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

Model Number 25194

Device Problems Loss of or Failure to Bond (1068); Detachment of Device or Device Component (2907)

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

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that the disposable 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.Reference (b)(4).

Event Description

An angiodynamics territory manager reported an issue with an angiovac c180 with obturator.After the initial typical setup and prep of the angiovac circuit, the brand new cannula was opened on the table in sterile fashion.Upon opening the cannula it was noted that the stopcock on the outer sleeve was not attached at all, it appeared as if it was not constructed properly during manufacturing process.Since this was the first time i (b)(6) experienced this, i told the physician to give me a minute so that i could ask the seniors on the clinical team if they've experienced this phenomenon.I called (b)(6), and he suggested that he's seen physicians in the past place a tegaderm over the port to fix the issue.I mentioned that to the physician and he proceeded to use petroleum jelly / "bacitracin was his exact words" on the port disregarding my advice at the time.Physician then inserted the angiovac came on pump and shortly after we experienced micro bubbles in the circuit and saw micro bubbles in the right atrium.We then came off pump, cleared the circuit of bubbles and then he decided to place a tegaderm on the affected area.The patient tolerated the micro bubbles without any hemodynamic change.At this point the staff and anesthesiologist in the case didn't want to place the device back in the patient with just the tegaderm on it.I then mentioned since there was a c20 device at the facility that we could use the outer sleeve of it with the c180 cannula to alleviate the compromised original outersleeve provided with the c180.The angiovac with the new outersleeve was inserted into the patient and the case proceeded without any issues.The patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.It was indicated that the reported device is not available to be returned to the manufacturer for evaluation.

Manufacturer Narrative

As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.However, the customer supplied a picture of the reported defect; confirming the tubing was detached from bond joint.In reviewing the photograph, it was unuable to determined whether the tubing was pulled out of the bond joint or if the tubing was fractured/broken.The customer's reported complaint description is confirmed for stopcock side port tubing detached based on the picture supplied by the customer.However, without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A potential root cause for this failure mode could be that the manufacturing employee for this process step failed to properly bond the angiovac side arm assembly the manufacturing procedure for this product.As a correction, the manufacturing employee who performed the side port tubing bonding sequence for this lot number was made aware of this event and wase re-trained on proper assembly procedures.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: dfu is supplied to the customer.The dfu contains warning that states: warnings inspect product prior to, during, and after use, to ensure that no damage to the product has occurred.Failure to inspect could result in injury to patient or user.Carefully examine the circuit for leaks before and during use.Leakage may result in loss of sterility, blood loss or air embolism.If leakage is observed replace the circuit, the leaking component or tighten the leaking connection.Instructions for use and manuals for all related extracorporeal circulatory devices should be read prior to use, including but not limited to the angiovac cannula, centrifugal pump head, control console and bubble trap.Operational instructions: visually inspect the circuit for any obvious defects in materials or assembly and ensure all protective caps are in place.Gently connect "y" circuit hub to female connector until it clicks.Remove reinfusion cannula connection and spare parts pouch and place on table.Fully insert touhy adaptor into red touhy.Tighten red touhy until finger tight.Tighten touhy adaptor until finger tight.Visually inspect entire circuit for leaks.As with all medical devices, this device is to be used by or under the direction of trained physicians only.User assumes responsibility for any variations in the extracorporeal circulation/procedures that could compromise the intended use of this device.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: 11028169
• MDR Text Key: 222080123
• Report Number: 1317056-2020-00189
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: H965251940
• UDI-Public: H965251940
• 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: 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Model Number: 25194
• Device Catalogue Number: 25194
• Device Lot Number: 5646922
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR