ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATION F18 85

Report

Report Number: 1319211-2025-00041
Event Type: Death
Date Received: October 16, 2025
Date of Event: September 16, 2025
Report Date: November 25, 2025
Manufacturer: ANGIODYNAMICS, INC.
Product Code: QEZ
UDI-DI: H787253020
PMA / PMN Number: K240397
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: PHYSICIAN
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF PATIENT EMBOLIZATION AND SUBSEQUENT EXPIRATION CANNOT BE CONFIRMED GIVEN THE PATIENT CENTRIC NATURE OF THIS SERIOUS ADVERSE EVENT (SAE). THERE WERE NO REPORTS OF ALPHAVAC DEVICE MALFUNCTION DURING THE PROCEDURE; THEREFORE, THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE PHYSICIAN STATED THAT THE PATIENT'S EXPIRATION IS IN NO WAY ASSOCIATED WITH THE ALPHAVAC DEVICE BUT DUE TO PATIENT COMORBIDITIES. A DEVICE HISTORY RECORD (DHR( REVIEW OF THE PACKAGING/CANNULA ASSEMBLY LOTS REVEALED NO QUALITY RELATED ISSUES OR MANUFACTURING DEFICIENCIES AT THE TIME OF MANUFACTURE. LABELING REVIEW: THE DIRECTIONS FOR USE (DFU) THAT IS PROVIDED WITH THIS DEVICE CONTAINS THE FOLLOWING STATEMENTS: INDICATIONS FOR USE: THE CANNULA IS INDICATED FOR: THE NON-SURGICAL REMOVAL OF THROMBI OR EMBOLI FROM THE VENOUS VASCULATURE. ASPIRATION OF CONTRAST MEDIA AND OTHER FLUIDS FROM THE VENOUS VASCULATURE. THE CANNULA IS INTENDED FOR USE IN THE VENOUS SYSTEM AND FOR THE TREATMENT OF PULMONARY EMBOLISM. DIRECTIONS FOR USE AND MANUALS FOR THE ALPHAVAC SYSTEM AND ALL RELATED ACCESSORIES SHOULD BE READ PRIOR TO USE AND DEVICES USED AS INDICATED. AS WITH ALL MEDICAL DEVICES, THIS DEVICE AND ANCILLARY EQUIPMENT ARE TO BE USED BY TRAINED PHYSICIANS ONLY. SPECIFICALLY, THIS DEVICE IS TO BE USED ONLY BY MEDICAL PERSONNEL EXPERIENCED WITH USING SURGICAL AND/OR PERCUTANEOUS (SELDINGER) VASCULAR ACCESS TECHNIQUES AS WELL AS PHYSICIANS TRAINED AND EXPERIENCED IN PERCUTANEOUS, INTRAVASCULAR, DIAGNOSTIC AND INTERVENTIONAL TECHNIQUES REQUIRING FLUOROSCOPIC OR IMAGE GUIDANCE AND VISUALIZATION. 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: DISTAL EMBOLIZATION OF THROMBUS, PULMONARY EMBOLISM, CARDIAC ARREST, DEATH. A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT CONTINUES TO BE MONITORED FOR TRENDS. REFERENCE: (B)(4).

Additional Manufacturer Narrative · 0

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 · 0

AN ANGIODYNAMICS SENIOR TERRITORY MANAGER REPORTED RECEIVING NOTIFICATION FROM A PHYSICIAN, THAT THE FOLLOWING EVENT OCCURRED DURING AN ALPHAVAC PULMONARY EMBOLISM PROCEDURE: " I WAS CONTACTED BY (B)(6) TO SEE IF I COULD COVER A PE CASE. IT WAS A 2.5 HOUR DRIVE SO THE HOSPITAL WAS PREPARING TO START THE CASE KNOWING I WOULD ARRIVE AT ROUGHLY 2PM. THE PHYSICIANS, DR. (B)(6), WERE SCRUBBED IN WHEN I ARRIVED. THEY HAD A PIGTAIL CATHETER IN THE PATIENTS PA. THE PATIENT WAS INTUBATED BUT I DID NOT GET ANY ADDITIONAL INFORMATION AS TO WHAT LEAD TO HER INTUBATION OR HOW SHE PRESENTED WITH HER PE. I DID NOT GET HER EXACT DOB BUT THE STAFF SAID SHE WAS IN HER LATE 70'S AND THE PHYSICIAN SAID THAT SHE "HAD MANY MEDICAL PROBLEMS IN ADDITION TO HER PE". THE PHYSICIANS DID NOT HAVE ANY TROUBLE USING ALPHAVAC. THEY WERE ABLE TO DELIVER THE OVER SHEATH AND MANIPULATE THE CANNULA WITHOUT TROUBLE IN THE RIGHT LUNG AND IN THE LEFT LUNG. WHILE IN THE LEFT LUNG DR. (B)(6) NOTICED THE CANNULA WAS KINKED ON THE MOST PROXIMAL END NEAR THE HANDLE FROM HOLDING THE HANDLE AT AN ANGLE THAT CAUSED THE KINK. THEY REMOVED THE CATHETER, DELIVERED A PIGTAIL TO THE MAIN PA AND TOOK AN ANGIO. THEY NOTICED THAT THERE WAS STILL CLOT IN THE RIGHT LOWER LOBE SO THEY OPENED A NEW CATHETER AND DELIVERED IT WITHOUT TROUBLE INTO THE RIGHT LOWER LOBE AND REMOVED ADDITIONAL CLOT. AFTER THE LAST ASPIRATION THE PATIENT'S BLOOD PRESSURE SLIGHTLY IMPROVED BUT THE PATIENT WAS STILL VERY SICK. BOTH PHYSICIANS FELT THE CASE WAS TECHNICALLY A SUCCESS AND THAT THEY REMOVED A LARGE AMOUNT OF ORGANIZED CLOT FROM THE RIGHT AND LEFT LUNGS. AT SOME POINT NEAR THE END OF THE CASE THEY GAVE THE PATIENT 4 UNITS OF BLOOD DUE TO HER HEMOGLOBIN BEING LOW AT THE BEGINNING OF THE CASE AND WHEN THEY RECHECKED IT WAS LOWER THAN WHEN THEY STARTED THE CASE. BOTH PHYSICIANS SCRUBBED OUT AND THE ANESTHESIA STAFF AND TECHS/NURSES WERE TENDING TO THE PATIENT TO PREPARE TO SEND HER TO THE ICU FOR RECOVERY. THEY CLOSED HER ACCESS AT APPROXIMATELY 3PM. DR. (B)(6) AND I WERE DISCUSSING THE ALPHAVAC AND FUTURE OPPORTUNITIES FOR TRAINING AND EDUCATION WHEN A STAFF MEMBER CAME TO GET DR. (B)(6) TO LET HIM KNOW THEY WERE STARTING CHEST COMPRESSIONS. UNFORTUNATELY, THE PATIENT PASSED AWAY. DR. (B)(6) REASSURED ME THAT HE DIDN'T FEEL THAT ANYTHING WENT WRONG DURING THE THROMBECTOMY BUT THAT THE PATIENT WAS TOO SICK FROM THE PE AND OTHER MEDICAL ISSUES AND THAT THEY DID EVERYTHING THEY COULD TO SAVE HER LIFE."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2393159	ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATION F18 85	ASPIRATION THROMBECTOMY CATHETER	QEZ	ANGIODYNAMICS, INC.	25-302		H787253020

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Female	Death	ALPHAVAC MULTIPURPOSE MECHANICAL ASPIRATOR F18 C8.