MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / NAVILYST MEDICAL; CONVENIENCE KIT

Catalog Number	H9656560007841
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	Cardiac Arrest (1762)
Date of Event	10/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It has been indicated that the used device will be returned to angiodynamics for evaluation.Upon receipt of the device, and completion of the investigation, a supplemental medwatch will be submitted.Questions were asked of the complaint reporter to get additional details of the adverse event.Air bubbles were not observed in the manifold prior to contrast injection.Air could not be seen entering the coronary artery.After an injection, the patient went into asystole which required the resuscitation measures of cpr and medication (adrenaline).It was not until after the cardiac event that the end user noticed air in the fluid delivery set line near the fitting with the manifold.No air was visually confirmed on fluoroscopy to have been injected into the patient.The root cause of the asystole was not confirmed but end user believed it to be a result of air injection due to air noticed in the fds line.Air in the fds line was reported by the end user to be a result of kinks in the tubing but that has not been confirmed.The end user indicated that the episode of asystole occurred just after the injection into the rca (right coronary artery).This particular vessel is associate with the sa node (the pacemaker of the heart).Any interruption in blood flow to this vessel can cause bradycardia or asystole.For instance, a deep seeded catheter past the ostium of the vessel could potentially cause this event.The root cause of the asystole may have been a result of other clinical issues during the procedure.(b)(4).
Event or Problem Description
As reported by angiodynamics' distributor in the (b)(4), hospital reported that kinked tubing in a convenience kit resulted in air bubbles being injected into the right coronary artery during a diagnostic coronary angiography procedure.Resuscitation of the patient was performed, with success, as the patient experienced asystole.The patient was given adrenaline.The patient's rhythm prior to the asystole was sinus rhythm.The patient was in asystole for approximately one minute before the return of circulation.The air bubbles were not seen during prep, nor were they seen in the manifold prior to injection.No follow-up care was required, as the patient totally recovered from the event in the cath lab.The used device will be returned to angiodynamics for evaluation.
Additional Manufacturer Narrative
A review of the device history records was performed for the indicated 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.The recent angiodynamics complaint report was reviewed for the convenience kit product family and the failure mode, "device - air bubbles." no adverse trend was identified.As received, the tubing on the returned fluid delivery set from the kit was kinked greater than 50% of the tubing id.Multiple kinks of less than 50% of the tubing id were also noted in different locations.(as a reference, the pre-sterile specification for kinked tubing per angiodynamics procedures is that kinked tubing must not be greater than 50% of the tubing id.).The end user hospital's complaint description is confirmed for kinked tubing.Tubing was kinked greater than 50% of the tubing id, which is greater than the allowable pre-sterile specification.Follow-up questions were asked of the end user, and a correlation between air injected into the patient and the asystole could not be confirmed, i.E.Air was not observed being injected into the patient - this was inferred.In addition, a correlation between kinked tubing and air injected into the patient could not be confirmed.A definitive root cause of the kinked tubing could not be determined.Potential root causes include: the responsible angiodynamics employees failed to properly visualize or package the product in such a way as to prevent kinking.All employees involved in the packaging of the reported kit lot have been made aware of this event and have been retrained on the applicable packaging and inspection procedures.This kit is provided non-sterile to a custom procedure tray packager (medica b.V.) handling of the pre-sterile kits by the tray packager and/or placement of the kits within their tray packs could have contributed to the kinking.The directions for use provided with the product states the following: "examine product carefully for entrapped air and fully debubble prior to injection to minimize the potential for embolism and in rare instances death." (b)(4).

• Brand Name: ANGIODYNAMICS / NAVILYST MEDICAL
• Common Device Name: CONVENIENCE KIT
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7032397
• Report Number: 1317056-2017-00093
• Device Sequence Number: 11007407
• Product Code: OEZ
• UDI-Device Identifier: H9656560007841
• UDI-Public: H9656560007841
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2018

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: Physician
• Device Expiration Date: 04/25/2020
• Device Catalogue Number: H9656560007841
• Device Lot Number: 5183889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2017
• Supplement Date Received by Manufacturer: 10/18/2017
• Initial Report FDA Received Date: 11/15/2017
• Supplement Report FDA Received Date: 01/23/2018
• 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: Required Intervention