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	Blood Loss (2597)
Date of Event	05/30/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was not 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.This report is for the second device reported, for the first device reported that was used on the same patient see mdr 1118880-2019-00141.
Event or Problem Description
The user facility reported that the valve on the ik device leaked during the case, switched for engage.The procedure was completed successfully.The patient was reported to be in stable condition.Additional information was received on june 11, 2019.Two devices failed followed by the use of a competitors device.The procedure being performed was a transcatheter aortic valve replacement (tavr).Blood loss was less then 250cc.
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 sheath along with the dilator was returned for evaluation.Visual inspection revealed that no anomalies were noted with the sheath nor the dilator.Functional testing was performed.The sheath was then subjected to leak testing.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.The setup was submerged underwater for approximately 30 seconds.No air bubbles were observed forming around the sheath hub.A dilator for investigational purposes was then inserted into the sheath.This assembly was submerged in water, and no bubbles were detected for 30 seconds.Post leak testing, the crosscut valve was dissected from the sheath to observe for any damage which may have caused the leakage.The microscopic examination did not reveal any damage to the valve.No anomalies were found with the sheath inner lumen.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.The investigation results verified the returned sample was of the normal product.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: 8736585
• Report Number: 1118880-2019-00142
• Device Sequence Number: 2636936
• Product Code: DYB
• UDI-Device Identifier: 00389701007489
• UDI-Public: 00389701007489
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: N/A
• Device Catalogue Number: RSS702
• Device Lot Number: XC06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 07/26/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 07/30/2019
• 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: AMPLATZ WIRE; AMPLATZ WIRE
• Outcome Attributed to Adverse Event: Required Intervention