ALPHAVAC
Received Jul 10, 2026 · Event occurred Jun 10, 2026
Report 1319211-2026-00227 · MDR key 25782174
Device
Generic name
Aspiration Thrombectomy Catheter
Manufacturer
Angiodynamics, Inc.Model number
H787253020Catalog number
25-302
Lot number
5861925
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
55 YR · Male
- Embolism/Embolus
Narrative
Additional Manufacturer Narrative
THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE FOR THE EVENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. REFERENCE (B)(4).
Description of Event or Problem
AN ANGIODYNAMICS REGIONAL BUSINESS MANAGER REPORTED A PATIENT EXPIRED DURING USE OF AN ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATOR F18 C85. IT WAS REPORTED THAT THE PATIENT EXPIRED DURING A PULMONARY EMBOLISM THROMBECTOMY PROCEDURE. THE PHYSICIAN BELIEVES THAT THE PATIENT'S EXPIRATION IS DUE TO A SUSPECTED CORONARY EMBOLISM. PRESSERS WERE ADMINISTERED AND CPR WAS PERFORMED, BUT ATTEMPTS TO REVIVE THE PATIENT WERE UNSUCCESSFUL. AT THIS TIME, ADDITIONAL GOOD FAITH EFFORT IS BEING PERFORMED TO OBTAIN FURTHER DETAILS.