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

Catalog Number	WV6203A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Anemia (1706)
Date of Event	01/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient id: (b)(6).It was reported that on (b)(6) 2023 the patient underwent a thrombectomy procedure using the jeti device in the left femoral popliteal bypass graft.During the procedure, the patient lost 300 ml of blood.On (b)(6) 2023 the patient experienced a low hemoglobin/hematocrit (h&h), but no actual source for the bleeding was identified via ct of the abdomen/ pelvis.The patient was transfused with two units packed red blood cells (prbc).Per the physician, there was no device malfunction and the jeti catheter did not cause direct injury to the patient; however, the jeti system works to extract blood, and although the device performed as expected, there may be a causal relationship between the jeti system and the low h&h.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for evaluation.A review of the manufacturing records identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The patient effect of minimal blood loss (anemia) is listed in the all in one peripheral thrombectomy system instructions for use (ifu), as a possible adverse event of use of the device.A conclusive cause for the reported patient effect, and the relationship to the product, if any, cannot be determined.However, the treatments appear to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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: 16453776
• Report Number: 2024168-2023-02045
• Device Sequence Number: 14852831
• Product Code: QEZ
• UDI-Device Identifier: 08717648351396
• UDI-Public: 08717648351396
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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: Study,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/28/2023

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: 08/17/2024
• Device Catalogue Number: WV6203A
• Device Lot Number: 2212026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White