MAUDE Adverse Event Report: INARI MEDICAL FLOWTRIEVER ASPIRATION GUIDE CATHETHER; EMBOLECTOMY CATHETER

Model Number	21-101
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	07/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was discarded by the user and was not available for evaluation.The device history records were reviewed for this manufacturing lot and there were no anomalies, discrepancies, or non-conformances.There was no report of a device malfunction.Manufacturer reference #: (b)(4).
Event or Problem Description
The flowtriever procedure went very well.The inari aspiration guide catheter, 21-101, was inserted through a pre-placed 22 fr gore dryseal introducer sheath.Small (10-101) and a medium (10-102) flowtriever catheters were used on the left pulmonary artery to remove clot.At the end of the procedure, the sheath was pulled and a cath lab tech held pressure at the groin.When the patient left the cath lab the access site was clean and dry.Three days after discharge the patient reported swelling at the access site and returned to the hospital.Due to the hematoma that formed, the decision was made to surgically close the access site.

• Brand Name: FLOWTRIEVER ASPIRATION GUIDE CATHETHER
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): INARI MEDICAL; 9272 jeronimo road; suite 124; irvine CA 92618
• MDR Report Key: 6806535
• Report Number: 3011525976-2017-00001
• Device Sequence Number: 13699392
• Product Code: DXE
• UDI-Device Identifier: 00850291007079
• UDI-Public: 00850291007079
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K162970
• 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): 08/19/2017

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: 12/01/2017
• Device Model Number: 21-101
• Device Catalogue Number: 21-101
• Device Lot Number: 16120001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2017
• Initial Report FDA Received Date: 08/19/2017
• 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: 60 YR
• Patient Weight: 68