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

Model Number	10-103
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/12/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The flowtriever is being returned to the manufacturer for evaluation.The findings will be submitted in a follow-up report.The event was reviewed by inari's chief medical officer, who concluded that the detached marker was the result of device malfunction.Manufacturer reference #: (b)(4).
Event or Problem Description
A 51-year-old female patient underwent bowel surgery 2 months ago and after being discharged, the patient was very inactive and developed a bilateral pulmonary embolism (pe).A computed tomography (ct) scan revealed the main clot burden was in the right pulmonary artery (interlobar and truncus anterior) with a little on the left side.The patient underwent a thrombectomy procedure with the inari flowtriever system on (b)(6) 2023.Nine aspirations were performed with the inari triever24 (t24) which cleared the majority of clot on the right.The physician then repositioned the t24 to the main pulmonary artery and performed 3 subsequent aspirations.An angiogram was then performed which showed some remaining clot and the physician decided to use the inari flowtriever (ft) l disks to address the remaining clot.The disks were advanced without issue and once the physician located the radiopaque marker behind the clot, the physician began retracting the delivery system.However, the disks did not open as expected and remained relatively flat.A second attempt was made to insert the disks into the delivery system, but the radiopaque marker inadvertently detached from the ft l disk and went more distal over the guidewire.The wire connection was then lost.The physician attempted to aspirate the marker using the t24, but was unsuccessful; additional attempts were made with an inari triever16 and a new t24 device.Unfortunately, all attempts to aspirate were unsuccessful.The physician then attempted to snare the marker with an amplatz goose neck 175 cm snare length with 4 mm loop diameter and a 175 cm snare with 7 mm loop diameter, but both attempts were unsuccessful.The physician then advanced a balanced middleweight coronary guidewire through a 6 fr jr4 and wired successfully through the radiopaque marker.A maverick 3.0 x 15 mm balloon was then advanced through the marker and inflated.Everything was then pulled back through the sheath and the marker was removed successfully and completely.The patient was stable and transferred to the icu.No patient injury occurred and 85% of the clot was removed.Follow-up status was requested and the patient is doing well and was discharged from the hospital.
Additional Manufacturer Narrative
The flowtriever (ft) catheter, l, along with ancillary (products not manufactured by inari) were returned to the manufacturer for evaluation.The ft catheter was subjected to visual inspection, microscopic inspection, dimensional analysis, and root cause analysis.Visual examination of the distal end of braided disks (ft catheter) revealed no defects.Examination of the maverick2 balloon catheter identified a cut approximately 4" proximal to the ft catheter tip.The tip/balloon were moved to the keyence for microscopic imaging which revealed the gate on the tip was no longer visible indicating that fusing occurred.An inward arc was visible on the edges of the tip further confirming that fusing occurred.The ft catheter was then removed from the balloon catheter and sliced axially to expose the inside of the ft catheter tip.The resulting halves were then inspected under the keyence.Imprints were seen of the braid indicating that the braid was inserted when fusing occurred.Subsequent testing was performed to attempt to replicate the failure mode.Review of the device history records for this manufacturing lot did not identify an out of specification condition.However, the root cause analysis led to the conclusion that the ft catheter bond between the braid and the distal tip was inferior which allowed the distal tip to become separated from the device intraoperatively.Because this fuse was not fully formed, it is inferred that there was less support than normal and may have led to the failure.The summary of the case states that the tip came off when attempting to insert the disks into the delivery system.However, it is unclear why the ft disks did not deploy correctly.Based on our knowledge and experience with the device, it is reasonable to assume that excessive force was applied when trying to re-sheath the disks.When coupled with the inferior bond, additional force likely resulted in the tip dislodging from the tip from the device.The device labeling includes the following warning statement: 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.

• Brand Name: FLOWTRIEVER CATHETER, L
• 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: kit cariquitan ; 6001 oak canyon; suite 100; irvine, CA 92618 ; 8779234747
• MDR Report Key: 17206050
• Report Number: 3020347218-2023-00009
• Device Sequence Number: 14837825
• Product Code: QEW
• UDI-Device Identifier: 00850291007024
• UDI-Public: 00850291007024
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K211013
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2023

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: 01/19/2025
• Device Model Number: 10-103
• Device Lot Number: 23010080
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2023
• Supplement Date Received by Manufacturer: 07/25/2023
• Initial Report FDA Received Date: 06/26/2023
• Supplement Report FDA Received Date: 08/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2023
• 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: AMPLATZ SUPERSTIFF GUIDEWIRE 1 CM; CORDIS EMERALD ACCESS WIRE; INARI TRIEVER24 CATHETER; MAVERICK2 BALLOON CATHETER; SUPERTORQUE PIGTAIL CATHETER; TERUMO SHEATH 8 FR
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female