MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION DESTINATION; INTRODUCER, CATHETER

Model Number	RSC05
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.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 an angiogram was performed, and the procedure was finished.They removed the sheath to insert the angio-seal.Upon removal of the sheath, it ripped.They were able to remove the entire device.The patient was not harmed, and the procedure was successful.No blood loss was reported.The reported event did not result in patient injury and/or require medical or surgical intervention.Additional information was received on 25jun2025: an angio-seal was used in the case; however, there were no issues with it.The destination was the only problem.The patient was stable.The sheath was visually inspected to confirm that it was removed from the patient entirely.The procedural sheath size was a 6 french.There were no difficulties with arterial access, sheath, guidewire, or catheter insertion.A pre-deployment angiogram was performed.The vessel was not tortuous at the location of the break.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9, update section h3, and to provide the completed investigation results.One 6 french ds sheath was returned for assessment.The sheath was subjected to visual analysis.It was separated from the hub, with the coil stretched out in the separated region until it connects with the other half of the sheath.The complaint can be confirmed for "sheath ripped/separated" based on the status of the returned device.The exact root cause could not be determined.The likely root cause of the sheath separation is that the sheath experienced high tensional forces during withdrawal from the patient's femoral artery, causing it to separate.The device history record (dhr) review determined that the device was in a conforming state when released from terumo control.There is no indication that any manufacturing, design, or quality system issues may have led to this event.Currently, no action is recommended since this risk evaluation is within the predetermined limits in the failure mode and effects analysis (fmea)/hazard based risk table (hbrt).

• Brand Name: DESTINATION
• 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: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 22494244
• Report Number: 1118880-2025-00101
• Device Sequence Number: 4272521
• Product Code: DYB
• UDI-Device Identifier: 00389701007847
• UDI-Public: (01)00389701007847(17)250801(10)0000324158
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K172995
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2025

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: 08/01/2025
• Device Model Number: RSC05
• Device Catalogue Number: RSC05
• Device Lot Number: 0000324158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 07/14/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2023
• 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
• Patient Sex: Unknown