MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION GLIDESHEATH; INTRODUCER, CATHETER

Model Number	50-1060
Medical Device Problem Codes	Material Separation (1562); Unraveled Material (1664)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A4: weight: requested, not provided d6a: implanted date: device was not implanted d6b: explanted date: device was not explanted e3: occupation: cath lab manager.A review of the device history record of the product code/lot number combination was conducted with no findings.The complaint cannot be confirmed for guidewire separation as the sample was not returned for investigation.Without a sample, the exact root cause cannot be determined.The device history record review determined the device was in a conforming state when released from terumo control.There is no indication that any manufacturing issues may have led to this event.Currently no action is recommended since this risk evaluation is within the predetermined limits in the hazard based risk table (hbrt).
Event or Problem Description
Terumo medical corporation received the reported information.When the doctor was gaining access with the glidesheath slender and while manipulating the wire he attempted to pull it out of the wire and the wire came unraveled.The wire was removed and there was no patient complication.There was no blood loss.The procedure being performed was radial heart catheterization.Additional information was received on 13oct2025: when the doctor was gaining access with the device, he attempted to remove wire through the needle.The wire became unraveled, and at that time separated from the wire.It was not known at the time if the tip of the wire was left in the patient.Two days later in the intensive care unit (icu), the patient developed a sore at the entry site.The doctor cleaned the site and noticed the wire protruding through skin and was able to remove the wire.The wire removed was about 19mm.The patient was fine and had no other complications.

• Brand Name: GLIDESHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 23416411
• Report Number: 1118880-2025-00155
• Device Sequence Number: 21399800
• Product Code: DYB
• UDI-Device Identifier: 00389701011332
• UDI-Public: (01)00389701011332(17)270901(10)0001023042
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/29/2025

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 Model Number: 50-1060
• Device Catalogue Number: 50-1060
• Device Lot Number: 0001023042
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2025
• 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; Required Intervention
• Patient Age: 88 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American