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

Model Number	RSC06
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explante.The actual device was not available; therefore, the actual device will not be 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 distal end of the sheath was found broken.The sheath was disposed of due to blood contamination.No blood loss occurred.Additional information received on 12 feb 2025: the procedure being performed was a right renal artery stenting.The broken sheath was discovered during the procedure and was replaced with a new device to complete the procedure.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide the completed investigation results.The actual device was not returned, so an evaluation could not be conducted.The complaint can be confirmed for 'sheath tip deformed' based on the picture provided.The exact root cause cannot be determined.The likely root cause is the sheath tip deformed due to resistance at the access site.The device history record was reviewed to ensure each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with terumo medical corporation specifications and procedures and the device was released in a conforming state.Currently, no action is recommended since the risk evaluation is within the predetermined limits in 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: 21516758
• Report Number: 1118880-2025-00031
• Device Sequence Number: 8334746
• Product Code: DYB
• UDI-Device Identifier: 00389701007854
• UDI-Public: (01)00389701007854(17)280501(10)0000462223
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2025

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: 05/01/2026
• Device Model Number: RSC06
• Device Catalogue Number: RSC06
• Device Lot Number: 0000462223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2025
• Supplement Date Received by Manufacturer: 03/27/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/01/2026
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian