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

Model Number	N/A
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2018
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.For this reason, evaluation code has been referenced in the conclusions.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 upon removal of a bard lutonix balloon, the sheath inverted and folded on itself back up through the hub when using the glide sheath slender device.The patient was stable.The procedure outcome was a success.Additional information was received on 7/5/2018: the procedure being performed was a peripheral vascular intervention (pvi).
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information.In the initial report, it was stated that the sample was available however; additional information was provided that the sample was discarded.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide the completed investigation results.The evaluation of the actual device could not be conducted due to the device not being returned.With no device return, the exact cause of the reported event cannot be definitively determined based on the available information.

• 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: 7703453
• Report Number: 1118880-2018-00033
• Device Sequence Number: 2644232
• Product Code: DYB
• UDI-Device Identifier: 00389701011363
• UDI-Public: 00389701011363
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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

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: 04/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 50-1060
• Device Lot Number: WD07
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 08/06/2018; 08/06/2018
• Initial Report FDA Received Date: 07/19/2018
• Supplement Report FDA Received Date: 08/22/2018; 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1