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

Model Number	GS-R6ST1C95W
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: supply chain manager.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 the patient was having a lower extremity angiogram via the left radial artery.At the end of the procedure the tr band was placed.While withdrawing the r2p destination slender, the sheath started to uncoil and became lodged in patient's radial artery.The patient needed to have an emergency cutdown to remove sheath.The dilator was in place for removal and the wire was used to remove sheath at the end of procedure.Additional information was received on 09jul2024: the patient was doing well; she went home later friday evening on 26jul2024.Additional information was received on 09aug2024: the pre-procedural condition of the patient was history of peripheral artery disease (pad) with known bypass.Initially they thought it was spasms, however after being completely anesthetized that did not help.They had to extend the cut down incision and dissect the radial artery to about 5-6cm proximal to the access point in order to release it from where it was stuck or hooked on the artery.The patient was doing well and went home that evening after a cut down and sheath removal.The estimated blood loss was less than 250cc.A 4mm balloon at the below knee (bk) pop anastomosis where the patient had a stenosis at her distal bypass.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide a correction to the date the additional information was received, previously it was inadvertently reported that the additional information was received on 09jul2024 when the correct date received was 29jul2024.Also to update section h3, and to provide the completed investigation results.One r2p sheath and dilator assembly was returned to terumo medical corporation for assessment.The sample was subject to visual analysis.The dilator is partially inserted into the sheath and cannot be removed.The sheath is fully separated, and the broken portion is 55.8cm long.The sheath is separated 74.2cm from the sheath hub.The sheath is stretched 10.7-25.4cm from the sheath hub.The sheath is flattened 53.9-64.1cm from the sheath hub.The sheath has kinks and uncoiling along the sheath.The complaint can be confirmed for sheath separation.The exact root cause cannot be determined.A meeting was held with the chief medical officer and determined the likely root cause is the sheath was withdrawn during resistance from a vessel spasm.Additionally, the user should have taken additional steps (sedation, vasodilation, warm compress) to alleviate the spasm before attempting removal of the sheath.The r2p ifu was reviewed, and it states: "caution: while inserting or withdrawing, if resistance is met, do not advance or withdraw the sheath until the cause of the resistance has been determined." review of dhr showed there were no issues noted during the manufacture of the product that could have contributed to this complaint condition.Currently no action is recommended since this risk evaluation is within the predetermined limits in the hazard based risk table (hbrt).
Event or Problem Description
Additional information was received on 29jul2024: the patient was doing well; she went home later friday evening on (b)(6) 2024.

• Brand Name: R2P¿ DESTINATION SLENDER¿ GUIDING SHEATH
• 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: gina digioia ; 950 elkton blvd; elkton, MD 21921 ; 4103927218
• MDR Report Key: 20061206
• Report Number: 1118880-2024-00126
• Device Sequence Number: 20743089
• Product Code: DYB
• UDI-Device Identifier: 00389701012384
• UDI-Public: (01)00389701012384(17)260701(10)0000486522
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2024

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: 07/01/2026
• Device Model Number: GS-R6ST1C95W
• Device Catalogue Number: GS-R6ST1C95W
• Device Lot Number: 0000486522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2024
• Supplement Date Received by Manufacturer: 09/12/2024
• Initial Report FDA Received Date: 08/25/2024
• Supplement Report FDA Received Date: 10/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/22/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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: 4MM BALLOON.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown