MAUDE Adverse Event Report: WALK VASCULAR, LLC JETI ALL IN ONE THROMBECTOMY SYSTEM; EMBOLECTOMY CATHETER

Model Number	WV088F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Fever (1858); Low Blood Pressure/ Hypotension (1914); Tics/Tremor (4425)
Date of Event	07/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
After a successful thrombectomy procedure in the lower left extremity, the subject developed an acute onset of hypotension, tremors, and fever requiring treatment and prolonged hospitalization.The patient was treated with medication and the adverse event was resolved the next day ((b)(6) 2022).
Additional Manufacturer Narrative
The jeti thrombectomy system operated as intended with no device malfunction observed.The treatment of the patient's deep vein thrombosis was determined to be successful achieving vascular patency in the lower left extremity.The device was not returned for evaluation and discarded after the procedure.A review of the lot history record identified no observations related to this event.The lot involved no related nonconformities and met all product requirements including sterilization and endotoxin limit requirements.Additionally, a review of the complaint and reportable event history identified no other similar incidents.The investigation was unable to determine a conclusive cause for the adverse event though could have been potentially related to patient conditions or the procedure, which also included stent placement and 7 angioplasty balloon inflations in addition to thrombectomy.The device is aspiration based and blood loss could have been a potential factor for hypotension, however only 75 ml of blood/thrombus mixture was aspirated from the patient and 73 ml of contrast agent was delivered into the patient which makes blood loss an unlikely factor.There is no indication of any product issues in respects to the design, manufacture, or labeling of the device.

• Brand Name: JETI ALL IN ONE THROMBECTOMY SYSTEM
• Common Device Name: EMBOLECTOMY CATHETER
• Manufacturer (Section D): WALK VASCULAR, LLC; 17171 daimler street; irvine CA 92614
• Manufacturer (Section G): WALK VASCULAR, LLC; 17171 damiler street; irvine CA 92614
• Manufacturer Contact: shawn kelly ; 17171 damiler street; irvine, CA 92614 ; 9495856512
• MDR Report Key: 15299549
• Report Number: 3010127658-2022-00001
• Device Sequence Number: 7307221
• Product Code: QEZ
• UDI-Device Identifier: B139WV088F0
• UDI-Public: +B139WV088F0/$$722201037/14D202401183
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K201998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/25/2022

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 Model Number: WV088F
• Device Catalogue Number: WV088F
• Device Lot Number: 2201037
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 08/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2022
• 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: 8 FR GUIDING SHEATH; BALLOON ANGIOPLASTY, 3 INFLATIONS; BALLOON ANGIOPLASTY, 4 INFLATIONS; STENT
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 120 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White