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	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.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.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 27april2020 found a maude report number # (b)(4).The event description states: "the md passed the nitinol guide wire over the needle into the patient's radial artery.When the md pulled the guide wire out, the proximal head of the wire detached, leaving behind some wire and an inner string inside the patient's wrist.The fragment was retrieved and removed.No harm to patient." terumo medical received an fda medwatch (b)(4) with additional information on 28april2020.The event description states: "the md passed the nitinol guide wire over the needle into the patient's radial artery.When the md pulled the guide wire out, the proximal head of the wire detached, leaving behind some wire and an inner string inside the patient's wrist.The fragment was retrieved and removed.No harm to patient.".
Additional Manufacturer Narrative
This report is being submitted 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.With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: GLIDESHEATH SLENDER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton, md
• MDR Report Key: 10078442
• Report Number: 1118880-2020-00101
• Device Sequence Number: 14416080
• Product Code: DYB
• UDI-Device Identifier: 00389701011363
• UDI-Public: 00389701011363
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K173831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2020

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 Expiration Date: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 50-1050
• Device Lot Number: XH17
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/27/2020
• Supplement Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 05/21/2020
• Supplement Report FDA Received Date: 05/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR