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

Model Number	WV062F
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The jeti all in one thrombectomy system operated as intended with no device malfunction observed.The treatment of the patient's limb ischemia was determined to be successful.The device was not returned for evaluation and discarded after the procedure.A review of the lot history records identified no observations related to this event.The lot involved no related nonconformities and met all product 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 1 angioplasty balloon inflation in addition to thrombectomy.There is no indication of any product issues in respects to the design, manufacture, or labeling of the device.
Event or Problem Description
After a successful thrombectomy procedure in the lower left and right extremities, the hemoglobin dropped from 9 to 7 g/dl after the procedure and the physician ordered a blood transfusion.
Event or Problem Description
Subsequent to the initial medwatch report, the following information was reported.The blood transfusion given to the patient prolonged the hospitalization.No addtional information was received.

• 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 daimler street; irvine CA 92614
• Manufacturer Contact: shawn kelly ; 17171 daimler st; irvine, CA 92614 ; 9495856512
• MDR Report Key: 15481531
• Report Number: 3010127658-2022-00002
• Device Sequence Number: 12448675
• Product Code: QEZ
• UDI-Device Identifier: B139WV062F0
• UDI-Public: +B139WV062F0/$$72110041/14D20231029X
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K213565
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/22/2022

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 Expiration Date: 10/29/2023
• Device Model Number: WV062F
• Device Lot Number: 2110041
• 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: 08/25/2022
• Supplement Date Received by Manufacturer: 08/25/2022
• Initial Report FDA Received Date: 09/24/2022
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/29/2021
• 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: BALLOON ANGIOPLASTY; LYTIC (ACTIVASE); LYTIC (TPA)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 59 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White