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

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2019
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 that they inserted a ik device sheath and dilator.As they removed the dilator from the sheath, they looked down and the entire round rubber valve came out with the dilator.They applied pressure and inserted another sheath.Patient was in stable condition.The procedure outcome was successful.Additional information was received 29october2019: electrophysiology procedure was performed.While the dilator was being removed, the clear rubber valve came out with the dilator.The doctor did not lose wire access.They used another a ik device and successfully finished the case.
Additional Manufacturer Narrative
This report is being submitted as follow up to update and to provide the completed investigation results.One 9fr introducer sheath, dilator, and crosscut valve were received for product evaluation.Visual inspection revealed that the crosscut valve was missing from the sheath hub.The valve was returned but was not inside of the sheath hub.The valve was viewed under microscope and no damage was seen at the center of 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 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 definitely determined based on the available information.Terumo is further investigating the reported event.

• 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: 9353645
• Report Number: 1118880-2019-00324
• Device Sequence Number: 2790015
• Product Code: DYB
• UDI-Device Identifier: 00389701007502
• UDI-Public: 00389701007502
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,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: 09/30/2021
• Device Model Number: N/A
• Device Catalogue Number: RSS902
• Device Lot Number: XE03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Initial Date Received by Manufacturer: 10/25/2019
• Supplement Date Received by Manufacturer: 12/02/2019
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 12/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1