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

Model Number	50-1050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	07/23/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device is not available for return; therefore, an evaluation of the actual device was unable to be conducted.The complaint cannot be confirmed for guidewire separation because the sample was not returned for assessment.Without a sample and context around the breakage of the guidewire, the cause cannot be determined.Historically, guidewire separations have occurred due to pulling the guidewire back through the needle or due to high tensional forces during withdrawal.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).
Event or Problem Description
Terumo medical received an fda medwatch report # mw5158312.The event description states: "cerebral angio and smatxi via right radial approach done.Piece of wire was retained during the procedure.Attempts made to fish out some of the wire piece by making the nick larger and some was retrieved but not all.Fluoro image shows the wire remnant appears to be extra-arterial compared to indwelling sheath.Vascular surgery consulted for retained wire at right radial access site.Duplex scan: the right radial artery appears to be occluded.There appears to be a shadow noted in the distal forearm that is possibly intra-arterial in the radial artery of the right upper extremity.On (b)(6) 2024: to operating room for right radial cutdown, removal of retained wire.".

• 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 ; 4103927218
• MDR Report Key: 20360721
• Report Number: 1118880-2024-00144
• Device Sequence Number: 8127271
• Product Code: DYB
• UDI-Device Identifier: 00389701011363
• UDI-Public: (01)00389701011363(17)260901(10)0000554944
• Combination Product (Y/N): N
• PMA/510(K) Number: K173831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/03/2024

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 Expiration Date: 09/01/2026
• Device Model Number: 50-1050
• Device Catalogue Number: 50-1050
• Device Lot Number: 0000554944
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 10/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Ethnicity: Hispanic
• Patient Race: White