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	11/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter occupation- cardio tech/inventory coordinator.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
The user facility reported that the involved glidesheath slender was used, and the wire in the nitinol radial kit was inserted into the radial artery.It was suspected the wire entered a side branch of the radial artery and the wire uncoiled and broke as it was attempted to be pulled back into the needle.The distal portion of the wire was left in the patient.They gained femoral access to continue with the cardiac catheterization.Vascular surgery was to be consulted after the case for removal of the distal portion of the wire.The patient was reported to be in stable condition.The procedure was completed.Additional information was received on 02dec2020.Vascular was consulted and it was decided to leave the wire.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.One 6fr glidesheath slender guidewire was received for product evaluation, no other components were returned for evaluation.Visual inspection of the guidewire revealed that the outer coil was unraveled at 41 cm from the stiff end.There were no other anomalies noted on the guidewire.Ifu states: "do not withdraw the guide wire through the needle, as shearing of the guide wire may result.If resistance is met, do not advance or withdraw the mini guide wire until the cause of the resistance is determined." the complaint can be confirmed for guidewire mechanical separation due to the damage noted on the sample.It is likely that pulling the guidewire back through the needle sheared the outer coiling resulting in the guidewire unraveling.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 fmea.

• Brand Name: GLIDESHEATH SLENDER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 11018506
• Report Number: 1118880-2020-00327
• Device Sequence Number: 4396531
• Product Code: DYB
• UDI-Device Identifier: 00389701011332
• UDI-Public: 00389701011332
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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: 11/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 50-1060
• Device Lot Number: YG10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2020
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 12/16/2020
• Supplement Report FDA Received Date: 01/22/2021
• 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
• Patient Age: 70 YR