MAUDE Adverse Event Report: ABBOTT VASCULAR JETI ALL IN ONE KIT; ASPIRATION THROMBECTOMY CATHETER

Catalog Number	WV8803A
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that the procedure was performed using the jeti thrombectomy system.The jeti sterile disposable kit was opened; however, it was noted that although the outer package had an expiration date of 08/16/2024, one component had an expiration date of 04/20/2023.The two additional components had an expiration date of 08/16/2023.The expiration dates were noted prior to opening the individual component packaging or using the devices.The device components were not used and there was no patient involvement.The procedure was continued and successfully completed with a second jeti kit.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The expiration date error was confirmed.A review of the manufacturing records identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history of the reported lot did not indicate a lot specific quality issue.The investigation could not determine the cause of the reported issue as the j-set lot number was not in inventory when the kit was assembled as it was fully exhausted 17 months prior.In this case, it is possible, the kit was mixed in the field by a tech/rep; however, this cannot be confirmed.There is no indication of a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
Returned device analysis of the jeti disposable kit revealed that the outer package of the jeti sterile disposable kit had an expiration date of 08/16/2024; however, one component, the pump set (j-set), had an expiration date of 04/20/2023.The two additional components, had the following expiration dates: suction tubing (wvhand) had an expiration date of 9/14/2024 and the catheter (wv088f) had an expiration of 08/16/2024.No additional information was provided.

• Brand Name: JETI ALL IN ONE KIT
• 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: 17398384
• Report Number: 2024168-2023-08059
• Device Sequence Number: 15367977
• Product Code: QEZ
• UDI-Device Identifier: 08717648351402
• UDI-Public: 08717648351402
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 10/05/2023

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: 08/16/2024
• Device Catalogue Number: WV8803A
• Device Lot Number: 2212049
• 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: 07/05/2023
• Supplement Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 10/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2022
• 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