MAUDE Adverse Event Report: CORDIS CORPORATION SI AVANTI+ 6F STD W/GW NO OBT; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	504606X
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information to include phone number: (b)(4).During use, the side port arm of the avanti sheath had disconnected from the sheath causing excess blood flow from sheath after insertion.No other information was provided.Given the age of the case no additional information was obtain.The device was not returned for analysis.A product history record (phr) review of lot 17485895 revealed no anomalies or non-conformance's during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿side port extension separated during use¿ could not be confirmed as the device was not returned for analysis.The exact cause of the issue experienced could not be determined.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the separated side port.However, it could be related to handling factors.According to the instructions for use, which is not intended as a mitigation, ¿aspirate from the sideport extension to remove any potential air.After aspiration and flushing, consider establishing a heparinized solution or suitable isotonic solution via the sideport extension.The addition of a heparinized saline drip via the sideport can help in the prevention of thrombus formation¿.Neither the phr nor the information available for review suggest a design or manufacturing related cause for the issue experienced.Therefore, no corrective or preventative actions will be taken at this time.
Event or Problem Description
During use, the side port arm of the avanti sheath had disconnected from the sheath causing excess blood flow from sheath after insertion.No other information was provided.

• Brand Name: SI AVANTI+ 6F STD W/GW NO OBT
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 8493366
• Report Number: 9616099-2019-02837
• Device Sequence Number: 1784098
• Product Code: DRE
• UDI-Device Identifier: 10705032010054
• UDI-Public: 10705032010054
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K970392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/08/2019

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: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: 504606X
• Device Catalogue Number: 504606X
• Device Lot Number: 17485895
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 04/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1