MAUDE Adverse Event Report: WALK VASCULAR, LLC JETI PERIPHERAL THROMBECTOMY SYSTEM; THROMBECTOMY CATHETER

Model Number	WV008F
Medical Device Problem Code	Off-Label Use (1494)
Health Effect - Clinical Code	Bradycardia (1751)
Date of Event	07/19/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The jeti peripheral thrombectomy system is intended to remove/aspirate fluid and break-up soft emboli and thrombus from the peripheral vasculature and to sub selectively infuse/deliver diagnostics or therapeutics with or without vessel occlusion.This particular procedure involved intervention into the inferior vena cava, which is not an approved indication for this device.Additional information was requested to the user facility, but no further details could be provided.The jeti peripheral thrombectomy system operated as intended with no device malfunction.
Event or Problem Description
An adverse event occurred after using the jeti peripheral thrombectomy system in (b)(6) usa.When the occlusion could not be completely removed within the inferior vena cava of the patient, an alternative device (argon cleaner) was utilized and the patient entered bradycardia approximately 10 minutes into the alternative procedure.

• Brand Name: JETI PERIPHERAL THROMBECTOMY SYSTEM
• Common Device Name: THROMBECTOMY CATHETER
• Manufacturer (Section D): WALK VASCULAR, LLC; 17171 daimler st.; irvine CA 92614
• MDR Report Key: 7782233
• Report Number: 3010127658-2018-00001
• Device Sequence Number: 1860923
• Product Code: DXE
• UDI-Device Identifier: B139WV008F0
• UDI-Public: +B139WV008F0/$$71802009/14D201808124
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K172000
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2018

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: Health Professional
• Device Expiration Date: 08/12/2018
• Device Model Number: WV008F
• Device Catalogue Number: WV008F
• Device Lot Number: 1802009
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 08/14/2018
• 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: Life Threatening
• Patient Age: 79 YR