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

Model Number	WVSDUP
Medical Device Problem Codes	Decrease in Pressure (1490); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2022
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 the jeti saline drive unit (sdu) was not functioning properly as the highest negative pressure was 25.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.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.B3 - date of event updated h6 - medical device problem code 1490 removed.
Event or Problem Description
Subsequent to the initially filed medwatch report, additional information was received.It was reported that the jeti was used to treat a clot.The procedure was completed using the jeti sdu and a ekos catheter.There was no clinically significant delay in the procedure and no adverse patient effects.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.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.D9- device available for evaluation updated from ¿no¿ to ¿yes¿ h6- type of investigation code 4114 was removed and code 10 testing of actual/suspected device was added.

• 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 (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15924184
• Report Number: 2024168-2022-12244
• Device Sequence Number: 17457568
• Product Code: QEZ
• UDI-Device Identifier: 08717648351365
• UDI-Public: 08717648351365
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 05/22/2023

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 Model Number: WVSDUP
• Device Catalogue Number: P03903WVSDUP
• Device Lot Number: 220806402
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/12/2022
• Supplement Date Received by Manufacturer: 12/13/2022; 05/02/2023
• Initial Report FDA Received Date: 12/06/2022
• Supplement Report FDA Received Date: 01/06/2023; 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2022
• 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
• Patient Sex: Unknown