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

Model Number	80-1070
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with history of cad (coronary artery disease) and recent sob (shortness of breath).Procedure: heart cath, pci (percutaneous coronary intervention) of lad (left anterior descending artery).While inserting the sheath, it buckled and was not able to be used.Another glidesheath (slender 7fr) used.No known harm to patient, delay in procedure.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 CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 17236670
• Report Number: 17236670
• Device Sequence Number: 14891703
• Product Code: DYB
• UDI-Device Identifier: 00389701012087
• UDI-Public: (01)00389701012087(17)250501(10)0000285686
• 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): 06/26/2023
• Report Date (Section F): 06/26/2023

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: 80-1070
• Device Catalogue Number: 80-1070
• Device Lot Number: 0000285686
• 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: 06/30/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/30/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 133 KG
• Date Report Sent to FDA: 06/26/2023