MAUDE Adverse Event Report: CORDIS CORPORATION SI AVANTI+ 9F STD W/GW NO OBT; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	504609X
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device will be returned for testing and evaluation.   the product was not returned for analysis.The device history review (dhr) could not be completed.
Event or Problem Description
As reported, a si avanti plus (std w/gw no obt) had an oily substance around the ring so another device was retrieved to use for the procedure.The product will be returned for analysis.
Additional Manufacturer Narrative
Additional information was provided: this device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, a si avanti plus (std w/gw no obt) had an oily substance around the ring so another device was retrieved to use for the procedure.The product will be returned for analysis.This product was never used on a patient.Upon opening the package, the substance was noticed and not put to use.No packaging was damaged or altered before noticing the substance.
Additional Manufacturer Narrative
Complaint conclusion: as reported, a si avanti plus (std w/gw no obt) had an oily substance around the ring so another device was retrieved to use for the procedure.The product will be returned for analysis.This product was never used on a patient.Upon opening the package, the substance was noticed and not put to use.No packaging was damaged or altered before noticing the substance.A non-sterile unit of product si avanti+ 9f std w/gw no obt was received inside of a clear plastic bag.Parts returned were the csi and the vessel dilator.The vessel dilator was already inserted into the cannula of the csi.The device was unpacked and laid it on a tray to proceed with the evaluation.An oily substance was observed on the cap of the csi.No other damages or anomalies were observed neither on the csi nor on the vessel dilator.The vessel dilator was placed under a vision system in order to amplify the cap area.A presence of an oily substance on the cap was confirmed.The part was submitted to analytics department.Infrared spectroscopy was applied to determine composition of oily substance found on the ring and cap from the si avanti device.Spectra results clearly show that the material is composed of mdx medical fluid, with an oily appearance that coats the device.A product history record (phr) review of lot 17816690 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿packaging/pouch/box foreign material in sterile package¿ was not confirmed since the material (mdx) is inherent to the manufacturing process of the device.However, as the customer is not aware of the manufacturing process of the unit, this material could appear as foreign, and the presence of the substance was confirmed.According to the instructions for use, which is not intended as a mitigation, ¿do not use if package is open or damaged.¿ standard clinical practice calls for inspection of the device and packaging prior to use in the patient.If the user notes anything unusual, they are urged to discontinue use of the device and exchange for another.Neither the phr review nor the product analysis suggests that the reported event could be a failure or defect related the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: SI AVANTI+ 9F STD W/GW NO OBT
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 8581953
• Report Number: 9616099-2019-02897
• Device Sequence Number: 2359771
• Product Code: DRE
• UDI-Device Identifier: 20705032010198
• UDI-Public: 20705032010198
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K970392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/11/2019

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: 09/30/2021
• Device Model Number: 504609X
• Device Catalogue Number: 504609X
• Device Lot Number: 17816690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Received by Manufacturer: 04/11/2019
• Supplement Date Received by Manufacturer: 05/15/2019; 06/21/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 06/10/2019; 07/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1