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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2018
Type of Reportable Event	Malfunction
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
The user facility reported the user inserted the sheath into the rt radial artery and removed the dilator.The sheath then kinked immediately where the hub and sheath are attached and caused the sheath to flip up.Unremarkable anatomy with normal size radial artery.The md had to hold down hub of the sheath to be able to draw blood from the sidearm.A suture eye was utilized to secure sheath to skin and the case was completed without incident.The patient is stable and in good condition.The procedure was completed successfully.Additional information was received on 8/7/2018.There was no blood loss reported due to the event.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to update, and provide the completed investigation results.One 6fr glidesheath slender was returned for evaluation.No other components were received with the sheath.Visual inspection revealed that there were two kinks in the sheath approximately 3.83" and 3.3745" from the distal tip of the sheath.The kink was just below the hub of the sheath.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information.It was initially reported that a suture eye was used to secure to the skin, however, there is no suture eye on the glidesheath and provide the device return date.
Event or Problem Description
Additional information was received on 8/16/18.A tegaderm clear dressing was used to secure the sheath during this procedure.

• Brand Name: GLIDESHEATH SLENDER NITINOL
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 7776279
• Report Number: 1118880-2018-00096
• Device Sequence Number: 19152485
• Product Code: DYB
• UDI-Device Identifier: 00389701011981
• UDI-Public: 00389701011981
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K142183
• 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,Followup
• Report Date (Section B): 08/13/2018

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: 09/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 60-1065
• Device Lot Number: WF02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Initial Date Received by Manufacturer: 08/06/2018
• Supplement Date Received by Manufacturer: 08/16/2018; 08/23/2018
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 08/20/2018; 08/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SUTURE EYE