MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX US CAROTID SYST; STENT, CAROTID

Catalog Number PC0740RXC

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2019

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the precise pro rx us carotid syst stent was partially deployed within the sterile packaging.There were no reported patient injuries.The product was stored, handled and prepped in accordance with the instructions for use (ifu).There was no visible damage to the package or the item.Additional procedural details were requested but are unknown.

Manufacturer Narrative

This report was a duplicate of report 9616099-2019-03084, therefore no additional information will be forthcoming under this report 9616099-2019-03090.

• Brand Name: PRECISE PRO RX US CAROTID SYST
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8813654
• MDR Text Key: 151870468
• Report Number: 9616099-2019-03090
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036464
• UDI-Public: 20705032036464
• Combination Product (y/n): N
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: PC0740RXC
• Device Lot Number: 17771397
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1