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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier, age & date of birth, sex, weight, ethnicity, and race: unknown.Implanted date: device was not implanted.Explanted date: device was not explanted.Device available for evaluation: the device cannot be obtained due to undisclosed facility.Reporter name, address, and phone number: unknown due to undisclosed facility.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.A review of the device history record of the product code/lot# combination was conducted with no findings.
Event or Problem Description
A maude database search conducted on 20apr2021 found a maude report number mw5099825.The event description states: "patient presented for right radial artery access under ultrasound guidance in cath lab during hospitalization.After the procedure, it was discovered that patient had retained a piece of the terumo french # 4 sheath.Upon assessment and attempts to retrieve, it was determined that the sheath would remain, as there was no harm to patient's vessel and good flow to the arm.No further issues noted, and patient discharged in good condition.Fda safety report id # (b)(4).".
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 as notification that this report is a duplicate report to a report that was already submitted, therefore this report is not needed.Please see mdr 1118880-2021-00044 for the report that was previously reported for this event.

• Brand Name: GLIDESHEATH SLENDER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 11846485
• Report Number: 1118880-2021-00101
• Device Sequence Number: 19811086
• Product Code: DYB
• UDI-Device Identifier: 00389701012049
• UDI-Public: 00389701012049
• Combination Product (Y/N): N
• 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: company representative,health
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2021

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: 03/01/2023
• Device Model Number: N/A
• Device Catalogue Number: 80-1050
• Device Lot Number: 0000011031
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 06/17/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other