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

Model Number	50-1060
Medical Device Problem Codes	Break (1069); Unraveled Material (1664)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical received a user facility medwatch report # (b)(4).The medwatch event description stated that: "patient was brought to cardiac cath lab for radial approach angiogram.After radial artery access the wire was inserted and then an attempt was made to remove the wire and the needle.It was noticed that the wire unraveled and approximately 1.5cm broke off in the patient's skin and into the radial artery.What was the original intended procedure? heart catheterization with possible pci.What problem did the user have: device failed (e.G.Broke, couldn't get it to work or stopped working); preexisting characteristics that may have contributed to the event: coronary heart disease; diabetes; hypertension." terumo medical corporation received the following reported information: the broken wire was retrieved from the patient by vascular surgery.Palpable radial pulse post-procedure was performed to confirm the wire was retrieved.The wire broke during the attempt of the removal of wire and needle.The patient was stable.
Additional Manufacturer Narrative
E3: occupation: patient safety manager | risk management.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.As of 15may2026, the sample has not been returned for investigation.The complaint will be completed with all available information.Should the sample be returned in the future, the complaint will be reopened and updated.The complaint cannot be confirmed for guidewire mechanical 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 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: 24845308
• Report Number: 1118880-2026-00098
• Device Sequence Number: 21039109
• Product Code: DYB
• UDI-Device Identifier: 00389701011332
• UDI-Public: (01)00389701011332(17)280401(10)0001371014
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/10/2026

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: 0001371014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Supplement Date Received by Manufacturer: 05/21/2026; 06/30/2026
• Initial Report FDA Received Date: 04/10/2026
• Supplement Report FDA Received Date: 05/22/2026; 07/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2025
• 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: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 167 LB
• Patient Race: White