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	01/07/2020
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 potential product code/lot# combination was conducted with no findings.
Event or Problem Description
The user facility reported that when the ik valve was turned off to the patient, and had been flushed, blood was still getting into the sheath.The physician was concerned that clots build up in the sheath and then when he advances the catheter, he is pushing the clot up the aorta with the catheter.Additional information was received on 08jan2020.The case was reported to be either a heart catheterization or a peripheral leg case.The case was successful and was completed with the same sheath.The event did not lead to blood loss, the patient was in stable condition.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.One 6fr ik introducer sheath was returned for product evaluation.Visual inspection revealed there was no damage seen on the device.Leak testing was performed.The distal end of the sheath was inserted into a 12 fr balloon.The distal end of the balloon was connected to a controlled air supply system.The 3-way stopcock (3wsc) was closed, and the air pressure was increased to 4.3 psi (equivalent to 222 mmhg).The setup was submerged underwater for approximately 30 seconds and air bubbles were observed.A dilator for investigational purposes was then inserted into the sheath.This assembly was submerged in water, and air bubbles were detected for 30 seconds.To check for damage at the crosscut valve, the valve was dissected and observed under microscope.Damage was observed at the center of the crosscut valve.The ifu states: "insert the dilator into the valve center of the sheath.Forced insertion of the dilator which misses the center of the sheath valve may cause damage, and result in blood leakage." 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 off-center insertion of the dilator into the valve may have caused the reported event.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: 9649239
• Report Number: 1118880-2020-00022
• Device Sequence Number: 14174057
• 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,Followup
• Report Date (Section B): 01/30/2020

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: 03/31/2020
• Device Model Number: N/A
• Device Catalogue Number: RSS602
• Device Lot Number: XM23
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Received by Manufacturer: 01/07/2020
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 01/30/2020
• Supplement Report FDA Received Date: 02/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: JR CATHETERS