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); Difficult to Remove (1528); Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Discomfort (2330); Vascular Dissection (3160); Device Embedded In Tissue or Plaque (3165)
Date of Event	02/01/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
A male patient with deep vein thrombosis (dvt) in the left lower extremity underwent a thrombectomy with the inari clottriever system on (b)(6)2024.The clot age was estimated at 2 days.After the guidewire was placed, the clottriever 13fr sheath (ct sheath) and clottriever bold catheter (ct bold) were advanced into position.Six passes were performed which yielded small amounts of clot.A venogram revealed moderate clot clearance and the physician planned to perform 2-3 more passes before ending the case.However, the physician experienced extreme resistance when retracting the ct bold catheter in the mid-femoral vein.The patient reported experiencing significant discomfort.The physician was able to slowly position the coring element into the funnel, but it would not go further.An attempt was made to remove the ct sheath and the ct bold catheter together, but this was not possible.Review of the computer tomography scan revealed that the ct bold had likely captured calcium that was present at the origin of the left common iliac vein.Unfortunately, the ct bold broke from the stress induced by excessive manipulation during removal attempts.A small venous cutdown was performed and the entire ct bold was able to be removed without incident.The consistency of the clot was described as densely calcified.A 10 fr sheath was inserted into the cutdown, over the wire, to confirm the vein was not damaged in the femoral region and the physician proceeded to close the incision site at the popliteal vein.The thrombectomy removed 90% of the dvt.The patient was evaluated the following day and scheduled for discharge soon after.
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.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 patient's venous cutdown was the result of device entrapment in the vessel.The dense calcium deposits in the treatment area and inadvertent user error likely contributed.The device labeling includes the following contraindication: not indicated for the removal of fibrous, adherent, or calcified material (e.G., atherosclerotic plaque).The device instructions for use includes the following warning statement: "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." vessel dissection/perforation are identified in the labeling as a possible adverse event/complication.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: 18823152
• Report Number: 3020347218-2024-00011
• Device Sequence Number: 4462250
• Product Code: QEW
• UDI-Device Identifier: 00850291007314
• UDI-Public: 00850291007314
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/01/2024

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: 10/23/2025
• Device Model Number: 42-102
• Device Lot Number: 23100071
• 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: 02/01/2024
• Initial Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/10/2023
• 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: 5X40 BALLOON; AMPLATZ SUPER STIFF GUIDEWIRE; CLOTTRIEVER SHEATH 13 FR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male