MAUDE Adverse Event Report: ANGIODYNAMICS ALPHAVAC; ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATOR

Model Number	25-302
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	09/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Event or Problem Description
This medwatch is not to report a device malfunction, but to report an adverse patient effect during a procedure in which angiodynamics' product was used.An angiodynamics clinical services manager reported a patient issue, during treatment with an alphavac multipurpose mechanical aspirator f18 c85.The following was reported: "23 female with bilateral pulmonary embolisms.Described by physician as very sick and with co-morbidities including obesity and enlarged heart.Intubated for procedure under general anesthesia.Wire and catheter advanced to pa from rfv access site.Pa pressure measurement of 39mmhg obtained.Pulmonary arteriogram of rpa obtained that demonstrated distal material at the segmental bifurcation.Gore 22fr access to rfv.F1885 alpha chosen.Glide wire to rpa, exchanged for amplatz ss 1cm floppy tip.1st attempt to advance alpha sheath unsuccessful.Cardiac silhouette greater than half the chest width.Angle from tv to rvot is challenging / severe.Wire re-advanced to rpa and sheath able to be advanced on second attempt.Tip of sheath parked in distal rpa near the segmental bifurcation.Cannula flushed and advanced to tip of sheath, sheath then pulled back to expose funnel.10ml pulls partially filled barrel.Cannula pulled back slightly and 10ml pull shows no blood in barrel.Physicians believe the funnel to be on clot.They switch to 30ml pull and barrel remains empty.The vacuum lock button is used and 2 minute wait is started.After 2 minutes approx 5ml of blood present in barrel.Cannula then pulled back to reposition with immediate blood return.Cannula slips back to bifurcation of pa.Attempt to re-advance to rpa unsuccessful.Cannula rotated to face the lpa and cannula advanced into lpa.One 30ml pull performed with no blood return.Anesthesia reports dropping etco2, then dropping blood pressure.Alphavac cannula retrieved into oversleeve / sheath and sheath removed from pa and pulled back into gore sheath.Cpr initiated for no pulse and no etco2.Pulse returned after cpr.Procedure discontinued.Patient transported back to unit.No device failure observed or reported by physician.".
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The product was not returned for evaluation since there was no report of alphavac malfunction during the procedure.The customer's reported complaint description cannot be confirmed due to the patient centric nature of this cardiac serious adverse event (sae).There were no reports of alphavac device malfunction during the procedure, therefore, no device was returned for evaluation.A review of the device history record was performed for the indicated packaging lot for any deviations related to the distribution of this device.The review confirms that their was no distribution related non-conformance/ncr.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 pr(b)(4).

• Brand Name: ALPHAVAC
• Common Device Name: ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATOR
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 15638255
• Report Number: 1319211-2022-00043
• Device Sequence Number: 17771862
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2022

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: 07/31/2021
• Device Model Number: 25-302
• Device Catalogue Number: 25302
• Device Lot Number: 5731113D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/10/2022
• 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: Other; Required Intervention
• Patient Age: 23 YR
• Patient Sex: Female