MAUDE Adverse Event Report: ANGIODYNAMICS, INC ANGIOVAC; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	25194
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Pleural Effusion (2010)
Date of Event	11/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported 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).
Event or Problem Description
An angiodynamics territory manager reported a patient adverse event that was discovered immediately following a successful procedure with an angiovac c180 with obturator pg.A post procedure echocardiogram was performed and showed a pericardial effusion.This required the physician to open the patient for repair and to place a drain.The physician believes the pleural effusion may be the result of a wire perforation that occurred during insertion of the wire because the hole in the patient was 'not large;' however, this is not confirmed.Currently, the patient is doing well.The physician has been using angiovac devices for 5 years and is a very experienced user.The procedure was performed in accordance with the directions for use (dfu).
Additional Manufacturer Narrative
The customer's reported complaint description of vessel perforation that caused pericardial effusion cannot be confirmed due to the patient centric nature of this serious adverse event (sae).There were no reports of angiovac device malfunction or performance issue during the procedure, therefore, no angiovac device was returned for evaluation.The root cause of this event is likely an end user error/anticipated procedural complication regarding advancement of guidewire used in the procedure.A device history record (dhr) review of the indicated packaging/assembly/component lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Labeling review: the angiovac cannula sample was not returned for evaluation since there was no reported device malfunction during the procedure.Directions for use (dfu, 16600506-01) is provided with this device and contains the following statements: warnings - selection of the patient as a candidate for use with this device and for such procedures as it is intended is the physicians' sole responsibility.The outcome is dependent on many variables including, patient pathology, surgical procedure, and perfusion procedure/technique.The benefits of use of this device must be weighed against the risks including risks of systemic anticoagulation and must be assessed by the prescribing physician.- 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 initiating and monitoring extracorporeal bypass and by physicians trained and experienced using surgical and/or percutaneous (seldinger) vascular access techniques.Adverse events this device, as do all extracorporeal blood vessel 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 instructions for use are not followed.Possible complications include those normally associated with large bore surgical and/or percutaneous vessel catheterization/cannulation, anticoagulation, extracorporeal circulation and application of intravascular introducer systems which include but are not limited to: - death - damage to vessel - blood loss/blood trauma - hemorrhage - ventricular perforation.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).

• Brand Name: ANGIOVAC
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): ANGIODYNAMICS, INC; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS, INC; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 20906758
• Report Number: 1317056-2024-00253
• Device Sequence Number: 4008534
• Product Code: DWF
• UDI-Device Identifier: H965251940
• UDI-Public: H965251940
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K190594
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2025

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: 12/31/2025
• Device Model Number: 25194
• Device Lot Number: 5813318
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2024
• Supplement Date Received by Manufacturer: 04/24/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 04/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2024
• 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: Life Threatening; Hospitalization; Other; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 30 KG