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

Model Number	80-1060
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E3: occupation: doctor of osteopathic medicine (do) 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.
Event or Problem Description
The user facility reported that the medical doctor (md) used an access kit for the left heart catheterization (lhc) procedure.After the case, the md informed the terumo representative that when inserting the wire into the needle, the tactile feel was rough, describing it as "gritty" and similar to the sensation when the wire is going subintimal.Bleed back confirmed that the wire was not subintimal during vessel access.The patient's condition was stable.No medical or surgical intervention was required.There was no reported blood loss.
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 gss was returned for product evaluation.The returned sample included the needle and guidewire.The sample was subjected to visual analysis.There were signs of dried blood-like substances on the device.The guidewire tip showed signs of use.Functional testing was performed.The guidewire was inserted through the needle, and it went through.There was little resistance when the guidewire tip was inserted, and the transition felt smooth once tip was out of distal end of needle.Measurements were taken.The needle hub and tip id were measured to be 0.022" which is within specification of 0.54 mm.The guidewire od was measured to range from gw od: 0.0200 to 0.0202" which is within specification of 0.54 mm.The complaint cannot be confirmed for guidewire and needle mobility.The exact root cause cannot be determined.The likely root is an obstruction in the needle that lodged after insertion into the patient led to the 'gritty' feeling that the customer experienced.Review of device history record (dhr) showed there were no issues noted during the manufacture of the product that could have contributed to this complaint condition.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: 21045407
• Report Number: 1118880-2024-00205
• Device Sequence Number: 11617243
• Product Code: DYB
• UDI-Device Identifier: 00389701012063
• UDI-Public: (01)00389701012063(17)270201(10)0000684296
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/31/2024

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 Model Number: 80-1060
• Device Catalogue Number: 80-1060
• Device Lot Number: 0000684296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2024
• Supplement Date Received by Manufacturer: 02/07/2025
• Initial Report FDA Received Date: 12/31/2024
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: ULTRASOUND GUIDANCE
• Patient Sex: Unknown