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

Model Number	80-1060
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly female with coronary artery disease, and recent chest discomfort, and shortness of breath.Procedure: right heart catheterization.When the terumo glidesheath slender 6 fr.Removed from package, there was a large bend in the wire midway.Not used on patient.

• Brand Name: GLIDESHEATH SLENDER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 18551468
• Report Number: 18551468
• Device Sequence Number: 7597506
• Product Code: DYB
• UDI-Device Identifier: 00389701012063
• UDI-Public: (01)00389701012063(17)260401(10)0000438021
• 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): 01/09/2024
• Report Date (Section F): 01/09/2024

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
• Operator of Device: Health Professional
• Device Model Number: 80-1060
• Device Catalogue Number: 80-1060
• Device Lot Number: 0000438021
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 01/09/2024