MAUDE Adverse Event Report: ABBOTT VASCULAR JETI THROMBECTOMY CATHETER SALINE DRIVE UNITS; ASPIRATION THROMBECTOMY CATHETER

Model Number	WVSDUP
Medical Device Problem Codes	Incorrect, Inadequate or Imprecise Result or Readings (1535); Suction Problem (2170); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that during demonstration use during a conference, the jeti saline drive unit (sdu) was used.During demo use, the demo thrombus was pushed away, rather than being aspirated.This was a new occurrence, not having happened during patient use, and there was no patient involvement, as this was demo use.A few days later, the jeti sdu was tested, and the aspiration numbers stayed in the low 20's rather than 26-30 as expected.It was believed that there was an issue with the sdu and replacement was requested.There was no patient involvement with either of these events.No additional information was provided.
Event or Problem Description
Subsequent to the initial report, additional information was provided.During the conference, the jeti sdu was used with previously used, but in good condition, demonstration catheter / components.The demo thrombus "flarp" was placed in water and was in good condition.The system had been primed prior to use and the suction cannister had room to allow for more suction.No alarms were displayed on the sdu screen.Additionally, during the testing a few days later, the aspiration numbers stayed in the low -20's, rather than -26 to -30 as expected.There were no alarms displayed and information provided in the instructions for use does not state the range the device should display for negative pressure.Although the sdu was not a demo device, the components used were and do not function the same as actual thrombus in the patient anatomy.This additional information would not be reportable; however, this event has been reported.Therefore, the event will remain reportable.No additional information was provided.
Additional Manufacturer Narrative
Analysis will not be required as additional information was received indicating there was no device malfunction or adverse event associated with this device.H6; medical device problem code 2170 and 1535 - removed.

• Brand Name: JETI THROMBECTOMY CATHETER SALINE DRIVE UNITS
• Common Device Name: ASPIRATION THROMBECTOMY CATHETER
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15882909
• Report Number: 2024168-2022-12006
• Device Sequence Number: 5103274
• Product Code: QEZ
• UDI-Device Identifier: 08717648351365
• UDI-Public: 08717648351365
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/07/2025
• Device Model Number: WVSDUP
• Device Catalogue Number: WALK03WVSDUP
• Device Lot Number: 210903204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2022
• Supplement Date Received by Manufacturer: 01/10/2023
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 01/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2021
• 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
• Patient Sex: Unknown