MAUDE Adverse Event Report: A&E MEDICAL CORPORATION MYO/WIRE ULTRA-THIN TEMPORARY PACING WIRES; ELECTRODE, PACEMAKER, TEMPORARY

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	06/17/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a cardiac patient had temporary pacing wires placed in the operating room post-operatively.Later at night it was discovered that the pacing wire had frayed and pierced through the heart wall.The patient is currently in stable condition.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).G2: foreign - canada customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d4; g3; g6; h1; h2; h3; h6; h11.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: MYO/WIRE ULTRA-THIN TEMPORARY PACING WIRES
• Common Device Name: 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: 19819774
• Report Number: 0002242056-2024-00017
• Device Sequence Number: 21006327
• Product Code: LDF
• UDI-Device Identifier: 08718627412527
• UDI-Public: (01)08718627412527(10)260101
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K033858
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/25/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2026
• Device Model Number: N/A
• Device Catalogue Number: BMZF605ACBBG
• Device Lot Number: 16295
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 07/24/2024
• Supplement Report FDA Received Date: 11/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown