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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Blood Loss (2597); Device Embedded In Tissue or Plaque (3165)
Date of Event	04/03/2019
Type of Reportable Event	Serious Injury
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 a glidesheath nitinol wire was advanced through the needle, and then the doctor removed the wire.The wire was badly frayed.The doctor gained access during a radial procedure.The estimated blood loss was less than 250cc.Additional information was received on april 18, 2019.The patient was in stable condition.They switched to femoral access and completed the left heart catheterization (lhc).No intervention was necessary.Part of the wire was left in the patient and was reported to still be there.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update , and to provide the completed investigation.One 6fr glidesheath slender guidewire was received for product evaluation.Visual inspection revealed that the guidewire was returned in an unraveled state, which was visually examined under the microscope.The distal tip of the guidewire had uncoiled to the point where the coil was fused with the core of the guide wire.The stiff end measured to be 0.0210" using the vernier caliper which is within the manufacturer specifications.Ifu states:"do not withdraw the guide wire through the needle, as shearing of the guide wire may result." 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was related to a device defect or malfunction.It is likely that the event may have occurred due to the guidewire being withdrawn through the needle.However, the exact cause of the reported event cannot be definitively determined based on the available information.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: 8531963
• Report Number: 1118880-2019-00085
• Device Sequence Number: 13885979
• Product Code: DYB
• UDI-Device Identifier: 00389701011332
• UDI-Public: 00389701011332
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2019

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: 06/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 50-1060
• Device Lot Number: XA02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Initial Date Received by Manufacturer: 04/05/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 04/19/2019
• Supplement Report FDA Received Date: 05/15/2019
• 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: Other
• Patient Age: 57 YR
• Patient Weight: 90