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	06/23/2020
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 product code/lot# combination was conducted with no findings.This report is for the first device reported, for the second device reported that was used on the same patient see mdr 1118880-2020-00171, and for the third device reported that was used on the same patient see mdr 118880-2020-00172.
Event or Problem Description
The user facility reported that the ik device valve appeared to be leaking, in addition there were air bubbles noticed inside the port when a syringe was used to pull blood back for a act purposes.This 9 french sheath was used for a electrophysiology (ep) procedures, in addition three additional sheaths of various sizes such as a 8fr were used.The patient was in stable condition and the procedure was satisfactory.The blood loss was less than 250cc's.An i.C.E.Ep catheter was placed in the 9 french sheath.There was no patient injury, medical/surgical intervention required.
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 9fr introducer sheath was received for product evaluation.Visual inspection revealed no damage or anomalies noted on the sheath.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 (equivalent to 222 mmhg).The setup was submerged underwater for approximately 30 seconds.No air bubbles were observed.A dilator for investigational purposes was then inserted into the sheath per the device ifu.This assembly was submerged in water, and bubbles were observed.The device failed leak testing.To check for damage at the crosscut valve, the valve was dissected and observed under microscope.Damage was seen at the center of the crosscut valve.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 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
• MDR Report Key: 10319598
• Report Number: 1118880-2020-00170
• Device Sequence Number: 2679284
• Product Code: DYB
• UDI-Device Identifier: 00389701007502
• UDI-Public: 00389701007502
• Combination Product (Y/N): N
• 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): 07/24/2020

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: 07/31/2022
• Device Model Number: N/A
• Device Catalogue Number: RSS902
• Device Lot Number: YC12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2020
• Initial Date Received by Manufacturer: 06/29/2020
• Supplement Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 07/24/2020
• Supplement Report FDA Received Date: 08/20/2020
• 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: 6 FR SHEATH & 5 FR. SHEATH; I.C.E. EP CATHETER, 8 FR. SHEATH
• Patient Age: 74 YR