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

Model Number	80-1060
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of unstable angina.Procedure: heart catheterization.The tip if the sheath's dilator is closed off.Unable to use on patient.Another dilator used without problem.

• Brand Name: GLIDESHEATH SLENDER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORP; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 19031146
• Report Number: 19031146
• Device Sequence Number: 12523108
• Product Code: DYB
• UDI-Device Identifier: 00389701012063
• UDI-Public: (01)00389701012063(17)260601(10)0000471240
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/13/2024
• Report Date (Section F): 03/13/2024

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: 80-1060
• Device Catalogue Number: 80-1060
• Device Lot Number: 0000471240
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/03/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/03/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 2 MO
• Patient Sex: Male
• Date Report Sent to FDA: 03/13/2024