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	03/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a routine left heart catheterization, the hemostatic valve leaked with a wire and catheter inserted.The patient was in stable condition.The estimated blood loss was less than 250cc's.The reported event did not result in patient injury and/or medical or surgical intervention.There is not 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 procedure.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A3b: gender: n/a.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: interventional cardiologist.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.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section d9, section h3, and to provide the completed investigation results.This reported event has been reassessed and deemed not reportable based upon the investigation of the actual sample.Based upon the inspection of the returned sample the reported event was reassessed and deemed not reportable.Inspection of the returned sample upon receipt found that the one 6fr ds sheath and dilator were returned for assessment.No visual abnormalities were seen on the sheath nor dilator.The sheath valve was subjected to leak testing without anything inserted in it and with the dilator inserted in it.The valve passed leak testing in both instances.The valve was disassembled and assessed.No damage was seen on the valve.The complaint cannot be confirmed for valve leakage because the sample passed leak testing.The exact root cause of the valve leakage experienced by the user could not be determined.The likely root cause of the leak during the procedure is that the catheter that was inserted into the valve was pressed down on the valve in such a way that the leaflets were held open, allowing some fluid to leak.No failure mode was detected on the returned device.Review of the 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).Therefore, this event is currently deemed a non-reportable event.

• 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: 18991634
• Report Number: 1118880-2024-00044
• Device Sequence Number: 12660192
• 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): 03/28/2024

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: 0000474561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2024
• Supplement Date Received by Manufacturer: 06/27/2024
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 07/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2024
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White