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

Model Number	50-1060
Medical Device Problem Codes	Material Frayed (1262); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: manager cath lab.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
Terumo received the following reported information: during a radial catheter procedure, the 6 french glidesheath slender wire frayed in the patient's arm; however, the wire did not break off inside the arm and did not require surgical intervention.Fluoroscopy was performed to ensure the wire was removed from the patient's arm.The wire came out like fine hair, then continued to unravel.The sheath was used; however, a different needle and wire was used.The patient was stable; no harm was caused.The blood loss was negligible.There was no damage noticed to the device prior to use.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3, and to provide the complete investigation results.One guidewire and package for a 6 french glidesheath slender device was returned for product evaluation.The device was subjected to visual analysis.The guidewire appears to be used with visible signs of blood.The tip of the guidewire center rod is detached from the rest.The outer coiling is unraveled.The returned guidewire had the outer coiling unraveled from the core.Therefore, the complaint can be confirmed for guidewire mechanical separate/break.The exact root cause cannot be determined.The likely cause is the guidewire was pulled through the needle, nicking the outer coiling and causing it to unravel.This cannot be confirmed based on the provided information.The device history record review determined the device was in a conforming state when released from terumo control.There are no indications manufacturing issues may have led to this event.No action is recommended since this risk evaluation is within the predetermined limits.

• Brand Name: GLIDESHEATH SLENDER
• 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: 24443281
• Report Number: 1118880-2026-00013
• Device Sequence Number: 10254971
• Product Code: DYB
• UDI-Device Identifier: 00389701011332
• UDI-Public: (01)00389701011332(17)280301(10)0001287826
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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
• Operator of Device: Health Professional
• Device Model Number: 50-1060
• Device Catalogue Number: 50-1060
• Device Lot Number: 0001287826
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 02/25/2026
• Supplement Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2025
• 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
• Patient Sex: Unknown