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

Model Number	42-102
Medical Device Problem Codes	Entrapment of Device (1212); Use of Device Problem (1670)
Health Effect - Clinical Codes	Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)
Date of Event	01/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
An (b)(6) male patient with a preexisting deep vein thrombosis (dvt) in the left lower extremity underwent a thrombectomy on (b)(6) 2024 using the clottriever system.The clot age was estimated at 21 days.The patient was placed in the prone position and left popliteal access was obtained.Intravenous ultrasound (ivus) was performed which revealed venous compression and thrombus.The clottriever sheath 13 fr and clottriever bold catheter (ct bold) were placed into position.Four passes were made with the ct bold which removed long chronic clot.An abre 16x20 venous stent was placed and ballooned with a 16x40 balloon.A venogram revealed 90% of the dvt was removed, with thrombus remaining below the stent.A flowtriever 2 was used distal from the stent and two passes were performed, however, no clot was removed.The ct bold was then advanced into the stent with the collection bag positioned in the stent and the coring element below the stent.A pass was performed, but no clot was removed.Another pass was performed, but the top of the stent was inadvertently pulled down over itself.The procedure was paused to re-sheath the ct bold; however, multiple attempts were unsuccessful.The patient was repositioned supine to access the left femoral vein below the stent.The ct bold sheath was placed below the stent and a multipurpose catheter with benson guidewire was placed through the stent.A balloon 10x40mm dilated stent was used to open the proximal end.After a few dilations, the ct bold was advanced to re-sheath the collection bag.Most of the catheter was re-sheathed except for a small segment.The patient was transferred to another hospital where a cut-down was performed in the femoral vein to remove the ct bold catheter.The venous cutdown was successful, the catheter was removed intact, and the patient was reported to be doing well postoperatively.
Additional Manufacturer Narrative
The inari device was discarded by the hospital and is not available for evaluation.The device identifiers were provided, and the lot history records were reviewed.There were no discrepancies or unusual findings.Based on the information reviewed, there is no evidence to indicate the presence of a potential quality issue with respect to manufacturing, design, or labeling.The case was reviewed by inari's chief medical officer, who concluded that the event (catheter embedded in femoral vein and stent issue) and subsequent need for surgical intervention (hospital transfer for venous cutdown) were the result of inadvertent user error when working in the area of the stent.The device labeling includes the following warning statement, "when the clottriever bold device is in the path of a stent, damage to the stent, the collection bag, or dislodgment of the stent, etc.May occur." vessel dissection/perforation are listed in the device labeling as potential complications / adverse events.Manufacturer reference #: (b)(4).

• 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
• Manufacturer (Section G): INARI MEDICAL, INC.; 6001 oak canyon; suite 100; irvine CA 92618
• Manufacturer Contact: keith hebert ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 6513233614
• MDR Report Key: 18665261
• Report Number: 3020347218-2024-00006
• Device Sequence Number: 8357665
• Product Code: QEW
• UDI-Device Identifier: 00850291007314
• UDI-Public: 00850291007314
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/07/2024

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: 07/18/2025
• Device Model Number: 42-102
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/16/2023
• 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: ABRE 16X20 VENOUS STENT; BENSON GUIDEWIRE; CLOTTRIEVER SHEATH 13 FR; FLOWTRIEVER 2; GLIDEWIRE ADVANTAGE; JR4
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male