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 Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Lot number - potential lot was provided.Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was not returned, therefore an evaluation of the actual device was unable to be conducted.A review of the device history record of the product code/ potential lot# combination was conducted with no findings.With no device return, the exact cause of the reported event cannot be definitively determined based on the available information.
Event or Problem Description
The user facility reported that when the ik device valve is turned off to the patient and it has been flushed, blood is still getting into the sheath.The physician is concerned clot builds up in the sheath and then when he advances the catheter, he is pushing clot up the aorta with the catheter.Additional information was received 08january2019: the case performed was a heart catheterization or a peripheral leg case.The procedure outcome was successful, this issue did not lead to blood loss.The patient was stable and the case was completed with the same sheath.

• 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: 9641617
• Report Number: 1118880-2020-00012
• Device Sequence Number: 11381422
• Product Code: DYB
• UDI-Device Identifier: 00389701007472
• UDI-Public: 00389701007472
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2020

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: 03/31/2022
• Device Model Number: N/A
• Device Catalogue Number: RSS602
• Device Lot Number: XM23
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2020
• Initial Report FDA Received Date: 01/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1