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

Model Number	15-1060
Medical Device Problem Codes	Fracture (1260); Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E3: occupation: interventional cardiologist.The actual device has been returned for evaluation.One 6 fr glidesheath slender device was returned.The returned sample includes the guidewire and shelf pack.The device was subjected to visual analysis.The outer coiling of the guidewire is unraveled from the inner core.The complaint can be confirmed for guidewire mechanical damage.The exact root cause cannot be determined.The likely cause is the guidewire was sheared with removed from the needle causing the unravelling of the guidewire.The device history record review determined 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 hazard based risk table (hbrt).
Event or Problem Description
The user facility reported that the needle was inserted, but the wire would not track, although it was suspected that the needle was inside the vessel.Therefore, the wire was pulled out.At this point, it was noticed that the wire was unraveling.The wire was saved, although it appears the needle was thrown away.The procedure for the patient was a left heart catheterization.The patient's condition is stable, with no blood loss.The event occurred intra-operatively.No concomitant medical products were used with the involved device.Pending results of a computed tomography (ct) scan to determine if subsequent action is needed or if all components were removed.Additional information was received on 17 april 2025: the ct scan shows the filament is in the body.It is listed as non-occlusive and appears to not be in the artery.The patient wants it removed, so scheduling for removal is underway.

• Brand Name: GLIDESHEATH
• 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: 22023001
• Report Number: 1118880-2025-00058
• Device Sequence Number: 15648089
• Product Code: DYB
• UDI-Device Identifier: 00389701009933
• UDI-Public: (01)00389701009933(17)270701(10)0000842271
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 15-1060
• Device Catalogue Number: 15-1060
• Device Lot Number: 0000842271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female