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

Model Number 25186

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Decreased Respiratory Rate (2485)

Event Date 04/27/2021

Event Type  malfunction  

Manufacturer Narrative

The reported defective device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the device evaluation will be sent via a follow up medwatch.Reference (b)(4).

Event Description

An angiodynamics senior clinical science liason reported an issue with an angiovac cannula with dilator (20 degree angle).The following was reported: (b)(6) year old male, who received the moderna covid-19 vaccine on (b)(6) 2021.Patient presented to the er with swelling in his left leg that started 3 days prior.Cta of the chest showed extensive bilateral pulmonary emboli in the distal main pulmonary arteries extending into the sub-segmental branches.Ct of the abdomen and pelvis showed extensive venous thrombosis, involving the ivc, left common iliac vein, and left femoral vein.The gen 2.Angiovac cannula balloon was prepped utilizing the "double negative" method, to insure the air had been removed from the balloon.The cannula was inserted from the rij and positioned at the svc/ra junction.The balloon was inflated to 1.5 atm.And flow was established at 2.2 l/min.Initially under fluoro, the balloon fully expanded and funnel petals were opposed, but not fully opened.The balloon was deflated, a "double negative" was performed a second time, then the balloon was reinflated.The cannula funnel showed the "petals" to be open, but not fully opposed.Floe rates were good, so the physician advanced the cannula into the proximal ivc.As soon as the cannula was advanced, the petals shut down.The cannula was pulled back, flow was stopped and the petals appeared to reopen.Flow was reestablished and the cannula was again, advanced into the ivc.The petals again collapsed and flow was lost.A hand injected venogram was performed, to identify any possible material/obstruction, which could cause the funnel to collapse.No material was visualized in the area, where the funnel was collapsing.It appeared to me, that the balloon may have been deflating slightly.The cannula was removed and the funnel was inflated in a basin of water to check for any possible leaks/punctures to the balloon.No were seen.At this time the patient started to become unstable and oxygen saturations began to drop.The anesthesiologist was concerned that the patient may not do well if the procedure continued, due to his pe's.The cannula was reinserted, flows reestablished at 1.7 l/min and four passes, were made down the proximal ivc.The cannula funnel was clearly not completely open, and no material was extracted.The physician decided to end the procedure.The patient was stable post procedure, but their oxygen saturation had dropped to 93%.The procedure was aborted due to the unstableness of the patient and the failure of the funnel to remain open.No other device was utilized, at that time.The pe was being treated with heparin and lytics were going to be started post angiovac it was indicated the reported device is available for return to the manufaturer for a device evaluation.

Manufacturer Narrative

Returned for evaluation was an angiovac device.As received, the device was contaminated with bio matter.The outer balloon (membrane) was intact (bonded) to all four petals.One of the four petals appeared damaged/bent.The inner balloon contained what appeared to be dried contrast/bio material inside.The cannula contained one kink/indentation.There was no other damage, or any manufacturing related defects noted during the visual evaluation.A heise air pressure station was connected to the inflation lumen tubing via the female fitting - pressure was set to 14.7 psi (~1.0 atm).The balloon could not be inflated due to the occluded inflation line.A 0.014" guidewire was fed into the inflation line through the stopcock.The guidewire was able to be inserted until it hit the occlusion point.The customer's reported complaint for poor fluid flow due to cannula funnel not fully deploying/opening could not be confirmed due to the condition the sample was received in; inflation line was occluded with contrast mixture.When air pressure tested, the inner balloon did not inflate due to the occlusion in the inflation line.The inflation line needs to be able to fully inflate the inner balloon to evaluate the performance of the balloon funnel tip opening.It was observed that one of the balloon pedals was damaged/bent.Root cause of the balloon funnel opening issue could not be determined.In addition, a kink in the cannula was noted during sample evaluation which is likely a result of damage caused by the end user while trying to insert the cannula into the sheath.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: 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.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
• Type of Device: CATHETER, CANNULA & TUBING, CARDIOPULMONARY
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• MDR Report Key: 11824420
• MDR Text Key: 264297599
• Report Number: 1317056-2021-00098
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: H965251860
• UDI-Public: H965251860
• Combination Product (y/n): N
• PMA/PMN Number: K142593
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/10/2021

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?: 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: 05/10/2021
• Initial Date Manufacturer Received: 04/27/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 04/27/2021
• Supplement Dates FDA Received: 07/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR