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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E3: occupation: inventory specialist.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 involved ik device proximal portion of the sheath crumbled upon insertion.Attempted to insert the wire through the sheath and was unable to.The sheath was cut to try and get wire access.This was not successful, and access to the vessel was lost.The patient was not injured during the event and medical/surgical intervention was not needed.Additional information was received on 26 jan 2024: patient procedure was a neuro diagnostic procedure.To resolve the issue, the sheath was pulled, and vessel access was lost.Pressure was held at the site.No difficult anatomy noted.The patient was in stable condition.No concomitant medical products were used with the involved device.
Additional Manufacturer Narrative
The actual device is no longer available for returned; therefore, an evaluation of the actual device was unable to be conducted.However, a reference photo of the actual sheath was provided, and the sheath was cut under the sheath hub.The complaint can be confirmed for sheath damage.Without a sample, the exact root cause cannot be determined.The likely root cause is the sheath was kinked near the hub and prevented insertion over the guidewire.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 ; 6402040886
• MDR Report Key: 18755200
• Report Number: 1118880-2024-00008
• Device Sequence Number: 3703289
• Product Code: DYB
• UDI-Device Identifier: 00389701007465
• UDI-Public: 00389701007465
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2024

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: 04/01/2026
• Device Model Number: N/A
• Device Catalogue Number: RSS502
• Device Lot Number: 0000439577
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2024
• Supplement Date Received by Manufacturer: 03/16/2024
• Initial Report FDA Received Date: 02/21/2024
• Supplement Report FDA Received Date: 04/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown