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

Model Number	N/A
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 an issue with the glidesheath slender, they had trouble getting the sheath wire to advance through the sheath itself.It appeared to have a "bulb shape" at the soft tip.They tried the distal end of the wire and it advanced with no issue.The patient was in stable condition.They were able to use the reported device and no other equipment or devices were used with the reported product.The procedure outcome was a success.Additional information was received 19august2019: the procedure was a diagnostic left heart cath.
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 guidewire from the glidesheath slender kit was returned for evaluation.Visual inspection revealed that there were no outward anomalies noted on the wire turns.The wire was examined for swells and gaps in the surface and none were found.There were no breaks in the coil.The end caps of wire were then examined under a microscope and on the floppy end, the end weld was found to be offset.The amount of offset made the welded cap stand out of the outer diameter edge.The guidewire was measured be 0.061mm which was within the specification.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 offset end weld led to difficulty in mating with the needle.The exact cause of the reported event cannot be definitively determined based on the available information.Terumo is further investigating the reported event.

• Brand Name: GLIDESHEATH SLENDER
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 8960003
• Report Number: 1118880-2019-00235
• Device Sequence Number: 19619747
• Product Code: DYB
• UDI-Device Identifier: 00389701012070
• UDI-Public: 00389701012070
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2019

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: 10/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 80-1050
• Device Lot Number: XF08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2019
• Initial Date Received by Manufacturer: 08/11/2019
• Supplement Date Received by Manufacturer: 10/15/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 97