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

Model Number	80-1060
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the introducer wire would not pass through the needle.They had to re-stick to start the case.There was no patient injury.Additional information was received on 07jan2025: the patient was in stable condition.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted , d6b: explanted date: device was not explanted, e3: occupation: lab manager.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.One 6fr gss was returned to terumo medical corporation for product evaluation.The returned sample included the tray, guidewire, needle and the shelfpack.The returned sample was visually inspected, and the guidewire was found to be kinked.No other signs of damage were observed.Functional testing was performed, and the wire was attempted to be inserted into the needle.The wire was successfully inserted through the needle with no resistance.The complaint cannot be confirmed for needle and guidewire mobility since the device functioned as expected.However, the complaint can be confirmed for guidewire kink.The exact root cause cannot be confirmed.The likely root cause is the needle was clogged by unknown object that may have dislodged during shipment, or the needle was inserted too far into the vessel and the guidewire met the vessel wall.The device history record (dhr) review determined that 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 failure mode and effects analysis (fmea).

• 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: 21124537
• Report Number: 1118880-2024-00180
• Device Sequence Number: 8733091
• Product Code: DYB
• UDI-Device Identifier: 00389701012063
• UDI-Public: (01)00389701012063(17)270101(10)0000640425
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

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: 0000640425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2024
• Supplement Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2024
• 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 Sex: Unknown