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

Model Number	GS-R6ST1C15W
Medical Device Problem Codes	Stretched (1601); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.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 that during a percutaneous transluminal angioplasty (pta) and stenting procedure of the right superficial femoral artery (sfa), a 149 cm destination slender sheath was inserted through the right radial artery and advanced into the proximal right sfa.After wiring, ballooning, and stenting of the right sfa, the physician prepared to remove the sheath and inserted a 0.035-inch guidewire into it.The physician was advised to insert the dilator into the sheath prior to removal to help prevent elongation if resistance was encountered.The physician acknowledged that this step is included in the instructions for use (ifu), but stated that, based on prior experience, inserting the dilator tends to cause more complications than removing the sheath over the guidewire alone.While pulling back the sheath, resistance was encountered and the physician continued pulling, which caused the sheath to elongate.The physician then inserted the dilator and resumed pulling, but the sheath continued to elongate.Vascular surgery was consulted.The sheath was cut just proximal to the insertion site to allow for sterile dressing application.The patient was transferred to another facility for emergency surgical removal of the retained sheath.The estimated blood loss was less than 250 cc.The event resulted in patient injury and required medical and surgical intervention.Additional information was received on 03 jun 2025: it was reported that the patient was doing well following surgery.It is believed that a glidewire advantage guidewire was present in the sheath during the removal attempt.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section h3 and to provide the completed investigation results.One r2p sheath and dilator were returned for assessment.The sample was subject to visual analysis.The sheath is broken 3.1cm from the sheath hub.The sheath is uncoiling 37.1cm from the sheath hub.The complaint can be confirmed for a sheath breakage.The exact root cause cannot be determined.The likely cause is increased resistance during withdrawal.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.No previous corrective and preventative action (capa) or non-conformances (nc) were noted for this issue in the past year.

• 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: 22350488
• Report Number: 1118880-2025-00083
• Device Sequence Number: 4799589
• Product Code: DYB
• UDI-Device Identifier: 00389701011561
• UDI-Public: (01)00389701011561(17)260601(10)0000466235
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 06/27/2025

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 Expiration Date: 06/01/2026
• Device Model Number: GS-R6ST1C15W
• Device Catalogue Number: GS-R6ST1C15W
• Device Lot Number: 0000466235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/14/2023
• 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 Age: 73 YR
• Patient Sex: Female
• Patient Weight: 66 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White