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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/12/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A3b: gender: n/a.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: ir lab supervisor.The actual device has not 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 doctor was trying to access a heavily calcified posterior tibial artery in a critical limb ischemia (cli) patient.Needle access was achieved in the vessel however, while attempting to advance the wire from the kit through the needle into vessel, the wire got stuck in the calcium burden of the vessel.When trying to pull the wire back, the tip of the wire broke off and was left in the patient.No complications were for the patient because the wire tip was secured in the calcium burden of the occluded vessel.The procedure for patient was leg angiogram for critical limb ischemia (cli).There was no blood loss.There was no patient injury and/or require medical or surgical intervention.No direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.Additional information was received on 14mar2024: there are no plans to remove because the doctor considered it non-significant and that it was not negatively impacting the patient.Approximately 1cm of the wire tip was left in the patient.Patient was stable.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide the completed investigation results.The actual device was not returned; 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.The likely root cause, based on the complaint description, is that the guidewire became stuck in the calcified artery and broke during withdrawal due to high tensional forces.Review of 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).

• 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: 19092971
• Report Number: 1118880-2024-00040
• Device Sequence Number: 15366624
• Product Code: DYB
• UDI-Device Identifier: 00389701011912
• UDI-Public: 00389701011912
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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): 04/11/2024

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: 10/01/2025
• Device Model Number: N/A
• Device Catalogue Number: 50-1050
• Device Lot Number: 0000352305
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2024
• Supplement Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/25/2023
• 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: Other
• Patient Sex: Unknown