MAUDE Adverse Event Report: A&E MEDICAL CORPORATION UFM W 16MM 3/8CIR 64MM KN 24PK; ELECTRODE, PACEMAKER, TEMPORARY

Model Number N/A

Device Problems Fracture (1260); Material Frayed (1262); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/03/2023

Event Type  malfunction  

Manufacturer Narrative

Zimmer biomet complaint (b)(4).D2: device product code: ldh.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

It is reported that the patient underwent a cardiac procedure.The metal end of one of the ventricular pacing wires fell off.The ventricular lead fractured prior to a code/ecmo eve.Patient code was not related to fractured wire.Nurse stated the ventricular wire was for backup purposes.Ventricular wire is stripped but not repaired at this time and patient does have atrial wires.The ventricular wire placed first, and the atrial wire was replaced about two month later.Attempts have been made and additional information on the reported event is unavailable at this time.

Event Description

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

Manufacturer Narrative

This report is being submitted to update additional information in section b4, b5, g3, g6, h2, h4, h6 and h10.Corrections are in sections: a1, a2, a3, a4, e1, and e3.A4: patient weight: (b)(6)(b)(6)2023.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D2: device product code: ldf.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 cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.This report is being submitted to update additional information in section.

Event Description

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

Manufacturer Narrative

This report is being submitted to update additional information in section b4, b5, d4, e4, g2, g3, g6, h2, h3, h4, h6 and h10.

Event Description

It is further reported that the wires fray and break away from the metal contacts.Pacing and capture fail.The wires are fragile.The fraying is taking place with in three days of use.

Manufacturer Narrative

This follow-up report is being submitted to relay additional information.D2: device product code: ldf review of the device history records identified no deviations or anomalies during manufacturing.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.

Event Description

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

Event Description

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

• Brand Name: UFM W 16MM 3/8CIR 64MM KN 24PK
• 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: 17278256
• MDR Text Key: 318573124
• Report Number: 0002242056-2023-00020
• Device Sequence Number: 1
• Product Code: JEY
• UDI-Device Identifier: 10841291100263
• UDI-Public: (01)10841291100263(10)03363(17)271001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K803086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/16/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 024-311
• Device Lot Number: 03363
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2022
• 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): Required Intervention
• Patient Age: 2 MO
• Patient Sex: Male
• Patient Weight: 3 KG