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

Model Number	50-101
Medical Device Problem Codes	Difficult to Remove (1528); Retraction Problem (1536); Use of Device Problem (1670); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was returned to inari and subjected to visual inspection.The findings confirmed that the dilator hub had been cut by the physician as described, but there were no anomalies or device defects observed.The condition of the returned device precluded further analysis (e.G., dimensional analysis, performance testing).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 deployed in a vessel that was smaller than the manufacturer's recommendations.The device labeling lists the following contraindication: "not intended for use in vessels < 6 mm." (b)(4).
Event or Problem Description
A patient required 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.On the right side, the physician inserted the inari clottriever sheath, model 50-101, in the patient's right popliteal vein measuring 4-5 mm in diameter via venogram.After successfully deploying the funnel by advancing the dilator, the physician was unable to withdraw the dilator through the clottriever sheath.The physician retracted both the clottriever sheath and dilator until the sheath exited the vessel, but the dilator remained in the vessel.The physician intervened to cut the dilator hub, then withdrew the clottriever sheath from the access site.Using a 14 fr sheath, the physician was able to successfully remove the dilator from the patient without damaging the vessel.

• Brand Name: CLOTTRIEVER SHEATH
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): INARI MEDICAL, INC.; 9272 jeronimo road; suite 124; irvine CA 92618
• MDR Report Key: 7083936
• Report Number: 3011525976-2017-00002
• Device Sequence Number: 19141155
• Product Code: DXE
• UDI-Device Identifier: 00850291007109
• UDI-Public: 00850291007109
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K163549
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2017

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?: No
• Operator of Device: Physician
• Device Expiration Date: 05/30/2018
• Device Model Number: 50-101
• Device Lot Number: 17050006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Weight: 69