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

Catalog Number	RSS603
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device was returned to the manufacturing facility for evaluation.Visual inspection revealed remnants of dried body fluids on the cap of the sheath's hub, which is consistent with used devices.Visual inspection revealed no defects.Functional testing was conducted and could not reproduce the reported complaint.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.There is no evidence that this event was related to a device defect or malfunction.The investigation results verified that the actual device was normal product with no anomalies which would lead to the reported leak.The exact cause of the reported issue cannot be definitively determined.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 blood leaking during a procedure.Follow up communication with the user facility confirmed the following information: during a neurointerventional case the staff noticed blood leaking from around the hub distal to the cross cut valve; the leaking did not occur through the valve itself but around the hub and before the tube portion of the sheath; blood loss was estimated at less than 10cc; there was no difficulty inserting the sheath into the patient; the procedure outcome was good; and the patient's condition was reported to be good.Additional information was received on 5/09/2017.The patient's condition was reported to be excellent.

• 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: 6585248
• Report Number: 1118880-2017-00035
• Device Sequence Number: 18854916
• Product Code: DYB
• UDI-Device Identifier: 00389701007335
• UDI-Public: (01)00389701007335(17)190731(10)VC01
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: 07/31/2019
• Device Catalogue Number: RSS603
• Device Lot Number: VC01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2017
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN CATHETERS