MAUDE Adverse Event Report: Inari Medical, Inc. ClotTriever BOLD Catheter, 6-16mm, 12Fr, 80cm; Peripheral Mechanical Thrombectomy With Aspiration

Model Number	42-102
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/30/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6)2026, a 65-year-old male patient underwent deep vein thrombosis (dvt) using stryker pv devices.During the procedure the clot-capturing portion of the device became overloaded with chronic clot.This resulted in additional surgery to remove the device.There were no other reported consequences to the patient.
Additional Manufacturer Narrative
The stryker pv devices were discarded by the user facility and are not available for evaluation.The device identifiers were provided, and the lot history records were reviewed.There were no discrepancies or unusual findings.Additionally, a complaint history review was conducted, and no similar issues have been reported against this lot number.The am confirmed that the clot collection element was overloaded with chronic clot, which is why it could not be withdrawn through the sheath.The pictures provided are consistent with this failure mode.The ifu does include the contraindication: not indicated for the removal of predominantly fibrous, firmly adherent, or calcified material (e.G., atherosclerotic plaque); which may apply to the case, and the failure mode is addressed in the dfmea.The available information reasonably suggests the stryker pv device likely contributed to the patient's need for a venous cutdown.Manufacturer reference number: (b)(4).

• Brand Name: ClotTriever BOLD Catheter, 6-16mm, 12Fr, 80cm
• Common Device Name: Peripheral Mechanical Thrombectomy With Aspiration
• Manufacturer (Section D): Inari Medical, Inc.; 6001 oak canyon; suite 100; irvine CA 92618
• Manufacturer (Section G): Inari Medical, Inc.; 6001 oak canyon; suite 100; irvine CA 92618
• Manufacturer Contact: james bennett ; 6001 oak canyon; suite 100; irvine, CA 92618 ; +1(949)413-2147
• MDR Report Key: 50442047
• Report Number: 3020347218-2026-00064
• Device Sequence Number: 9763017
• Product Code: QEW
• UDI-Device Identifier: 00810123710393
• UDI-Public: (01)00810123710393(17)271014(10)25100072
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K230494
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 42-102
• Device Catalogue Number: 42-102
• Device Lot Number: 25100072
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 07/30/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/14/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Sex: Male