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

Model Number	N/A
Medical Device Problem Codes	Leak/Splash (1354); Material Deformation (2976)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	07/26/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of birth - requested, not provided.Weight - requested, not provided.Ethnicity - requested, not provided.Race - requested, not provided.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation- assistant ward manager.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 an 8fr destination sheath was inserted with the dilator into the stroke patient.When removing the dilator from the sheath, the dilator got stuck to valve.The valve ruptured and caused bleeding.When replacing the new sheath within 5 minutes the patient had a hematoma in the groin.The user stated that the dilator was in the center of the valve.The patient had minor harm.Part of the hemostasis valve was caught on the dilator and detached from the introducer.The patient was hospitalized.Additional information was received on (b)(6) 2022: the estimated blood loss was 250cc.The bleeding was stopped by pressing the puncture area by hands and changing the new introducer over the wire.The patient was treated as intended.Additional information was received on (b)(6) 2022: the procedure performed was for a stroke in the brain.The patient was stable, and the procedure was completed successfully.The blood loss was approximately 250cc.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.2 to update section h3, and to provide the completed investigation results.One 8fr destination sheath and dilator were returned for product evaluation.No visual abnormalities were present on the length of the sheath or dilator.The hub of the sheath was disassembled with the valve and cap lodged into the hub of the dilator.The weld was examined on the ccv valve and weld residue appeared incomplete.Dimensional testing was performed.The outer diameter of the dilator was measured to be 0.110", and the specification is 0.113".All measurements were within the manufacturing specifications.The complaint can be confirmed for valve mechanical damage based on the condition of the returned device.The weld residue pattern on the valve suggested that the weld was not properly formed.This was likely the root cause of the valve coming apart when the dilator withdrew, as without a proper weld less force would be required to disassemble it.A non-conformance report (nc) was opened to address the incomplete valve seal.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date in section d9 and to update section h3.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.

• Brand Name: DESTINATION CAROTID 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: 15263418
• Report Number: 1118880-2022-00061
• Device Sequence Number: 5974669
• Product Code: DYB
• UDI-Device Identifier: 00389701009452
• UDI-Public: 00389701009452
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/19/2022

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: 05/01/2024
• Device Model Number: N/A
• Device Catalogue Number: 54-89001
• Device Lot Number: 0000121781
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2022
• Supplement Date Received by Manufacturer: 08/19/2022; 09/21/2022
• Initial Report FDA Received Date: 08/20/2022
• Supplement Report FDA Received Date: 09/16/2022; 09/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2021
• 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: 0.035 TERUMO GUIDEWIRE M.
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 63 YR
• Patient Sex: Male