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

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	12/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, (b)(4) has been referenced in the conclusions section of evaluation codes.A review of the device history record of the product code/lot# combination was conducted with no findings.
Event or Problem Description
The user facility reported that during a thoracic endograft procedure, the physician said that the valve was leaking abnormally from the valve.The reported blood loss was less than 250 cc.It was reported that the patient is fine.It was reported that the procedure outcome was completed.
Additional Manufacturer Narrative
This report is being submitted to provide the completed investigation results.The evaluation of the actual device could not be conducted due to the device not being returned.

• 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: 7194867
• Report Number: 1118880-2017-00100
• Device Sequence Number: 19151051
• Product Code: DYB
• UDI-Device Identifier: 00389701007663
• UDI-Public: 00389701007663
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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): 01/16/2018

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: 10/31/2019
• Device Model Number: N/A
• Device Catalogue Number: RSS804
• Device Lot Number: VF03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/20/2017
• Supplement Date Received by Manufacturer: 01/27/2018
• Initial Report FDA Received Date: 01/16/2018
• Supplement Report FDA Received Date: 01/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 83 YR
• Patient Weight: 112