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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Reporter occupation- or coordinator.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 the radifocus introducer ii kit sheath was used for femoral access at the beginning of the procedure for a physician modified aortic graft.The sheath leaked blood profusely once the dilator was removed.The dilator was reinserted and the another 9fr sheath was used from a different lot number with no issues.The procedure outcome was not affected.The patient was reported to be in good condition.There was no patient injury, medical/surgical intervention required.There were no other devices or equipment used with the reported product.Additional information was received on 12feb2021.The blood loss was less than 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 9fr introducer sheath and the dilator were received for product evaluation.Visual inspection revealed that the components were returned mated together.The sheath and dilator were separated, and it was noted that the valve was missing from inside the hub, it had dislodged from its intended position.The valve was not returned for evaluation.The dilator was viewed under microscope and the tip was slightly deformed.The sheath tip was also viewed under microscope and no damage was noted.A review of the device history record of the product code/lot# combination was conducted with no findings.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." the complaint can be confirmed for mechanical damage and fluid issue.Based on the investigation results, the likely cause of the event is the dilator was inserted off-center into the hub, dislodging the valve from its intended orientation.It is likely the crosscut valve was dislodged from the hub causing the leakage.The device was in a conforming state when released from terumo control.There is no indication that any manufacturing issues may have led to this event.Currently no action is recommended since this risk evaluation is within the predetermined limits in the fmea.

• 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: 11403589
• Report Number: 1118880-2021-00026
• Device Sequence Number: 11895276
• Product Code: DYB
• UDI-Device Identifier: 00389701007502
• UDI-Public: 00389701007502
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2021

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: 01/01/2023
• Device Model Number: N/A
• Device Catalogue Number: RSS902
• Device Lot Number: 0000001840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Initial Date Received by Manufacturer: 02/10/2021
• Supplement Date Received by Manufacturer: 04/07/2021
• Initial Report FDA Received Date: 03/03/2021
• Supplement Report FDA Received Date: 04/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR