MAUDE Adverse Event Report: A&E MEDICAL CORPORATION MYO/WIRE UFM W 89MM KN; ELECTRODE, PACEMAKER, TEMPORARY

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 12/08/2023

Event Type  Injury  

Event Description

It was reported that the temporary pacing wire was placed on the atrium as per usual for cardiac patients.However, the surgeon decided to change the position of the wire, and consequently the wire did not pull away from the surface of the heart easily.This caused a small tear in the atrium.As the patient's chest was still open, the surgeon was able to repair the hole with a prolene suture.Attempts have been made and additional information on the reported event is unavailable at this time.

Manufacturer Narrative

Zimmer biomet complaint (b)(4).D2: devoce product code: ldf g3: foreign source: australia the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.

Event Description

No further event information is available at the time of this report.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.The reported event is unconfirmed.If any further information is found that would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: MYO/WIRE UFM W 89MM KN
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer (Section G): A&E MEDICAL CORPORATION; 5206 asbury road; farmingdale NJ 07727
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 18450542
• MDR Text Key: 332173099
• Report Number: 0002242056-2023-00035
• Device Sequence Number: 1
• Product Code: JEY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K803086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 021-001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/12/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention