MAUDE Adverse Event Report: INARI MEDICAL INC CLOTTRIEVER BOLD CATHETER; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	42-102
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	03/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
During a left lower extremity (lle) thrombectomy stenting, the line would not retract back up thru the purple line.

• Brand Name: CLOTTRIEVER BOLD CATHETER
• Common Device Name: PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION
• Manufacturer (Section D): INARI MEDICAL INC; 6001 oak canyon, suite 100; irvine CA 92618
• MDR Report Key: 19613500
• Report Number: 19613500
• Device Sequence Number: 6974755
• Product Code: QEW
• UDI-Device Identifier: 00850291007314
• UDI-Public: (01)00850291007314
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2024
• Report Date (Section F): 04/02/2024

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 Model Number: 42-102
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Female
• Patient Weight: 77 KG
• Patient Race: White
• Date Report Sent to FDA: 04/02/2024