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)
Date of Event	11/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reported device is not an implantable device the actual device has not been returned 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 findings.
Event or Problem Description
The user facility reported that while flushing the sheath on the table prior to the procedure, the tubing appeared to have a leak.The device was not used on the patient.There was no reported blood loss.It was reported that the patient is fine.The reported sheath has no effect on the procedure outcome.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to provide the device return date and the evaluation results.One 9 fr ik device was returned for evaluation and decontaminated.After decontamination, the returned device was subjected to visual analysis.The dilator was not returned with the sheath.Gross analysis of the sheath found no anomalies.No kink was found in the sheath.The hub of the sheath was inspected.The valve was found dislodged along the side of the hub.Flushing the sheath demonstrated leakage from the hub due to the dislodged valve.There was no further analysis that could be performed of the valve.Based on the returned device, the complaint could be confirmed for valve dislodgement.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.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.With no device return 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: 7068340
• Report Number: 1118880-2017-00086
• Device Sequence Number: 16182176
• Product Code: DYB
• UDI-Device Identifier: 00389701007281
• UDI-Public: 00389701007281
• 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,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/29/2017

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: 10/31/2019
• Device Model Number: N/A
• Device Catalogue Number: RSS901
• Device Lot Number: VF03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/07/2017
• Supplement Date Received by Manufacturer: 12/08/2017; 01/31/2018
• Initial Report FDA Received Date: 11/29/2017
• Supplement Report FDA Received Date: 01/05/2018; 02/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1