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	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.This device was received 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, the 6f standard (std) avanti plus catheter sheath introducer (csi) with guidewire (gw) no obturator (obt) snapped inside the patient.Additional information was received and the cannula was received separated at 1.9 cm from the hub, the other portion of the separated part was not received.There was no reported patient injury.The device will be returned for analysis.
Additional Manufacturer Narrative
As reported, the 6f standard (std) avanti plus catheter sheath introducer (csi) with guidewire (gw) no obturator (obt) snapped inside the patient.Additional information was received and the cannula was received separated at 1.9 cm from the hub, the other portion of the separated part was not received.There was no reported patient injury.The device was returned for analysis.One non-sterile si avanti+ 6f std w/gw no obt was received for analysis inside a plastic bag.Per visual analysis, only the cannula was received, the cannula was received separated at 1.9 cm from the hub, the other portion of the separated part was not received.No other abnormalities were observed.Per dimensional analysis, results were found within specification.Per microscopic analysis, the edge of the separated segment presented evidence of elongation; this characteristic suggest that the device was induced to stretching/pulling or twisting events that exceed the material yield strength prior to the separation.A product history record (phr) review of lot 17890312 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event by the customer as ¿cannula ¿ separated - in patient¿ was confirmed during analysis of the returned device.The device was received damaged with the cannula separated.The exact cause of the reported event could not be conclusively determined.Handling factors, such as stretching/pulling or twisting, may have contributed to the reported event as evidenced by the elongations found on microscopic analysis.According to the instructions for use (ifu) which is not intended as a mitigation of risk, do not use if package is open or damaged.Neither the phr review nor the product analysis suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective actions will be taken.

• 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 33014 ; MX 33014
• MDR Report Key: 10002833
• Report Number: 9616099-2020-03672
• Device Sequence Number: 16933493
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2020

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: 07/31/2022
• Device Model Number: 504606X
• Device Catalogue Number: 504606X
• Device Lot Number: 17890312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2020
• Initial Date Received by Manufacturer: 03/30/2020
• Supplement Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 05/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1