MAUDE Adverse Event Report: C. R. BARD, INC. GOETZ TEMPORARY PACING ELECTRODE CATHETER; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 007157P

Device Problem Insufficient Information (3190)

Patient Problems Chest Pain (1776); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Tachycardia (2095); Rupture (2208); Cardiac Tamponade (2226); Loss of consciousness (2418); Pericardial Effusion (3271)

Event Date 06/14/2021

Event Type  Injury  

Event Description

St-segment elevation myocardial infarction (stemi) status post (s/p) cardiac arrest and recent tamponade from right ventricular (rv) free wall rupture from tv pacing wire.Around noon, patient was speaking with doctor when she became more somnolent.She was noted to be hypotensive to 60s/40s.As she was bolused with 1l lr and restarted on levophed, she was noted to lose consciousness for a minute and was bag ventilated then reawakened.Cardiac remained sinus.Levophed was titrated up to 0.6 to maintain bp.On point of care echo, patient was found to have a pericardial effusion with fluid anterior to the rv c/f rv wall rupture vs.Other tear measuring 1.5 cm in deepest pocket.Patient then had stat limited echo showing pericardial effusion.Patient had tamponade physiology and became more tachycardic with hypotension and pulsus seen on a line.Stabilized to systolic blood pressure (sbp) in the 90s, diastolic blood pressure (dbp) 50s per a line and a line was rewired at bedside.Pt was maintained on levophed 0.6 with continuous infusion of lr bolus.Patient remained conscious, was able to consent for surgery.Point of care labs notable for ph 7.1 with lactate>60.Patient was redlined to the operating room with ct surgery for pericardial window vs right ventricular (rv) repair.Prior to transfer to or, patient complained of 5/10 chest pressure and shortness of breath (sob).

• Brand Name: GOETZ TEMPORARY PACING ELECTRODE CATHETER
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): C. R. BARD, INC.; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 12098894
• MDR Text Key: 259373419
• Report Number: 12098894
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 007157P
• Device Catalogue Number: 007157P
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 24820 DA
• Patient Weight: 96