MAUDE Adverse Event Report: ANGIODYNAMICS ALPHAVAC; ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATION 25F/C20

Model Number	25-302
Medical Device Problem Codes	Material Twisted/Bent (2981); Device Handling Problem (3265)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up.Reference (b)(4).
Event or Problem Description
An end user experienced an issue when using an alphavac multipurpose mechanical aspirator f18 c8.During the procedure, the cannula kinked to an unusable state trying to advance thru the hemostatic valve on the sheath.After removing the funnel from the valve, it would not hold hemostasis anymore and blood began to leak from the pulmonary arteries at a high amount from the patient.The amount of blood loss was estimated to be approximately 30-40cc's.No medical treatment was provided to address the blood loss.The procedure was completed with a second alphavac f18.It was reported the patient was discharged the following day.
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of "cannula kinked" and after removal of the cannula through the hemostasis valve, bleed back occurred through the valve, could not be confirmed - sample was not received.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.Based on event description the potential root cause of the bleed back is damage to the hemostasis valve during removal of the severely kinked cannula through the sheath hub/valve.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.  the review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: directions for use is provided with this device and contains the following statements: adverse events: this device, as do all embolectomy systems and devices, has possible side effects, which include, but are not limited to infections, blood loss, thrombus formation, embolic events, vessel, ventricular or valvular damage and complications of percutaneous or surgical insertion techniques.These may occur if the directions for use are not followed.Possible complications include those normally associated with large bore surgical and/or percutaneous vessel catheterization/cannulation, anticoagulation, and application of intravascular introducer systems which include but are not limited to: death, distal embolization of thrombus, pulmonary embolism.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).
Additional Manufacturer Narrative
After further review of the reported complaint, there was no patient harm, adverse event, or medical intervention required as a result of the device having a missing component.Therefore, angiodynamics has reassessed the regulatory reporting of this event based on reportability criteria and concluded that this event does not meet reporting requirements.Please disregard the initial report that was inadvertently sent and accept this as a final close out report of this event not meeting regulatory reporting.Reference (b)(4).

• Brand Name: ALPHAVAC
• Common Device Name: ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATION 25F/C20
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 16311880
• Report Number: 1319211-2023-00006
• Device Sequence Number: 6803266
• Product Code: QEZ
• UDI-Device Identifier: H787253020
• UDI-Public: H787253020
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K211081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/03/2024

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: 10/31/2024
• Device Model Number: 25-302
• Device Catalogue Number: 25302
• Device Lot Number: 5755579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2023
• Supplement Date Received by Manufacturer: 05/08/2023; 07/03/2024
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 05/10/2023; 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2022
• 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 Age: 55 YR
• Patient Sex: Female