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

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device has been returned to the manufacturing 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 that there was crack/leak after placement of stopcock.It was reported that the patient condition was good, and the procedure outcome was successful.Additional information was received on 9/25/2017: the crack was where the stop cock would connect and was noticed in the beginning of the procedure when trying to flush the sheath after the stopcock was connected.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.One used 7fr ik sheath was returned for product evaluation and was decontaminated.Visual inspection revealed blood like substance present around the 3wsc and the valve.There was a noted bend mid-way along the body of the sheath.No damage was found that would have allowed fluid to leak.Functional testing conducted.The distal end of the sheath was inserted into a 16 fr balloon.The distal end of the balloon was connected to a controlled air supply system.The 3-way stopcock (3wsc) was then closed and the air pressure was increased.The sheath with the hub, side tubing, and 3wsc were all submerged under tap water for approximately 30 seconds and observed for air bubbles.No air bubbles were observed forming around the hub, sheath, valve or 3wsc.A 7fr dilator for investigational purposes was then inserted into the sheath.This assembly was then again submerged in water.No bubbles were detected.The dilator was then removed and the assembly was submerged for a third and final time.No bubbles were observed.The complaint was unable to be confirmed since no bubble formation was detected around any portion of the assembly.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.

• 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: 6958138
• Report Number: 1118880-2017-00082
• Device Sequence Number: 16474941
• Product Code: DYB
• UDI-Device Identifier: 00389701007342
• UDI-Public: 00389701007342
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/18/2017

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 Model Number: N/A
• Device Catalogue Number: RSS703
• Device Lot Number: VA18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/20/2017
• Supplement Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 10/18/2017
• Supplement Report FDA Received Date: 11/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1