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

Model Number	N/A
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: lead rt.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 involved destination slender sheath was inserted into the patient's arm, when the physician noticed what was described as a barb in mid shaft.The physician stopped inserting and removed the sheath.There were no adverse events as a result.The procedure was a success, and the patient condition is stable.Procedure performed for the patient was a celiac artery angiogram.No blood loss was reported.No patient injury and/or required medical or surgical intervention.There is not a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.The event occurred intra-operative.Additional information was received on 12 feb 2024: the case was completed successfully without using the sheath.Catheter use only.
Additional Manufacturer Narrative
One r2p sheath and dilator assembly was returned to terumo medical corporation for assessment.The sample was subject to visual analysis.There are no damage or deformities on the dilator.There is no damage on the sheath along the length of the sheath or near the hub.The sheath tip is deformed.The complaint can be confirmed for sheath tip deformation.The exact root cause cannot be determined.The likely root cause is the sheath tip deformed during insertion into the vessel.The sheath did not have any damage or uncoiling along the sheath as stated in the complaint description.Review of device history records 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: 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 ; 6402040886
• MDR Report Key: 18871764
• Report Number: 1118880-2024-00024
• Device Sequence Number: 2970281
• Product Code: DYB
• UDI-Device Identifier: 00389701012377
• UDI-Public: 00389701012377
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/01/2025
• Device Model Number: N/A
• Device Catalogue Number: GS-R6ST1C85W
• Device Lot Number: 0000359626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2023
• 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
• Patient Sex: Unknown