MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA TERUMO NAVICROSS SUPPORT CATHETER; CATHETER, PERCUTANEOUS

Model Number	WS*NS35153H
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	07/26/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has 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 records and the product release decision control sheet of the involved product/lot# combination was conducted with no findings.(b)(4).
Event or Problem Description
The user facility reported that the involved navicross was damaged during use.There were no issues with the condition of the patient.The outcome was good, a new navicross was used.Blood loss was reported to be less than 250cc's.Additional information was received on 05aug2019.The procedure was a peripheral case, and the device kinked during use.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide a correction.The reported event has been deemed not reportable based off the investigation of the actual sample return.The actual sample had no fracture on the shaft, and the total length was measured to be approximately 1500mm, which is the value equivalent to that of the current product code/lot# combination.It was confirmed that there was no fragment missing from the actual device.

• Brand Name: TERUMO NAVICROSS SUPPORT CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 8893361
• Report Number: 9681834-2019-00149
• Device Sequence Number: 286582
• Product Code: DQY
• UDI-Device Identifier: 04987350709301
• UDI-Public: 04987350709301
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K110540
• 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
• Report Date (Section B): 08/14/2019

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: 02/28/2022
• Device Model Number: WS*NS35153H
• Device Catalogue Number: NC35150
• Device Lot Number: 190322
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 09/10/2019
• 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: GLIDEWIRE.
• Patient Age: 83 YR