MAUDE Adverse Event Report: INARI MEDICAL, INC. TRIEVER16; PERIPHERAL MECHANICAL THROMBECTOMY WITH ASPIRATION

Model Number	25-101
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been returned to the manufacturer for evaluation.Visual inspection of the triever16 (t16) revealed a complete separation of the catheter shaft approximately 15.50 inches from the distal end of the catheter.This location approximately corresponds to the length of the 35d pebax section and the coil/braid overlap region.The 35d pebax outer layer, ptfe liner, and stainless steel coil were fully sheared, resulting in a complete disconnection between the proximal and distal segments of the catheter.The catheter most likely separated due to excessive manipulation during use.Application of undue force while advancing or retracting the device against resistance, particularly in tortuous anatomy, can compromise catheter integrity.Manipulating the t16 catheter after being used during in the procedure likely contributed to the observed separation in the returned device.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 device labeling includes the following warnings: "avoid using excessive force to advance or retract against resistance.If excessive resistance occurs, retract, and collapse the distal disks into the catheter and remove the device.Excessive force against resistance may result in damage to the device or vessel perforation." "excess pressure may result in catheter damage or patient injury." manufacturer reference: (b)(4).
Event or Problem Description
On (b)(6) 2025, a 42-year-old male underwent deep vein thrombosis (dvt) and pulmonary embolism (pe) thrombectomy using inari devices.While the triever16 (t16) was being prepared for another pass, the technician adjusted a bend in the t16 catheter, and the catheter subsequently separated.A new device was opened, and the case was completed without further issues.

• Brand Name: TRIEVER16
• 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: mazi kiani ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 6513233614
• MDR Report Key: 22178365
• Report Number: 3020347218-2025-00039
• Device Sequence Number: 8678486
• Product Code: QEW
• UDI-Device Identifier: 00850291007130
• UDI-Public: (01)00850291007130(17)261106(10)24110026
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K223419
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/10/2025

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: 25-101
• Device Lot Number: 24110026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2025
• Initial Report FDA Received Date: 06/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• 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: FLOWSAVER; FLOWTRIEVER L CATHETER; FLOWTRIEVER M CATHETER; INTRI24 SHEATH; TREIVER24; VENACORE CATHETER
• Patient Age: 42 YR
• Patient Sex: Male
• Patient Weight: 68 KG