MAUDE Adverse Event Report: INARI MEDICAL, INC. CLOTTRIEVER CATHETER; EMBOLECTOMY CATHETER

Model Number 40-102

Device Problems Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017); Device-Device Incompatibility (2919); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2017

Event Type  Injury  

Manufacturer Narrative

The device was discarded by the user and is not available for evaluation.The device history records were reviewed for this manufacturing lot and there were no anomalies, discrepancies, or non-conformances.The root cause of the event was believed to be related to use error where the device was advanced despite resistance resulting in the device buckling into the ivc becoming entangled with the patient's existing ivc filter.The device labeling includes the following warning statements: "when used in patients with an ivc filter, damage to the filter, the collection bag, or dislodgement of the ivc filter, etc.May occur." "avoid using excessive force to advance or retract against resistance.If excessive resistance occurs, retract and collapse the collection bag and coring element into the clottriever outer catheter and remove the device.Excessive force against resistance may result in damage to the device or vessel perforation." related to mdr #3011525976-2017-00002.(b)(4).

Event Description

A patient required additional intervention to treat bilateral deep vein thrombosis (dvt) after previous angiojet and 24-hour tpa drip using ekos device.The physician successfully treated the patient's left dvt by aspiration with an 8 fr catheter.Due to the presence of a cordis optease vena cava filter, the surgical plan to treat the right dvt was to go up and over the bifurcation via the left leg.On the right side, the physician inserted clottriever sheath into vein to (popliteal vein) over a pre-placed 0.035" guidewire in patient's left leg.The physician experienced difficulty deploying the funnel until manipulated into a larger zone.The dilator was then removed.The physician reports that he did not experience resistance as he advanced the clottriever catheter along the guidewire over the bifurcation.He reports feeling resistance immediately past the common iliac vein and deep femoral vein (profunda) and could not advance the tip beyond the iliac vein.The physician forced the catheter and pushed slightly past the profunda to the proximal femoral vein.The clottriever catheter seemed to advance in the physician's hands, but not distally on fluoroscopy.The clottriever catheter's net was exposed, but would not expand.The guidewire and clottriever catheter net were arched up into the inferior vena cava (ivc).The net could be seen extending into the ivc and into the existing ivc filter where it became caught in the barbs of the inferior portion of the ivc filter.Retraction/manipulation was unsuccessful in freeing the clottriever catheter, therefore, the physician inserted a balloon and advanced to a site between the ivc filter and the clottriever catheter net and the dilated balloon was then able to free the clottriever catheter from the ivc filter.The clottriever catheter was removed successfully and an 8 fr multi-purpose catheter was used to remove the remaining clot.Post-procedure venogram showed clear vessels with no vessel leakage or ruptures and the case was completed without incident.No hematomas were noted postoperatively and the patient reports feeling fine.

• Brand Name: CLOTTRIEVER CATHETER
• Type of Device: EMBOLECTOMY CATHETER
• Manufacturer (Section D): INARI MEDICAL, INC.; 9272 jeronimo road; suite 124; irvine CA 92618
• Manufacturer (Section G): INARI MEDICAL, INC.; 9272 jeronimo road; suite 124; irvine CA 92618
• Manufacturer Contact: eben gordon ; 9272 jeronimo road; suite 124; irvine, CA 92618 ; 9496008433
• MDR Report Key: 7084991
• MDR Text Key: 93803613
• Report Number: 3011525976-2017-00003
• Device Sequence Number: 1
• Product Code: DXE
• UDI-Device Identifier: 00850291007093
• UDI-Public: 00850291007093
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163549
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/30/2018
• Device Model Number: 40-102
• Device Lot Number: 17050007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 69