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

Model Number	25194
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Exsanguination (1841)
Date of Event	12/30/2020
Type of Reportable Event	Death
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.This medwatch is not to report a device malfunction, but to report an adverse patient effect post procedure.There was no report of a device malfunction or patient complication during the procedure.Reference (b)(4).
Event or Problem Description
An angiodynamics senior tm reported an event during a case where an angiovac device was used to assist in tricuspid vegetation removal with lead extraction.The tm was attending the procedure.Per her event description: today we did our first angiovac case using the new c180 cannula.The patient was a male who was pacemaker dependent, had diabetes, foot ulcers, had kidney failure requiring dialysis, and a very poor lv ejection fraction of only 12%.The patient had four leads that needed to be laser extracted and vegetation was noted on two areas of the tricuspid valve.The surgeon's plan was to use angiovac to remove the vegetation from the tricuspid valve (which it did very well) and then keep the angiovac in the ra while the laser lead extraction was occurring to suction up any debris that escaped from the leads while being extracted.During the lead extraction, the patient's pressure and heart rate started to decline.There was blood loss associated with the lead extraction and the patient was quite ill as noted above to start with.Despite efforts to increase both the patient's pressure and heart rate, he subsequently succumbed during the procedure.This is not a product complaint against angiovac.The operator said in his report that the angiovac did its job and did it well.The reported device is not available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
(b)(4).No product was returned for evaluation since there was no report of angiovac device malfunction during the procedure.As the device was not returned, angio-dynamics was unable to perform a device evaluation.The customer's reported complaint description cannot be confirmed due to the nature of this patient adverse event; there were no reports of angiovac device malfunction during the procedure.No correction is required since there was no reported device malfunction during the procedure, i.E.Device functioned as intended and did not directly contribute to patient adverse event/expiration.Cardiac complications/pe are potential anticipated procedural complication of an angiovac procedure; this is cautioned in the dfu.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, 14600506-01) 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.Pulmonary embolism (pe).Arrhythmias.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 (b)(4).

• 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 12801
• MDR Report Key: 11182949
• Report Number: 1317056-2021-00010
• Device Sequence Number: 14401615
• Product Code: DWF
• UDI-Device Identifier: H965251940
• UDI-Public: H965251940
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K142593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2021

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 Model Number: 25194
• Device Catalogue Number: 25194
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/30/2020
• Supplement Date Received by Manufacturer: 12/30/2020
• Initial Report FDA Received Date: 01/17/2021
• Supplement Report FDA Received Date: 01/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death