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

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the valve of the involved glidesheath slender was leaking the entire case during a left heart cath and intervention.The event occurred intra-operative.The blood loss was less than 250cc's.The reported event did not result in patient injury and/or require medical intervention or surgical intervention.There is a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.Additional information was received on 07 mar 2024: no sheaths were exchanged during the procedures.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A3b: gender: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: lead tech.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.One 6 french glide sheath slender (gss) sheath was returned for assessment.The components were visually examined.No visual abnormalities were observed on the sheath.The sheath valve was subjected to leak testing without anything inserted in it and with a dilator inserted in it.The valve failed leak testing in the first instance.The valve was then deconstructed and examined.An off-center tear was visible on the valve.The complaint can be confirmed for valve leakage due to the sample failing leak testing.Based on the location of the tear on the valve, the leakage was likely caused by off-center insertion of the dilator in the valve.Review of device history record (dhr) showed there were no issues noted during manufacture of the product that could have contributed to this complaint condition.Currently no action is recommended since this risk evaluation is within the predetermined limits in the design failure mode and effects analysis (dfmea).

• 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: gina digioia ; 950 elkton blvd; elkton, MD 21921 ; 4103927218
• MDR Report Key: 19096710
• Report Number: 1118880-2024-00045
• Device Sequence Number: 18076959
• Product Code: DYB
• UDI-Device Identifier: 00389701011332
• UDI-Public: 00389701011332
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2024

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 Expiration Date: 07/01/2026
• Device Model Number: N/A
• Device Catalogue Number: 50-1060
• Device Lot Number: 0000485244
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2024
• 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: 80 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White