MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT); 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	04/13/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient identifier - requested, not provided.Date of birth - requested, not provided.Ethnicity - requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.The 510(k): k152173.Patient was reported to be (b)(6).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.For 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 the physician accessed the radial artery with the supplied needle, and he introduced the nitinol wire through the needle and into the artery.When the physician removed the needle, it was discovered the nitinol wire had come unwound and the distal tip broke off into the artery.The physician was able to retrieve the tip of the wire from the patient's artery.The patient was reported to be doing fine following the procedure.Additional information was received on april 19, 2018.The event occurred intra-operative.There was no blood loss reported.They used a snare was used to retrieve the broken end from the patient's artery.The procedure was completed successfully.Other equipment or other devices used with the device were: j tip wire, diagnostic cath, and a pig tail.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation.One 0.021" wire was received for product analysis.After decontamination, the guidewire was subjected to visual analysis.The distal tip of the guidewire had uncoiled to the point where the coil is fused with the core of the guide wire.20.5" of wire had uncoiled.Microscopy of the distal tip appears blunt under microscopy as though it was exposed to a sharp edge.Ifu states "do not withdraw the guide wire through the cannula, as shearing of the guide wire may result." there is no evidence that this event was related to a device defect or malfunction.Guidewire shearing may occur if the guidewire is withdrawn through the needle which the ifu warns against.

• Brand Name: GLIDESHEATH SLENDER NITINOL (CONVENIENCE KIT)
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 7488251
• Report Number: 1118880-2018-00036
• Device Sequence Number: 16179996
• Product Code: DYB
• UDI-Device Identifier: 00389701010786
• UDI-Public: 00389701010786
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 05/04/2018

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: 01/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 50-1060
• Device Lot Number: WA10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/13/2018
• Supplement Date Received by Manufacturer: 05/07/2018
• Initial Report FDA Received Date: 05/04/2018
• Supplement Report FDA Received Date: 05/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 47 YR
• Patient Weight: 68