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

Model Number	N/A
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.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 glidesheath slender sheath prolapsed into itself when attempting to remove a 0.018 bard balloon, fully deflated.The patient was in stable condition.The procedure outcome good.Additional information was received on july 8, 2019: the procedure was a angiogram and intervention of superficial femoral artery (sfa).
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update the h3 section and to provide the completed investigation results.One 5fr glidesheath slender was received for product evaluation.No other components were received for product evaluation.Visual inspection revealed that the sheath was folded in reverse and exited through the valve in the opposite direction.Based on the provided information and investigation results there is no evidence that this event was related to a device defect or malfunction.Based on the investigation results, it is likely that the balloon coupled with off-axis movement which created a constriction that led to negative pressure around the inner lumen which could of caused the reported event.However, the exact cause of the reported event cannot be definitely 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 21921
• MDR Report Key: 8784994
• Report Number: 1118880-2019-00175
• Device Sequence Number: 16625746
• Product Code: DYB
• UDI-Device Identifier: 00389701011912
• UDI-Public: 00389701011912
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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
• Report Date (Section B): 07/12/2019

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: 02/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 51-1050
• Device Lot Number: WL20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2019
• Initial Date Received by Manufacturer: 06/27/2019
• Supplement Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 09/04/2019
• 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: 0.018 BARD BALLOON; 0.018 BARD BALLOON