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

Model Number	N/A
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2019
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.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 an unknown issue with the ik device during a procedure.Upon investigation of the return sample on 14oct2019, it was noted that the valve was missing from the sheath hub.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update device evaluated by mfr, and to provide the completed investigation results.One 9fr introducer sheath and the dilator were returned for product evaluation.Visual inspection revealed that the crosscut valve was missing from the sheath hub.The valve was not sent with the dilator and sheath thus no analysis could be performed on the crosscut valve.The dilator did not have any damage, gross anomalies, or occlusions.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.Based on the investigation results it is likely that the dilator was inserted off-center into the valve, dislodging the valve from its intended orientation.However, 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: 9356957
• Report Number: 1118880-2019-00345
• Device Sequence Number: 18952423
• Product Code: DYB
• UDI-Device Identifier: 00389701007502
• UDI-Public: 00389701007502
• 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,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2019

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: 11/30/2021
• Device Model Number: N/A
• Device Catalogue Number: RSS902
• Device Lot Number: XG12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Initial Date Received by Manufacturer: 10/26/2019
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1