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

Model Number	60-1060
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Event or Problem Description
Terumo medical received the following information.The guidewire would not pass through the inner dilator.The event occurred pre-operatively.
Additional Manufacturer Narrative
E3: occupation: supply chain the actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The sample was not returned for investigation; however, there is a known issue with this lot number of glidesheath slender devices concerning the incorrect size guidewire provided in the packaging.This issue has been confirmed in investigations with returned samples from the same lot.Therefore, the complaint will be confirmed for a packaging issue based on the investigations of similar samples.The root cause is the incorrect guidewire was included in the components during the packaging process.A corrective action has been implemented for this issue.The device history record review determined the process was performed and completed in accordance with terumo medical corporation specifications and procedures.Res 99285 has been provided as the z# has not been assigned at this time.

• 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: 25710825
• Report Number: 1118880-2026-00406
• Device Sequence Number: 14737821
• Product Code: DYB
• UDI-Device Identifier: 00389701011974
• UDI-Public: (01)00389701011974(17)280501(10)0001441871
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 07/04/2026

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: 60-1060
• Device Catalogue Number: 60-1060
• Device Lot Number: 0001441871
• 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: 06/16/2026
• Initial Report FDA Received Date: 07/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/03/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 99285
• Patient Sequence Number: 1
• Patient Sex: Unknown