MAUDE Adverse Event Report: NUMED, INC. COVERED AND MOUNTED CP STENT; AORTIC STENT

Model Number	428
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was returned for review.The covering is completely detached from the stent and one end of the stent has been expanded.The report states that the physician did not use the hemostasis tools provided by numed for the introduction of the device into the introducer.The instructions for use states "use of the tools supplied with stent is necessary to defeat the hemostasis valve without damaging the stent or covering." it is probably that the covering detached because the provided tools were not used as is specified in the instructions for use.
Event or Problem Description
As per the report from bis "physician stated that the covering was not right on this item and the stent would not fo into the introducer properly." additional information from bis was sent on 7/11/2017."in an email from the account: physician used saline during prep.The hemostasis tools provided by numed were not used.A 14fr mullins sheath was used.The covering never entered the introducer or the patient.The covering was very loose on the distal tip - not right.Regarding the introducer - the stent would not go in - thus it was not proper.".

• Brand Name: COVERED AND MOUNTED CP STENT
• Common Device Name: AORTIC STENT
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• MDR Report Key: 6725904
• Report Number: 1318694-2017-00020
• Device Sequence Number: 18995892
• Product Code: PNF
• UDI-Device Identifier: 04046964899607
• UDI-Public: 04046964899607
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P150028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/19/2017

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: Physician
• Device Expiration Date: 08/31/2019
• Device Model Number: 428
• Device Catalogue Number: CMCP031
• Device Lot Number: CMCP-0576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2017
• Initial Report FDA Received Date: 07/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1