MAUDE Adverse Event Report: ANGIODYNAMICS ANGIOVAC; CATHETER, CANNULA & TUBING, VASCULAR,CARDIOPULMNARY BYPASS

Model Number 25186

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pneumothorax (2012)

Event Date 04/12/2020

Event Type  Injury  

Manufacturer Narrative

This medwatch is not to report a device malfunction, but to report an adverse patient effect.As the reported defective device was not returned, angiodynamics is 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.The reporting facility did not indicate the lot/batch number of the affected product.As a result, a search for similar complaints of the same lot/batch number could not be performed.Labeling review: the angiovac cannula sample was not returned for evaluation since there was no reported device malfunction during the procedure.Directions for use 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.A review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.(b)(4).

Event Description

A clinical specialist reported that a patient came in intubated with known effusion, and unresponsive.An angiovac tee was placed and heart visualized prior to draping.The material was still present upon investigation.Material was massive in appearance on base of tv with mobile pieces as well.Patient was then prepped and draped in a sterile manner.The rfv and lfv access was obtained with micropuncture and ultrasound guidance.Heparin was given and both sites were upsized respectively.Angiovac primed and inserted into rfv and baseline and threshold flows were established in the ivc/ra junction at roughly 2.7/lpm.The physician advanced the angiovac towards the tv to engage the material.After several passes, tee imaging was then interrogated to see if material was still there.Majority of the material on the tv was removed, so physician moved his focus to material on the septal wall.After engaging material there and clearing area, the patient's spo2 fell to 80.Physician decided to sweep the tv again just to see if he could get any additional material.Anesthesiologist began to manage the low spo2.Physician liked the result and decided to end procedure.Blood in circuit was returned to the patient and all equipment was removed.Hemostasis was achieved on the access sites used.During that time spo2 continued to fall.The physician took fluro of lungs and discovered that the patient had a pneumothorax.A chest tube was placed while patient was on table.The patient's pressure began to decline; therefore, pressors were given to elevate pressure.A respiratory therapist was then called in to help manage airway and patient was transferred to the icu.Physician felt while we were debulking the vegetation on the tricuspid valve, septic spores might have dispersed.The patient is septic and may have congestive heart failure which may have contributed to this event.The device used in association with this event is not available for return to the manufacturer.

• Brand Name: ANGIOVAC
• Type of Device: CATHETER, CANNULA & TUBING, VASCULAR,CARDIOPULMNARY BYPASS
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, ma ; 6587805
• MDR Report Key: 10004281
• MDR Text Key: 189591534
• Report Number: 1317056-2020-00076
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: H965251860
• UDI-Public: H965251860
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/28/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: 25186
• Device Catalogue Number: H965251860
• Device Lot Number: 5558296
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2020
• Initial Date FDA Received: 04/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR