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

Model Number	80-1060
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: expiration date: unknown, as the involved lot # was not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.H4: device manufacture date: unknown, as the involved lot # was not provided.The production lot # was not provided by the user facility, which prevented a meaningful review of the device history record.The actual device is not available for return; therefore, an evaluation of the device could not be conducted.The complaint cannot be confirmed for valve leakage as the sample was not provided 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 is no indication that any manufacturing issues may have led to this event.Currently no action is recommended since this risk evaluation is within the predetermined limits in the hazard based risk table (hbrt).
Event or Problem Description
The user facility reported that the sheath was leaking blood during a heart catheterization procedure.The blood loss was greater than 250 cc.The reported event did not result in patient injury or require medical or surgical intervention.Additional information received on 12 mar 2025: the procedure was a heart catheterization.There was no noticeable damage to the device, but it was leaking from the valve.The procedure was successful.Additional information received on 17 mar 2025: the patient is stable.It cannot be confirmed if the blood loss was greater than 250 cc or if the doctor used another sheath.Additional information received on 31 mar 2025: the blood loss was less than 250 cc.

• 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: 21774382
• Report Number: 1118880-2025-00049
• Device Sequence Number: 15473633
• Product Code: DYB
• UDI-Device Identifier: 00389701012063
• UDI-Public: 00389701012063
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/04/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown