MAUDE Adverse Event Report: ABBOTT VASCULAR JETI PERIPHERAL THROMBECTOMY CATHETERS; ASPIRATION THROMBECTOMY CATHETER

Catalog Number	WV8803A
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2024
Type of Reportable Event	Malfunction
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.Additionally, a review of the complaint history identified no similar incidents from this lot.It is unknown if jeti catheter interacted with the previously implanted stent; therefore, a conclusive cause could not be determined.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 procedure was to treat an occluded aortic graft in the iliac artery.The 8fr jeti hydrodynamic thrombectomy catheter passed through the occluded segment two times.Angiography showed the left limb was patent.Balloon angioplasty was performed in two areas of residual stenosis.An angled catheter passed through the aorta to perform the final angiography runs when it was noted the implanted stent had migrated from the left common iliac and was free floating in the aorta.Per the physician, it is unknown if the jeti catheter or the angled catheter caused the stent to dislodge and migrate.No additional information was provided.

• Brand Name: JETI PERIPHERAL THROMBECTOMY CATHETERS
• 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: 19052419
• Report Number: 2024168-2024-04342
• Device Sequence Number: 8188111
• Product Code: QEZ
• UDI-Device Identifier: 08717648351402
• UDI-Public: (01)08717648351402(17)250308(10)3092861
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/05/2024

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: 03/08/2025
• Device Catalogue Number: WV8803A
• Device Lot Number: 3092861
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 04/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Sex: Unknown