MAUDE Adverse Event Report: MICROTEK MEDICAL LLC MICROTEK; PACEMAKER DRP 86X135IN W-FENS

Model Number	PD201
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a foreign object, glass fragment, was embedded in the rear section of the microtek pacemaker drape (ref #pd201, lot 4364lro000).During the draping process in the catheterization laboratory (cath lab), the fragment made contact with a radiation technician.The glass was partially protruding from the fabric and caused a poke to the technician.However, the contact did not result in skin penetration, laceration, or any reportable injury.The incident was promptly documented by the reporter, and photographic evidence was collected to support the complaint.No patient contact occurred, and there were no reported infections, complications, or adverse clinical outcomes associated with the event.The manufacturer conducted an investigation but was unable to determine the origin of the foreign material.No root cause was identified.

• Brand Name: MICROTEK
• Common Device Name: PACEMAKER DRP 86X135IN W-FENS
• Manufacturer (Section D): MICROTEK MEDICAL LLC; three lakes drive; northfield IL 60093
• Manufacturer (Section G): MICROTEK DOMINICANA S.A; zona franca no. 2; la romana, la romana 22000 ; DR 22000
• Manufacturer Contact: yarina montas ; three lakes drive; northfield, IL 60093
• MDR Report Key: 22749005
• Report Number: 8043817-2025-00004
• Device Sequence Number: 8598837
• Product Code: PUI
• UDI-Device Identifier: 00748426066896
• UDI-Public: 00748426066896
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 08/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PD201
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown