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

Model Number	RSR04
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
A territory manager from another company sent an image of a destination sheath.They indicated that the case was a jet-stream case with boston scientific to our terumo field clinical specialist.The procedure was a peripheral angiogram and arthrectomy.The patient was stable and the estimated blood loss was less than 250cc.Additional information was received on 15may2025: the sheath broke on the shaft and the braiding was exposed while in the patient.The vascular surgeon was certain she removed all of the sheath.A second 7fr destination sheath was opened and used without any difficulty.
Additional Manufacturer Narrative
E3: occupation: vascular surgeon.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.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide the additional information in section b5 and to provide the completed investigation results.One 7fr ds sheath was returned for assessment at terumo medical corporation.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 separation 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).
Event or Problem Description
Additional information was received on 01jul2025: the vascular surgeon used her hands to remove the defective sheath out of the patient.The sheath was intact on the.035 wire already being used for the procedure.

• 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: 22160814
• Report Number: 1118880-2025-00076
• Device Sequence Number: 20688402
• Product Code: DYB
• UDI-Device Identifier: 00389701006192
• UDI-Public: (01)00389701006192(17)270601(10)0000817188
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2025

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 Model Number: RSR04
• Device Catalogue Number: RSR04
• Device Lot Number: 0000817188
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2024
• 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