary pacing catheter placed and tavr completed.Pacing wire removed at end of case.Pt began to deteriorate in recovery room.Echo obtain with finding of pericardial effusion.Pt continued to deteriorate, taken to surgery for pericardial window, pt continued to deteriorate and removed to cath lab for temporary pacing, full code and pt expired.

• Brand Name: TEMPORARY PACING ELECTRODE CATHETER
• Type of Device: PACING WIRE
• Manufacturer (Section D): C. R. BARD. ; covington GA 30014
• MDR Report Key: 8896507
• MDR Text Key: 154546423
• Report Number: 8896507
• 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: 04/23/2019
• 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: 82 YR
• Patient Weight: 73