MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / ANGIOVAC; CATHETER, CANNULA & TUBING, CARDIOPULMONARY

Model Number	25184
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	01/19/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation into this event is on-going.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported by angiodynamics' clinical specialist: ""angiovac was advanced to lt pa - thrombus removed, cannula pulled back and lost access to pa (in rv).Wire manipulated to rt.Pa and cannula readvanced from rv to left pa.Pressures began to drop but were medically managed.O2 sats were at 100%.Cannula and wire were removed.Ivc filter placed from rt.Groin.Both rt.Femoral vein and rt.Ij lines were pulled and pressured was held.The patient's blood pressure began to drop.Heart rate became non-existant and cpr was started.After several rounds of epi and bicarb patient was declared in aystole.Since the tee probe was still in place anesthesia took a look at the heart and saw effusion surrounding it.The doctor put a long needle into the chest and removed a syringe of blood confirming cardiac tampenade.He then prepped and performed a stenotemy which resulted in the release of fluid from around the heart and the immediate return of normal sinus rhythm and aystole heart rate.Upon evacuation of the blood, a hole was found in the apex of the right ventricle which was repaired with a surgical stitch.Once patient was deemed stable her chest was closed and she was sent to the cvor unit."case completed successfully.It was indicated that the reported device is not available to be returned to the manufacturer for evaluation.

• Brand Name: ANGIODYNAMICS / ANGIOVAC
• Common Device Name: CATHETER, CANNULA & TUBING, CARDIOPULMONARY
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801, ny
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801, ny
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, ma ; 6587805
• MDR Report Key: 5768875
• Report Number: 2952363-2016-00002
• Device Sequence Number: 3155976
• Product Code: DWF
• UDI-Device Identifier: H965251840
• UDI-Public: H965251840
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K091304
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/10/2020

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: 08/31/2016
• Device Model Number: 25184
• Device Catalogue Number: VTX-3022
• Device Lot Number: 108763
• 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: 01/19/2016
• Supplement Date Received by Manufacturer: 01/19/2016
• Initial Report FDA Received Date: 07/05/2016
• Supplement Report FDA Received Date: 07/05/2016
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2015
• 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: Life Threatening; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female