MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; CARDIOVASCULAR PROCEDURE KIT

Catalog Number	H965652001911
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Codes	Air Embolism (1697); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/29/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As no lot number was provided, a ship history report (shr) was generated for item number h965652001911 in order to determine the last three lots shipped to the reporting hospital in the six months prior to the procedure date.The device history records for the lots obtained through the shr were reviewed 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 september 2016 angiodynamics complaint report was reviewed for the convenience kits product family and the failure mode, "air injected." no adverse trends were identified.The reported complaint description cannot be confirmed; no sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.Possible root cause may be that the end user did not adequately secure connections between the manifold and components or the device they were connecting to were not "finger tightened" prior to use as it is stated in the dfu provided to the end user in the reported kit.The dfu contains the following statements, "ensure that you are making secure connections when using this device to prevent the introduction of air into the system that could result in embolism and in rare instances of death.All connections should be finger tightened.Over tightening can cause cracks and leaks to occur that could result in embolism and or exposure to biohazards.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).Device discarded at hospital.
Event or Problem Description
As reported by cath lab manager, during use of an angiodynamics' convenience kit in a heart catheterization procedure, a patient was thought to have had air injected into one of their coronary arteries.The physician perceived that air came from one of the lines connected to the manifold.The report concluded that the patient " is and was completely stable." the used product was discarded at the hospital.

• Brand Name: ANGIODYNAMICS
• Common Device Name: CARDIOVASCULAR PROCEDURE KIT
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 6051878
• Report Number: 1317056-2016-00158
• Device Sequence Number: 77197
• Product Code: OEZ
• UDI-Device Identifier: H965652001911
• UDI-Public: H965652001911
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2016

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
• Operator of Device: Physician
• Device Catalogue Number: H965652001911
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2016
• Initial Report FDA Received Date: 10/24/2016
• 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: Other