MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION R2P¿ DESTINATION SLENDER¿ GUIDING SHEATH

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Great Vessel Perforation (2152)
Date of Event	12/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that they had an r2p procedure to treat superficial femoral artery (sfa) disease.The physician went right radial and was able to successfully treat the superficial femoral artery (sfa) disease with a 119cm destination slender sheath.Physician went to remove the sheath over a 035 gwa where resistance was met.Physician continued to pull until the sheath separated and unraveled at the radial access site.A balloon was inserted and inflated multiple times inside and distal of the sheath to help with removal.The sheath continued to unravel.Ir and vascular surgeon were called to surgically remove the sheath.Unfortunately, the patient lost their right radial artery when the distal end of the sheath was removed.After the event the terumo field clinical specialist discussed proper destination slender removal techniques with the physician by reinserting the dilator every time especially when resistance is met.The patient was recovering in the intensive care unit (icu).The estimated blood loss was less than 250cc.
Additional Manufacturer Narrative
This report is being resubmitted since all of the acknowledgements were not initially received and was noted upon review.Esg help desk was contacted and provided the initial receipt from the inital submission, however they suggested to re-submit the report.A copy of the initial submission receipt is attached in the attachment section.A1: patient identifier: (b)(6).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.
Additional Manufacturer Narrative
This report is being resubmitted since it had initially failed due to the initial report not receiving all of the acknowledgements when it was initially submitted and received which was not noted until further review.Esg help desk was contacted and provided the initial receipt from the initial submission, and the follow up submission and they suggested to re-submit this report as well as the initial report.A copy of the original initial submission receipt and follow up submission receipt is attached in the attachment section.This report is being sent as follow-up no.1 to update section d9, section h3, and to provide the completed investigation results.The actual device has been returned for evaluation.One r2p sheath assembly was returned for product assessment.The sample was subject to visual analysis.The sheath is separated 60.4cm from the sheath hub.The sheath is stretched, and the coil is unraveling at multiple points along the sheath body.The complaint can be confirmed for sheath separation.The likely root cause is a patient spasm increased resistance during removal and led to sheath separation.The combination of not inserting the dilator for support and lack of vasodilators to alleviate spasm contributed to the separation.Review of device history record (dhr) showed there were no issues noted during 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 design failure mode and effects analysis (dfmea).

• Brand Name: R2P¿ DESTINATION SLENDER¿ GUIDING SHEATH
• Common Device Name: GUIDING SHEATH
• 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 ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 20818871
• Report Number: 1118880-2023-00462
• Device Sequence Number: 18353721
• Product Code: DYB
• UDI-Device Identifier: 00389701011547
• UDI-Public: 00389701011547
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K193125
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 01/04/2024

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: 03/01/2026
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C12W
• Device Lot Number: 0000422315
• 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: 12/05/2023
• Supplement Date Received by Manufacturer: 02/23/2024
• Initial Report FDA Received Date: 12/02/2024
• Supplement Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 035 150CM NAVICROSS.; 035 GLIDEWIRE ADVANTAGE.
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White