MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION RADIFOCUS INTRODUCER II KIT; INTRODUCER, CATHETER

Catalog Number	RSS901
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device has not been returned to 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.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
Event or Problem Description
The user facility reported valve leakage on the involved device.Follow up communication with the user facility confirmed the following information: the md attempted to flush the sheath and noticed saline coming out the valve and the device was not used on the patient.
Additional Manufacturer Narrative
This report is being submitted as follow up number 1 to provide the retention sample investigation results.The actual device has not been returned to the manufacturing facility.Therefore, the investigation was based upon evaluation of the user facility information and retention samples from the reported and surrounding lots.A visual examination of the samples confirmed there were no visual defects.In addition, functional testing confirmed the products met manufacturing specification.A review of the device history record 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.The investigation results verified that the retention samples were normal product with no anomalies which would lead to the reported leak.The exact cause of the reported event cannot be definitively determined and there is no evidence that this event was related to a device defect or malfunction.All available information has been forwarded to the manufacturing facility for appropriate tracking, trending and follow up.
Additional Manufacturer Narrative
This report is being submitted as follow up number 2.On january 31, 2017 it was confirmed that the actual sample is not available to be returned to the manufacturing facility for evaluation.For the retention sample evaluation please see the previous report.All available information has been forwarded to the manufacturing facility for appropriate tracking, trending and follow up.Actual device not available.

• Brand Name: RADIFOCUS INTRODUCER II KIT
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 6176636
• Report Number: 1118880-2016-00272
• Device Sequence Number: 10875751
• Product Code: DYB
• UDI-Device Identifier: 00389701007281
• UDI-Public: 00389701007281
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K954234
• 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): 12/15/2016

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: 10/31/2018
• Device Catalogue Number: RSS901
• Device Lot Number: UF25
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/17/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 01/12/2017; 02/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1