MAUDE Adverse Event Report: CORDIS CORPORATION SI AVANTI + CSI 4F 7.5CM PED; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	504604S
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	10/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
During use it was reported that there was a possibility of dissecting the femoral artery with the dilator tip of the avanti sheath.The device is available for analysis.
Additional Manufacturer Narrative
This is an update to the report to state that the device will not be returned for analysis.During use it was reported that there was a possibility of dissecting the femoral artery with the dilator tip of the avanti sheath.No other information was provided.The product was not returned for analysis.A device history record review of lot 17658781 was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan and that there were no anomalies during the manufacturing.Based on the limited information provided, it is not possible to draw a conclusion about a clinical relationship between the device and the event.Without the return of the device for analysis, the reported customer complaint could not be confirmed and no determination of possible contributing factors could be made.Dissection is a well-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 intimal dissection during interventional procedures.This does not represent device malfunction.Based on the available information there is no evidence to suggest that the event was design or manufacturing related.The dhr reviews does not suggests that the reported failures could be related to the manufacturing process of the unit.Therefore no corrective action will be taken.

• Brand Name: SI AVANTI + CSI 4F 7.5CM PED
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33104
• MDR Report Key: 8079652
• Report Number: 9616099-2018-02536
• Device Sequence Number: 1500511
• Product Code: DRE
• UDI-Device Identifier: 20705032009918
• UDI-Public: 20705032009918
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K970392
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2018

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: 02/29/2020
• Device Model Number: 504604S
• Device Catalogue Number: 504604S
• Device Lot Number: 17658781
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/24/2018
• Supplement Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 12/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1