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	04/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Procedure: elective percutaneous transluminal coronary angioplasty.The sidewall on the sheath split and the wire went through.No known harm to patient, another one use.Manufacturer response for introducer, catheter, glidesheath slender (per site reporter), will obtain.

• Brand Name: GLIDESHEATH SLENDER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORP.; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 19380444
• Report Number: 19380444
• Device Sequence Number: 18047124
• Product Code: DYB
• UDI-Device Identifier: 00389701012063
• UDI-Public: (01)00389701012063(17)260801(10)0000533023
• 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): 05/03/2024
• Report Date (Section F): 05/03/2024

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: 0000533023
• 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: 05/23/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/23/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 1 MO
• Patient Sex: Male
• Date Report Sent to FDA: 05/03/2024