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

Model Number	N/A
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.One 5fr glidesheath slender sheath and dilator were received for product evaluation.The plug lock was partially dislodged from the three-way stopcock body.Visual inspection revealed that the locking pin was missing from the three-way stopcock and therefore could not be evaluated.The plug lock was viewed under microscope and damage was seen at the gate; the gate was bent outward.A review of the device history record of the product code/lot# combination was conducted with no findings.Ifu states: "do not turn the three-way stopcock more than 180 degrees.The cock could misalign or come off and could cause blood leakage or it could shut down the path for the drug." based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.It is likely that the three-way stopcock was turned past 180 degrees causing the locking pin to dislodge, moving the plug lock, and stopping the flow of any fluid through the side tube.However, the exact cause of the reported event cannot be definitively determined based on the available information.
Event or Problem Description
The user facility reported that the doctor involved glidesheath slender was used.The doctor complained of being able to withdraw blood from the three-way stock cock of a sheath that was in the radial artery, however it would not flush forward.He placed a wire in the sheath and exchanged it out for a new sheath without further issue.The bland liver embo procedure was a success.The patient was in stable condition.The event occurred pre-treatment.There were no other devices or equipment used with the reported product.Additional information was received on 31oct2019.It is unknown where the blockage occurred.

• Brand Name: GLIDESHEATH SLENDER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 9363176
• Report Number: 1118880-2019-00328
• Device Sequence Number: 2973009
• Product Code: DYB
• UDI-Device Identifier: 00389701012049
• UDI-Public: 00389701012049
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/22/2019

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: 09/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 80-1050
• Device Lot Number: XF01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2019
• Initial Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1