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

Model Number	RSR01
Medical Device Problem Code	Solder Joint Fracture (2324)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted, d6b: explanted date: device was not explanted, e2: health professional: requested, unknown, e3: occupation: vigilance correspondent.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.
Event or Problem Description
The user facility reported the breakage of the introducer during traction while removing the material.The patient sustained no injury.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update sections a2, a3, a4, b5, b7, and d10 with additional information and to provide the completed investigation results.One 6fr destination sheath was returned for assessment.The sheath was subjected to visual analysis.The sheath was separated with the coil holding the two separated pieces together.The separation was measured to occur 23.3 cm from the hub.The complaint can be confirmed for sheath separation based on the condition of the returned device.The exact root cause could not be determined.All destination kits undergo 100% inspection before shipping from terumo.The likely root cause is that withdrawing the sheath over the very calcified and artery caused the sheath to experience significant and tension, which led it to separate.Review of device history record (dhr) showed there were no issues noted during the manufacture of the product that could have contributed to this complaint condition.No ncs or capas were opened for this issue within the last 12 months.Currently, no action is recommended since the risk evaluation is within the predetermined limits in hazard based risk table (hbrt).
Event or Problem Description
Additional information received on 20 mar 2025: the procedure performed was a right femoral angioplasty with left femoral puncture and crossover.Despite an angulated aortic bifurcation, crossover was possible with no intraoperative vascular spasm.The patient had a surgical history of opposite puncture points with prosthetic material (patch).Simple manual removal was performed to extract the broken device, done manually and gently to avoid breaking the residual metal cable.A pre-deployment angiogram was performed, showing no loss of intravascular material.Blood loss was less than 50cc.The patient remained stable, and the procedure was completed successfully.Concomitant devices used were a viabahn gore stent before rupture and a ranger balloon.The device broke inside the patient, but there were no consequences for the patient or the procedure.Additional information received on 28 apr 2025: all pieces were removed from the patient during the procedure.
Additional Manufacturer Narrative
This report is being submitted as follow up no.2 to correct section g3.Upon internal review it was found that the g3 date (29-apr-2025) on mdr 1118880-2025-00039f was incorrect; therefore, a correction is being made.

• 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: 21569682
• Report Number: 1118880-2025-00039
• Device Sequence Number: 12923407
• Product Code: DYB
• UDI-Device Identifier: 00389701006161
• UDI-Public: (01)00389701006161(17)270201(10)0000681786
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 03/11/2025

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 Model Number: RSR01
• Device Catalogue Number: RSR01
• Device Lot Number: 0000681786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 04/29/2025; 03/20/2025
• Initial Report FDA Received Date: 03/11/2025
• Supplement Report FDA Received Date: 05/02/2025; 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: RANGER BALLOON.; VIABAHN GORE STENT.
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 67 KG