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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2018
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.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 wire (that comes with the sheath) started to unravel when the physician was torqueing it in the radial artery.The wire was removed and there was no injury to patient.The patient was reported to be in good condition.The procedure outcome was good.It is unknown if any other devices or equipment was used with the glidesheath.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date and update.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.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide the completed investigation results.One 0.021" guidewire was returned for evaluation in two pieces.No other accessory components were returned.Visual inspection revealed that the core guidewire had been severed into two pieces.The section containing the distal end measured 0.8945".The coils on this portion had unraveled.The unraveled coils tethered the two separate pieces of the guidewire.Microscopic inspection of the unraveled sections and points of fracture revealed that the fractured point appeared cut.There is no evidence that this event was related to a device defect or malfunction.Based on the event description, the guidewire broke when the physician torqued the guidewire.

• 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: 7777586
• Report Number: 1118880-2018-00084
• Device Sequence Number: 1258793
• Product Code: DYB
• UDI-Device Identifier: 00389701011332
• UDI-Public: 00389701011332
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2018

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: 04/30/2019
• Device Model Number: N/A
• Device Catalogue Number: 50-1060
• Device Lot Number: WC02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 08/14/2018; 08/23/2018
• Initial Report FDA Received Date: 08/13/2018
• Supplement Report FDA Received Date: 08/14/2018; 08/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1