MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; CONVENIENCE KIT

Catalog Number	H9656062093161
Medical Device Problem Code	Air Leak (1008)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device from the reported event has been returned for evaluation, however the device evaluation has not yet been conducted.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported by (b)(6) distributor in the (b)(6), while using a convenience kit during a pci procedure, the end user noted leakage at the bonded connection site between the manifold and the contrast injection line resulting in air entering the system.The two components were crooked at the bonded connection.No air injection or patient injury was reported.
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 perceptor dts and manifolds product family and the failure mode "air bubbles noted." no adverse trend was identified.The manifold bonded assembly was returned with the flexcil line at an angle/crooked.Visual inspection of the bond site showed no signs of any molding defects that would cause this type damage.The bond between the female of the contrast injection line and the rotating adaptor of the manifold was clear and secure, i.E.No evidence of excess bonding agent.The end user's complaint description is confirmed, as the returned sample failed leak testing.Based on the sample evaluation results and process controls in place to address this failure mode, possible root causes include the end user trying to tighten the bonded connection, handling damage during transit or that the responsible employees did not apply enough chemical adhesive when attaching the rotating adaptor.No other damage was noted to the returned sample.The employees involved in the assembly of the reported device lot have been made aware of this event and the applicable bonding procedure has been reviewed with them.((b)(4).

• Brand Name: ANGIODYNAMICS
• Common Device Name: CONVENIENCE KIT
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 5809792
• Report Number: 1317056-2016-00108
• Device Sequence Number: 18982389
• Product Code: OEZ
• UDI-Device Identifier: H9656062093161
• UDI-Public: H9656062093161
• 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): 07/01/2016

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
• Operator of Device: Other Health Care Professional
• Device Expiration Date: 02/28/2019
• Device Catalogue Number: H9656062093161
• Device Lot Number: 4999127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/20/2016
• Supplement Report FDA Received Date: 01/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1