MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION DESTINATION RENAL GUIDING SHEATH; INTRODUCER, CATHETER

Model Number	RSR01
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
The user facility reported that when they were removing the 6fr 45cm destination sheath it had got stuck in the patient's femoral artery.The patient was not harmed.
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 6fr destination sheath was returned for assessment at terumo medical corporation.The sheath was subjected to visual analysis.It was separated 25 cm from the hub, with the coil stretched out in the separated region until it connects with the other half of the sheath.The complaint can be confirmed for sheath separation based on the status of the returned device.The exact root cause could not be determined.The likely root cause of the sheath separation is that the sheath experienced high tensional forces during withdrawal from the patient's femoral artery, causing it to separate.The destination ifu was reviewed (rfin0086 effective date 11/20/2019) and the following was found to guide the user: "caution: advance or withdraw the sheath slowly.If resistance is met, do not advance or withdraw the sheath until the cause of resistance has been determined."review of 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 hazard based risk table (hbrt).

• Brand Name: DESTINATION RENAL 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: stephanie handy ; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 20360901
• Report Number: 1118880-2024-00150
• Device Sequence Number: 15452721
• Product Code: DYB
• UDI-Device Identifier: 00389701006161
• UDI-Public: (01)00389701006161(17)261001(10)0000561012
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K172995
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2024

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: 10/01/2026
• Device Model Number: RSR01
• Device Catalogue Number: RSR01
• Device Lot Number: 0000561012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 10/03/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2024
• 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