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

Catalog Number	RSS702
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The actual device was returned to the manufacturing facility for evaluation.Visual inspected confirmed a kink at 67mm from the tip of the sheath.Retention samples from the reported and surrounding lots manufactured were evaluated.A visual examination confirmed there were no visual defects.A review of the device history record of the product code/lot number combination was conducted with no relevant findings.A search of the complaint file found similar reports for this part/lot combination from the same facility.See mdr numbers 1118880-2016-00263 and 1118880-2016-00264.There is no evidence that this event was related to a device defect or malfunction.The retention samples were found to be normal product.An exact cause of the reported event cannot be definitively determined based on the available information.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 a kink in the sheath.Follow up communications with the user facility confirmed the following information: the sheath kinked out of the package.There was not patient impact.

• 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: 6122515
• Report Number: 1118880-2016-00257
• Device Sequence Number: 18870423
• Product Code: DYB
• UDI-Device Identifier: 00389701007489
• UDI-Public: 00389701007489
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 11/22/2016

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: 01/31/2019
• Device Catalogue Number: RSS702
• Device Lot Number: UK10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2016
• Initial Report FDA Received Date: 11/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1