MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RELIANCE 4-FRONT; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)

Model Number 0672

Device Problems Failure to Capture (1081); Positioning Problem (3009)

Patient Problem Cardiac Arrest (1762)

Event Date 04/13/2023

Event Type  Injury  

Event Description

It was reported that this patient underwent a coronary artery graft procedure, and a few days later a procedure to implant an implantable cardioverter defibrillator (icd) was attempted.Temporary pacing wires and a temporary external pacemaker were utilized.The device pocket was created, and the subclavian vein was accessed with a stylet.The physician experienced difficulty accessing the right ventricle (rv), and despite efforts to re-shape the stylet, it could not be placed into the lead and a second stylet was presented.The physician still had an unused firm and a soft stylet but the boston scientific sales representative who was present at the procedure went to the stock room to obtain additional stylets for back up use.The representative returned with the stylets and observed that the lead was not in the rv and the patient was in cardiac arrest.The lead was placed in the rv and connected to the pacing system analyzer (psa) cables.Pacing spikes were observed on the electrograms which correlated with the psa; however, capture was unsuccessful despite maximum outputs.External pacing was unsuccessful and cardiac massage was required.The patient was put on a bypass machine and then an extracorporeal membrane oxygenation (ecmo) machine and transferred back to the intensive care unit.No additional adverse patient effects were reported.

Manufacturer Narrative

As no further information concerning this report is expected, our investigation is complete.This investigation will be updated should further information be provided.

• Brand Name: RELIANCE 4-FRONT
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT)
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 16772544
• MDR Text Key: 313610253
• Report Number: 2124215-2023-18720
• Device Sequence Number: 1
• Product Code: LWS
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 0672
• Device Catalogue Number: 0672
• Device Lot Number: 206469
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other; Life Threatening; Hospitalization