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

Catalog Number	RSS502
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device has been returned to the manufacturer facility 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 relevant findings.A search of the complaint file did not find any other report with the involved product code/lot# combination.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 the distal tip of the dilator came off the (b)(4) device.The following information was provided by the user facility: the specific date is unknown at this time; the issue occurred as it was being loaded over the guidewire, prior to insertion into the patient; it was reported that physician and staff noticed the piece, and promptly removed both items from the guidewire and set aside; the procedure was successful; and the patient was unaffected.Additional information was provided on 5/15/17.It was reported that the sample was not used on the patient.The dilator was inserted in the sheath and then the sheath and dilator were put over the wire.It was noted once the sheath/dilator were tracking over the wire that the tip of the dilator had become detached.The device never entered the patient's body and was removed from the wire.
Additional Manufacturer Narrative
(b)(4).A sheath, dilator and a photograph were returned to the manufacturing facility for evaluation.Visual inspection revealed no remnants of dried body fluids present on the device.During decontamination the three way stop cock (3wsc) was opened and the sheath and the side tubing was flushed.Fluid was able to pass through the dilator tip at this time.The tip of the dilator was then viewed under microscopy.It was noted that the tip of the dilator did appear to have sustained some damage.A small portion of material at the tip appeared to have folded in on its self.However, the remaining portion of the tip had a smooth filleted appearance with no jagged anomalies.The tip was missing the tapering that is typically seen at the distal end.The cross cut valve was then dissected from the hub using a razor blade.The valve was then viewed under a microscope.The valve was then bent and a microscopic photograph of the slit on the top of the valve was viewed.Upon being bent the slit appeared normal.The bottom of the valve was also bent and inspected and no defects were observed with the cross cut valve.The length of the dilator was measured and confirmed to meet manufacturer specification.There is no evidence that this event was related to a device defect or malfunction.Although the exact cause of the reported event cannot be definitively determined based on the available information, it is likely the edge of the tip met a hard surface at some point during use which caused the material on one side to roll in on itself.The flushed appearance of the edge of the distal end of the tip indicates that a sharp edge likely contributed to the separation of the tip.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.

• 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: 6572259
• Report Number: 1118880-2017-00034
• Device Sequence Number: 18854995
• Product Code: DYB
• UDI-Device Identifier: 00389701007465
• UDI-Public: (01)00389701007465(17)181231(10)UH20
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 05/17/2017

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: 12/31/2018
• Device Catalogue Number: RSS502
• Device Lot Number: UH20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 04/18/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/17/2017
• Supplement Report FDA Received Date: 05/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1