MAUDE Adverse Event Report: TERUMO CLINICAL SUPPLY CO., LTD. PRIORITYONE; ASPIRATION THROMBECTOMY CATHETER

Model Number	UG1602
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/13/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported the aspiration catheter, priority one, was used for a thrombectomy.Multiple attempts were successful (5-6 times).There was more clot distally, so they advanced the catheter but stuck.When pulling it, the catheter's tip dislodged in the left main.An attempt to extract the fragment was made without success, then it migrated to the thorax.

• Brand Name: PRIORITYONE
• Common Device Name: ASPIRATION THROMBECTOMY CATHETER
• Manufacturer (Section D): TERUMO CLINICAL SUPPLY CO., LTD.; 3 kawashima-takehayamachi; kakamigahara; gifu, 501-6 024; JA 501-6024
• MDR Report Key: 19786023
• Report Number: 2243441-2024-00021
• Device Sequence Number: 8655049
• Product Code: QEZ
• UDI-Device Identifier: 04543334177254
• UDI-Public: 04543334177254
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/19/2024
• Report Date (Section F): 07/19/2024

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: 07/31/2026
• Device Model Number: UG1602
• Device Catalogue Number: 30-6100
• Device Lot Number: 230700660
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/15/2024
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/19/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/19/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 07/19/2024