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

Model Number	N/A
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Initial reporter occupation: vascular surgeon.A review of the device history record of the product code/lot number combination was conducted with no findings.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.
Event or Problem Description
The user facility reported that while trying to aspirate from the sheaths sideport, the doctor was unable to draw any blood.She suspected there may be a crack in the sheaths side port and decided to exchange for another 5fr pinnacle sheath.The case was an abdominal angiogram with runoff (aaro)/diagnostic of the right leg.The sheath was successfully placed in the left groin with no issues.Pictures were taken with the original sheath.The attempt to aspirate was done mid case when the issue was noticed.The procedure continued successfully after the sheath exchange.The patient was stable.The estimated blood loss was less than 250cc.Additional information was received on 06 feb 2023: she was pulling back air, not blood, and suspected a crack or hole.When they were aspirating, they used a syringe and pulling from the 3-way stopcock.
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 ik sheath was returned for product evaluation.The sample was subject to visual analysis.No damage is noted on the sheath or 3wsc.The sample was subject to leak testing.For leak testing, the ik sheath distal end was connected to leak testing equipment providing constant air pressure at 4.3 psi to simulate low pressure leak testing.The device was pressurized and placed under a water bath to visualize bubble formation to test for the presence of a leak.The 3wsc was opened for both the side port and main port.After several minutes under pressure test, there were no leaks present from the 3wsc.The same leak testing was performed again and a 5fr dilator was inserted through the valve to check for air bubbles.After several minutes of insertion and removal of the dilator, air bubbles were observed from the valve during insertion of the dilator.The complaint cannot be confirmed for damage of the 3wsc because the returned sample passed leak testing and no damage was noted.The exact root cause cannot be determined.It is possible there was a blockage in the sheath that prevented the user from aspirating blood during the procedure.The valve leak is likely due to off center insertion of the dilator.Review of device history record (dhr) showed there were no issues noted during manufacture of the product that could have contributed to this complaint condition.Currently no action is recommended since this risk evaluation is within the predetermined limits in the design failure mode & effects analysis (dfmea).

• Brand Name: RADIFOCUS INTRODUCER II KIT
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer Contact: gina digioia ; 950 elkton blvd.; elkton, MD 21921 ; 6402040886
• MDR Report Key: 16462185
• Report Number: 1118880-2023-00015
• Device Sequence Number: 11341871
• Product Code: DYB
• UDI-Device Identifier: 00389701007465
• UDI-Public: 00389701007465
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K954234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2023

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: 01/01/2025
• Device Model Number: N/A
• Device Catalogue Number: RSS502
• Device Lot Number: 0000217626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Supplement Date Received by Manufacturer: 03/16/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 04/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GLIDEWIRE ADVANTAGE; OMNI CATHETER
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 122 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American