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

Catalog Number	WS*NA350N3H
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/13/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D4 - udi number is not required for this product code/lot number combination.The di portion is provided.The actual device has not been received by the manufacturing facility for evaluation.The investigation is currently ongoing.A follow up report will be submitted when the investigation is complete, but no later than 30 days from the date that this report was sent.For this reason code 11 was used in the conclusions section of h6.A review of the device history record and the product release decision control sheet of the product code/lot# combination was conducted with no relevant findings.A search of the complaint file did not find any other report with the involved product code/lot# combination.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.Exemption number e2015022.All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.- attachment: [mw5067375.Pdf].
Event or Problem Description
The terumo medical facility received a medwatch report number mw5067375 on february 3, 2017.The user facility reported that the tip of the navicross device broke off during a procedure.Follow up communication with the user facility confirmed the following information: during a common femoral intervention the tip of the navicross broke off inside of the vessel; it was reported that the vessel was very calcified and the navicross became stuck; upon removal of the device it was noticed that the tip broke off; the catheter was removed but the tip remained in the patient; the procedure was completed; and the patient was transferred to another hospital for surgical removal of the navicross tip.
Additional Manufacturer Narrative
This report is being submitted as follow up number 1 to provide an update on the status of the report.The actual device has not been received by the manufacturing facility for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this (b)(4) was used in the conclusions of evaluation codes.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
Additional Manufacturer Narrative
The actual device was determined to be unavailable and was not returned to the manufacturing facility for evaluation.With no return of the actual sample for evaluation, the investigation of this complaint was limited and a definitive cause of the reported event was unable to be determined.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.Device not available.

• Brand Name: TERUMO NAVICROSS SUPPORT CATHETER
• Common Device Name: CATHETER
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, shizuoka 418 ; JA 418
• MDR Report Key: 6329941
• Report Number: 9681834-2017-00019
• Device Sequence Number: 19001782
• Product Code: DQY
• UDI-Device Identifier: 04987350709202
• UDI-Public: 04987350709202
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/14/2017

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: 05/31/2019
• Device Catalogue Number: WS*NA350N3H
• Device Lot Number: 160615
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/17/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/14/2017
• Supplement Report FDA Received Date: 03/15/2017; 04/27/2017
• 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: 63 YR