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	Use of Device Problem (1670)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The inari 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 case was reviewed by inari stryker medical affairs, who concluded that the patient¿s injury was likely the result of user error (not collapsing the bag before removing).The device labeling includes the following instructions."6.Retract and rotate the knob of the handle plunger clockwise to unlock it and release the plunger to close the collection bag with the thrombus.Note: if a vessel stricture or stenosis is encountered during retraction that reduces the vessel lumen to less than 6 mm, release the plunger as described in step 6 to relieve tension on the coring element prior to retracting the coring element through the stricture.After the coring element safely passes the stricture, retract the handle plunger back until it stops and rotate the knob counterclockwise to lock it in place.In the event the coring element is still unable to pass the vessel stricture, release the handle plunger, uncouple the spin lock on the handle and advance the outer shaft to re-constrain the coring element.7.Press the hemostasis valve buttons on the sheath and retract the clottriever bold catheter from the sheath.After removing the clottriever bold catheter from the sheath, release the valve buttons to minimize blood loss." the device labeling includes the following warning: "avoid using excessive force to advance or retract against resistance.If excessive resistance is encountered, retract, and collapse the collection bag and coring element into the outer catheter and remove the device.Excessive force against resistance may result in damage to the device or vessel." the device labeling lists vessel dissection as a possible adverse event/complication.Manufacturer reference number: (b)(4).
Event or Problem Description
On (b)(6) 2025, a 39-year-old female patient underwent deep vein thrombosis (dvt) thrombectomy using inari devices.During the thrombectomy, the clottriever bold catheter (ct bold) was removed through the sheath without collapsing the coring element.Upon the next pass, resistance was felt when opening the coring element.The coring element was collapsed to remove the device on the second pass, however, it appeared that part of the patient's vein was on the ct bold collection bag, though no extravasation was noted.A different device was used to complete the case without further issues.

• 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 ; 9494132147
• MDR Report Key: 23651956
• Report Number: 3020347218-2025-00086
• Device Sequence Number: 15943068
• Product Code: QEW
• UDI-Device Identifier: 00810123710393
• UDI-Public: (01)00810123710393(17)270911(10)25090048
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 11/25/2025

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: 25090048
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/30/2025
• Initial Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/11/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 39 YR
• Patient Sex: Female
• Patient Weight: 82 KG