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

Model Number 25186

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/25/2020

Event Type  malfunction  

Manufacturer Narrative

Returned for evaluation was one used angiovac.As received, the device was contaminated with bio matter {blood} inside and outside.The outer balloon (membrane) was intact (bonded) to all four petals.The inner balloon contained what appeared to be dried contrast material inside.No visual tears were noted to the balloon.Cannula was kinked in two {2} places.During functional testing, the balloon was unable to be inflated due to the occluded inflation line.The customer's complaint for "balloon torn" could not be confirmed due to the condition the sample was received in; inflation line occluded.When air pressure tested, the inner balloon did not inflate due to an occlusion in the inflation line.Based on event description the end user inflated the balloon up to but less than 2 atms.Per dfu, the inner balloon is to be inflated no greater than 1 atm.The condition of the returned sample with dried contrast in the inflation lumen and inner balloon is as expected as balloon is inflated with saline/contrast mixture during procedure.The dried contrast does prevent confirmation of balloon inflation performance and if a tear/burst in the inner balloon is present.It was confirmed that the outer membrane was intact.A definitive rootcause for the event cannot be established.However, a potential root cause of this event is end user inflated the inner balloon greater than 1 atm which resulted in inner balloon burst/tear.This would leak the saline/contrast mixture into the outer membrane and not into the patient's vasculature.The burst/tear of the inner balloon would affect the ability of the cannula pedals to open properly.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.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, 16600502-01) 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, damage to vessel.Operational instructions: avoid over inflation of the balloon and over expansion of the cannula tip greater that the diameter of the target vessel as damage to the vessel wall may occur.Attach endoflator to the inflation port.Open the stopcock to air and pull negative pressure to remove any residual air in the inflation lumen or balloon.Close the stopcock to air.Detach endoflator and fill with 30% contrast/saline mixture.Attach endoflator to the inflation port.Open the stopcock at the inflation port and inflate the distal balloon to no greater than 1 atm.Caution: do not over inflate the balloon.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).

Event Description

An angiodynamics territory manager reported that during a patient's procedure using the angiovac 20 degree cannula, the physician inflated the funnel (balloon) to <2 atmospheres, and the funnel (balloon) appeared to have torn while inside the patient.(over inflation of balloon, causing it to burst/tear).None of the balloon fragmented off during the deflation.The device was withdrawn and set aside and a new cannula was used to complete the procedure.There was no harm or injury to the patient due to this event.The reported device has been returned to the manufacturer and an investigation into the root cause for event is currently in progress.

• Brand Name: ANGIODYNAMICS / ANGIOVAC
• Type of Device: CATHETER, CANNULA & TUBING, CARDIOPULMONARY
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 10706801
• MDR Text Key: 212331957
• Report Number: 1317056-2020-00164
• 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: 10/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 25186
• Device Catalogue Number: 25186
• Device Lot Number: 5542202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/25/2020
• Initial Date FDA Received: 10/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2019
• 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 Age: 41 YR