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

Model Number	N/A
Medical Device Problem Codes	Leak/Splash (1354); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the sheath was hard to aspirate.The doctor advanced the sheath with the dilator, then tried to aspirate the sheath; however, nothing came through the sheath.The case was completed successfully, and the patient left the room in stable condition.No blood loss was reported.The patient was not injured during the event and medical/surgical intervention was not needed.There is no direct claim that the reported device caused or contributed to a patient injury or the need for medical intervention.Additional information was received on 05jun2024: the procedure performed was a left brachial vein access for a lue venogram and left subclavian percutaneous transluminal angioplasty (pta).The sheath was not aspirating every time.Sometimes it would aspirate a little bit and the doctor could still inject contrast through the sheath for the images.During the case it did not 100% aspirate correctly.The only thing in the sheath was the catheter a few times for the injection of contrast and the other times it was just the sheath itself when it was having a hard time flushing through.The doctor would put the dilator back in to make sure it was opened all the way.After the removal of the sheath, it showed no visible issues with the sheath.Additional information was received on 05jun2024: they event occurred when they attempted to aspirate from the stopcock on the side arm.
Additional Manufacturer Narrative
A3b: gender: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.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 sent as follow-up no.1 to update 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.Inspection of the returned sample upon receipt found that one 6fr gss sheath with its dilator fully mated was returned for assessment.No abnormalities were observed along the length of sheath, dilator 3wsc, nor side tube.Water was attempted to be aspirated through the sheath, and was able to pass easily through the sheath, side tube, and 3wsc pathway.The complaint cannot be confirmed for fluid issues because the sample was able to aspirate without difficulty.The exact root cause of the fluid issue experienced by the user could not be determined.The likely root cause is that there was something blocking the tip of the sheath during aspiration such as the posterior wall, fibrin deposition, etc.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: 19583568
• Report Number: 1118880-2024-00092
• Device Sequence Number: 14329255
• Product Code: DYB
• UDI-Device Identifier: 00389701012063
• UDI-Public: 00389701012063
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2024

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: 09/01/2026
• Device Model Number: N/A
• Device Catalogue Number: 80-1060
• Device Lot Number: 0000537579
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2024
• Supplement Date Received by Manufacturer: 07/15/2024
• Initial Report FDA Received Date: 06/21/2024
• Supplement Report FDA Received Date: 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2024
• 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: 17 YR
• Patient Sex: Female
• Patient Weight: 147 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White