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

Model Number	GS-R6ST1C75W
Medical Device Problem Codes	Break (1069); Unraveled Material (1664); Obstruction of Flow (2423); Failure to Advance (2524)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/16/2025
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 (b)(6) 2025, a nurse from the cardiac cath lab called to say that the destination slender sheath had ''snapped off'' and ''unraveled'' in the patient's arm.He stated that the patient was stable and would be transferred to surgery for repair.The type of procedure was a cardiac catheterization.The blood loss was less than 250cc.The injury was described as surgical repair of the artery.Additional information was received on 20may2025: standard radial access was gained with a 6 french 10cm glidesheath slender.The physician was unable to advance a catheter past the forearm; therefore, decided to introduce the destination slender.The destination slender stopped at the same point in the forearm as the catheter; therefore, the physician converted to groin access.The destination slender was left in the radial artery for the duration of the procedure.Upon attempted removal of the destination slender, it would not move.The physician was unable to deliver radial cocktail.There was no bleed back or aspiration from the sheath.The medical doctor (md) stated that the dilator and a wire were then inserted to assist with removal, without success.The physician then noted that the destination slender had started to unravel at this point.The patient was then transferred to surgery for successful cut down and removal of the destination slender.The patient tolerated surgery well and was discharged without further incident on sunday, (b)(6) 2025.Additional information was received on 23may2025: only one device was involved.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide patient demographics to section a, update section h3, and to provide the completed investigation results.One r2p sheath and dilator were returned for product evaluation.The sample was subject to visual analysis.The dilator is partially inserted into the sheath and cannot be removed.The sheath is broken 76.4 cm from the sheath hub.The broken piece is 9.3 cm long.The sheath is separated near the sheath hub.The separated piece of sheath was returned with the sample.The complaint can be confirmed for a sheath breakage.The exact root cause cannot be determined.The likely cause is the sheath encountered resistance during withdraw.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: 22143431
• Report Number: 1118880-2025-00075
• Device Sequence Number: 8216151
• Product Code: DYB
• UDI-Device Identifier: 00389701012360
• UDI-Public: (01)00389701012360(17)270701(10)0000865912
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2025

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-R6ST1C75W
• Device Catalogue Number: GS-R6ST1C75W
• Device Lot Number: 0000865912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Supplement Date Received by Manufacturer: 07/01/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2025
• 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 Age: 64 YR
• Patient Sex: Male