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

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E3: occupation: coordinator.The actual device has not 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 7fr pinnacle was inserted into the patients right jugular vein on (b)(6) 2023 and was then removed in the cath lab on (b)(6) 2023.When they were removing the dressing off of the patient/pinnacle sheath they noticed the side arm of the sheath was no longer connected to the sheath.There was a pacemaker wire in the sheath, this was blocking flow out of the sheath, preventing any blood loss.The patient was stable.There was no blood loss.The reported event did not result in patient injury and/or require medical or surgical intervention.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section d9, section h3, and to provide the completed investigation results.The actual device has been returned for evaluation.One 7fr ik sheath was returned to terumo medical corporation for assessment.The sample was subject to visual analysis.The side tube is separated 1.4cm from the sheath hub.The complaint can be confirmed for side tube separation.The exact root cause cannot be determined.The likely root cause is the extended use of the sheath combined with patient movement led to the side tube separation.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 hazard based risk table (hbrt).

• 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 ; 4103927218
• MDR Report Key: 18509140
• Report Number: 1118880-2023-00464
• Device Sequence Number: 20784060
• Product Code: DYB
• UDI-Device Identifier: 00389701007267
• UDI-Public: 00389701007267
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2024

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: 11/01/2025
• Device Model Number: N/A
• Device Catalogue Number: RSS701
• Device Lot Number: 0000362492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 02/06/2024
• Initial Report FDA Received Date: 01/12/2024
• Supplement Report FDA Received Date: 03/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2023
• 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: PACEMAKER WIRE.
• Patient Sex: Unknown