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

Catalog Number	RSS403
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was returned to the manufacturing facility for evaluation.Visual analysis found that there was no presence dried body fluids on the device.Microscopic inspection revealed that the tip was not filleted or flush as is expected in released product.The tip of the dilator was then viewed under microscopy.It was noted that the tip of the dilator had a smooth somewhat flush appearance.There was some evidence of damage to the tip as evidence by the lack of fillet or visible taper typically seen on the dilator.There was no obstruction of the hole.Dimensional testing for the inner diameter of the tip and the length of the dilator met manufacturer specification.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 did not find any other report with the involved product code/lot number combination.There is no evidence that this event was related to a device defect or malfunction.The 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.Device is currently under investigation.
Event or Problem Description
The user facility reported the tip of the 4fr pinnacle separated during use with the involved rss403 device.The following information was provided by the user facility: the tip remained on the wire and was retrieved with no injury to the patient.No other intervention was required and the procedure was completed successfully with a new 4fr pinnacle sheath.The patient condition was reported to be satisfactory.

• 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: 6585514
• Report Number: 1118880-2017-00028
• Device Sequence Number: 10915797
• Product Code: DYB
• UDI-Device Identifier: 00389701007311
• UDI-Public: (01)00389701007311(17)190630(10)VA04
• 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
• Report Date (Section B): 05/23/2017

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: 06/30/2019
• Device Catalogue Number: RSS403
• Device Lot Number: VA04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2017
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2017
• Initial Report FDA Received Date: 05/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 53 YR