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

Model Number	WVSDUP
Medical Device Problem Codes	Loose or Intermittent Connection (1371); Electrostatic Discharge (2149); Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the patient underwent a procedure, to remove thrombus from the popliteal to left femoral vein.The jeti aspiration saline drive unit (sdu) was used.Initially, the sdu was working appropriately; however, during use, the sdu turned off.It was noted that the power cord that plugs into the sdu connection was loose.It was pushed back in, the system was turned back on, and the device worked appropriately during the rest of the procedure.There was no adverse patient effect or clinically significant delay.After the procedure, troubleshooting was performed on the sdu.The sdu was plugged in and turned on.The power cord was loosed and was pushed in; the device began to spark.The device was not being used in a procedure at this time, so there was no patient effect.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported loose connection, power problem and sparking were confirmed.A review of the manufacturing records revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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): WALK VASCULAR #3010127658; 17171 daimler st; irvine CA 92614
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16287903
• Report Number: 2024168-2023-01120
• Device Sequence Number: 6852294
• Product Code: QEZ
• UDI-Device Identifier: 08717648351365
• UDI-Public: 08717648351365
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 05/10/2023

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: WVSDUP
• Device Lot Number: 220602001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 02/02/2023
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/18/2022
• 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
• Patient Age: 82 YR
• Patient Sex: Female