MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 9X40; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number PC0940XCE

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/14/2022

Event Type  Injury  

Manufacturer Narrative

The product history review is expected but has not been completed.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the stent of a 9mm x 40mm precise pro rx stent system became embedded and therefore could not be deployed smoothly.The stent was forced out of the catheter to complete the deployment.There was an unknown patient injury.The hospital reported it as an adverse event to the china nmpa directly.The device will not be returned for evaluation.

Manufacturer Narrative

The code has changed from "stent delivery system (sds)-ses ~ deployment difficulty- inaccurate placement" to "stent delivery system (sds)-ses ~ deployment difficulty".Therefore, this event no longer meets the definition of a malfunction that requires submission of a regulatory report.No additional reports will be forthcoming.This case is no longer consider reportable.

• Brand Name: PRECISE PRO RX 9X40
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 16141531
• MDR Text Key: 307151617
• Report Number: 9616099-2023-06213
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PC0940XCE
• Device Catalogue Number: PC0940XCE
• Device Lot Number: 18113298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1