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

Model Number	N/A
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	07/06/2020
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
The user facility reported that after gaining brachial vein access and inserting a catheter and wire into the ik device sheath the wire and catheter became stuck inside the sheath.The wire, catheter, and sheath were removed.Pressure was held.Access was obtained again, and a second sheath inserted.Blood loss was less than 250cc's.The patient was in stable condition.The procedure outcome was aborted, not due to access.Additional information was received on 09july2020: it was a benson wire and a bern catheter.The wire was an.035.The wire was in, and the catheter was advanced over the wire.There was no difficulty at the crosscut valve.The assumption was either the catheter got stuck in the sheath(middle) or distal portion.Catheter, and sheath were removed, and pressure was held, then access was gained again at same access point, ultrasound was utilized.No obstructions no visualized clots or obstruction in the vein prior to access.Kinks were not noted in the sheath.Anatomy was not mentioned as an issue.Procedure was being performed was wavelinq fistula creation.The sheath was used to deliver the product to create a fistula.The procedure requires access in vein and artery.Additional information was received on 09july2020: the wavelinq catheter was not the catheter that got stuck.It was during a wavelinq procedure.It was, i believe a berm catheter, with an 035 wire.The tourniquet was on the opposite side of where we were advancing the products, in theory the vein should have been bigger.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section d9, update section h3, and 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: 10344639
• Report Number: 1118880-2020-00185
• Device Sequence Number: 19577793
• Product Code: DYB
• UDI-Device Identifier: 00389701011950
• UDI-Public: 00389701011950
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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: 06/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 60-1050
• Device Lot Number: YA08
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/06/2020
• Supplement Date Received by Manufacturer: 08/28/2020
• Initial Report FDA Received Date: 07/30/2020
• Supplement Report FDA Received Date: 09/17/2020
• 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: BENSON WIRE, BERN CATHETER; BENSON WIRE, BERN CATHETER
• Outcome Attributed to Adverse Event: Required Intervention