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

Catalog Number	WV8803A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	01/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The patient effect of peroration is listed in the jeti hydrodynamic thrombectomy system instructions for use (ifu), potential adverse events section as a potential adverse event.The reported patient effect of perforation is a known inherent risk of the procedure.Based on the information reviewed, there is no indication a product quality issue with respect to manufacture, design or labeling.
Event or Problem Description
It was reported the jeti hydrodynamic thrombectomy system was used in the right femoral vein.After removing the jeti catheter, an image was taken through the sheath with contrast when a perforation was noted in the patient¿s right popliteal vein.The physician pulled the sheath and held manual pressure to complete the procedure.There were no adverse patient sequela and no clinically significant delay in the procedure.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: 18708012
• Report Number: 2024168-2024-01837
• Device Sequence Number: 12538415
• Product Code: QEZ
• UDI-Device Identifier: 08717648351402
• UDI-Public: 08717648351402
• 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
• Report Date (Section B): 02/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/24/2025
• Device Catalogue Number: WV8803A
• Device Lot Number: 3092862
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown