MAUDE Adverse Event Report: CORDIS CORPORATION AVANTI + 4F STD W/GW; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	504604X
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	12/29/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.It is unknown if the device will be returned for testing and evaluation.   additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
As reported, the 4f avanti plus standard (std) with guidewire (gw) catheter sheath introducer (csi) tore the artery during its introduction.Therefore, the artery had to be sutured and a new unknown device was used.The device will be returned for evaluation.
Additional Manufacturer Narrative
Complaint conclusion: as reported, the 4f avanti plus standard (std) with guidewire (gw) catheter sheath introducer (csi) tore the artery during its introduction.Therefore, the artery had to be sutured and a new unknown device was used.The product was not returned for analysis.A product history record (phr) review of lot 17955065 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿artery dissection¿ could not be confirmed as the product was not returned for analysis.The exact cause of the reported event could not be conclusively determined.Based on the information provided, it is impossible to determine what factors may have contributed to the reported event.Arterial dissection is a known and extensively documented potential complication of this type of procedure and is listed in the instructions for use (ifu) as such.Vessels that are resistant to angioplasty have a higher risk of complication during interventional procedures.Neither the phr review, nor the information available, suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: AVANTI + 4F STD W/GW
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11289902
• Report Number: 9616099-2021-04239
• Device Sequence Number: 3440959
• Product Code: DRE
• UDI-Device Identifier: 20705032009932
• UDI-Public: 20705032009932
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K970392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: 504604X
• Device Catalogue Number: 504604X
• Device Lot Number: 17955065
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 02/25/2021
• Patient Sequence Number: 1