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

Catalog Number	PC0740RXC
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem 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.
Additional 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
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8813654
• Report Number: 9616099-2019-03090
• Device Sequence Number: 2471501
• Product Code: NIM
• UDI-Device Identifier: 20705032036464
• UDI-Public: 20705032036464
• Combination Product (Y/N): N
• Initial Reporter State: FL
• PMA/510(K) Number: P030047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2019

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: 03/31/2020
• Device Catalogue Number: PC0740RXC
• Device Lot Number: 17771397
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 06/24/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 08/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1