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

Model Number	80-1060
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
Terumo medical received an fda medwatch report # mw5164171.The event description states that "blood was leaking out the port' on the access side of the sheath (the part that remains outside of the patient).This is supposed to be a one-way valve to prevent blood from leaking out of the sheath." additional information was received on 21 jan 2025: the patient's condition was stable.The blood leakage was minimal, less than 10 ml, so it was less than 250 ml.The procedure taking place at the time the blood leakage occurred was cardiac catheterization.To resolve the issue and continue the procedure, a new sheath was obtained.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint can be confirmed for valve leakage.The exact root cause cannot be determined.The likely cause is off-centered insertion of the dilator into the sheath, causing a tear in the valve.Review of device history record showed there were no issues noted during the manufacture of the product that could not have contributed to this complaint condition.Currently, no action is recommended since this risk evaluation is within the predetermined limits of the hazard based risk table (hbrt).

• 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: 21392591
• Report Number: 1118880-2025-00006
• Device Sequence Number: 20981231
• Product Code: DYB
• UDI-Device Identifier: 00389701012063
• UDI-Public: (01)00389701012063(17)270201(10)0000662655
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2025

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
• Device Lot Number: 0000662655
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2025
• Supplement Date Received by Manufacturer: 03/19/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2024
• 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 Age: 63 YR
• Patient Sex: Female
• Patient Weight: 164 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White