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

Model Number	GS-R6ST1C12W
Medical Device Problem Codes	Unraveled Material (1664); Failure to Advance (2524)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Cramp(s) /Muscle Spasm(s) (4521)
Date of Event	12/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Terumo medical corporation received the reported information.The device was partway in the patient's forearm, and an attempt was made to pull the device out.However, the device started to unravel due to spasm.The patient was taken to surgery to remove the short part of sheath left in the forearm.The patient was stable when they left for surgery.The blood loss was less than 250cc.The device unraveled/braided coil when got stuck spasm within the radial artery.Additional information was received on 27dec2025: the type of procedure that was being performed was a left radial peripheral r2p case.The medication that was given to treat the spasm was nitro.The patient has underlying health conditions of peripheral artery disease (pad).The patient was stable following the surgery.The general surgeon removed second sheath and wire when other physicians were out of the room.When the first sheath was removed it started to unravel.There were no concomitant devices used with the sheath.
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.This report is for the second device reported, for the first device reported that was used on the same patient see mdr 1118880-2025-00193.
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 r2p sheath and dilator were returned for assessment.The sample was subjected to visual analysis.The dilator is fully inserted into the sheath.The sheath coil is separated 16.5cm from the sheath tip.The coil is separating from the sheath coating.One r2p sheath and dilator were returned for assessment, and the sheath was separated near the sheath tip.The complaint can be confirmed for a sheath separation.The exact root cause cannot be determined.The likely cause is the sheath was withdrawn during resistance due to patient spasm.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).

• 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: 24039459
• Report Number: 1118880-2025-00194
• Device Sequence Number: 10276783
• Product Code: DYB
• UDI-Device Identifier: 00389701011547
• UDI-Public: (01)00389701011547(17)280401(10)0001365414
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K193125
• 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): 01/12/2026

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: 0001365414
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 02/02/2026
• Initial Report FDA Received Date: 01/12/2026
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2025
• 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; Other
• Patient Sex: Unknown