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

Model Number	WV6203A
Medical Device Problem Codes	Increase in Pressure (1491); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the jeti aspiration device was unable to be prepped.After priming the system, it would not advance to the next step and an error occurred.A high pressure alert.There was no damage noted to the catheter and all connections to the pump were tightly set.No kinks in the tubing were noted.The device was not used and there was no patient involvement.There was no clinically significant delay.After the case.The saline drive unit (sdu) and pump set were tested with a demo catheter and the sdu and pump set worked appropriately.Returned device.Analysis noted device contamination appearing to be filter material, plugging the saline orifice.No additional information was provided.
Additional Manufacturer Narrative
The device was returned for analysis.The reported high pressure alert was confirmed.Additional investigation was performed and noted what appeared to be filter material plugging the saline orifice.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 similar incidents from this lot.The analysis of the device identified contamination that was plugging the saline orifice and was concluded to be related to a potential product quality issue.Walk vascular non-conforming material report (ncmr) was initiated due to the potential product quality issue and corrective action.If any, will be determined per walk vascular operating procedure.

• 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): WALK VASCULAR #3010127658; 17171 daimler st; irvine CA 92614
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16728253
• Report Number: 2024168-2023-03751
• Device Sequence Number: 6673886
• Product Code: QEZ
• UDI-Device Identifier: 08717648351396
• UDI-Public: 08717648351396
• 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
• Report Date (Section B): 04/12/2023

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: 04/28/2024
• Device Model Number: WV6203A
• Device Catalogue Number: WV6203A
• Device Lot Number: 2209003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 04/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2022
• 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