MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION R2P DESTINATION SLENDER; INTRODUCER, CATHETER

Model Number	GS-R6ST1C12W
Medical Device Problem Codes	Difficult to Remove (1528); Unraveled Material (1664)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/28/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical received a medsun voluntary report (report number (b)(4)) stating that during removal of a left radial artery sheath, the sheath began to unravel and break.The issue occurred at the conclusion of a peripheral vascular angioplasty procedure.The device reportedly failed to function as intended and experienced a malfunction during removal.The procedure was completed as intended; however, the patient required surgical intervention to remove fragments of the device.Additional information received on 14 aug 2025: the complete date of the event was 28 jul 2025.Fragments were surgically removed after the sheath began to unravel and break.The patient was not harmed, and blood loss was not more than expected.The patient remained stable.No tortuosity or spasm was present in the patient's anatomy at the time of the event.
Additional Manufacturer Narrative
A1: patient identifier: requested, not provided.A2: date of birth: requested, not provided.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.The actual device is not available for return; therefore, an evaluation of the device could not be conducted.The complaint cannot be confirmed for a sheath breakage because a sample was not returned for assessment.Without a sample, the exact root cause cannot be determined.The device history record was reviewed to ensure that 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 the hazard based risk table (hbrt).
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to correct section g3.Upon internal review it was found that the g3 date (14-aug-2025) on mdr 1118880-2025-00130 was incorrect; therefore, a correction is being made.

• Brand Name: R2P DESTINATION SLENDER
• 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: 23047511
• Report Number: 1118880-2025-00130
• Device Sequence Number: 9809356
• Product Code: DYB
• UDI-Device Identifier: 00389701011547
• UDI-Public: (01)00389701011547(17)270901(10)0001036317
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• PMA/510(K) Number: K152525K1931
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2025

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: GS-R6ST1C12W
• Device Catalogue Number: GS-R6ST1C12W
• Device Lot Number: 0001036317
• 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: 08/14/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 09/13/2025
• Supplement Report FDA Received Date: 03/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/14/2025
• 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 Age: 74 YR
• Patient Sex: Male
• Patient Weight: 63 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White