MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 8X30; STENT, CAROTID

Catalog Number PC0830XCE

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/09/2019

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot (17736184) presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, after the precise pro rx self-expanding stent (ses) was removed from packaging, it was found the stent have been released.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.There was no difficulty removing the stylet or any of the sterile packaging components.The device was prepped according to instructions for use (ifu).The stent was released when flushing the device.There were no kinks or other damages noted prior to inserting the product into the patient.The damaged was noted during prep.There was no other damaged found on the precise stent.The device was not used in patient.The device will be return for analysis.

Manufacturer Narrative

After further review of additional information received the following sections pma/510k, if follow-up, what type, device evaluated by mfr have been updated accordingly.After the precise pro rx self-expanding stent (ses) was removed from packaging, it was found the stent have been released.There was no reported patient injury.The device was stored and handled per the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.There was no difficulty removing the stylet or any of the sterile packaging components.The device was prepped according to instructions for use (ifu).The stent was released when flushing the device.There were no kinks or other damages noted prior to inserting the product into the patient.The damaged was noted during prep.There was no other damaged found on the precise stent.The device was not used in patient.There was no patient injury.The device was returned for analysis.One non-sterile precise pro rx 8x30 was received for analysis inside a plastic bag.No original packaging was returned.The valve of the unit was received locked/closed.Per visual analysis, the stent was observed already deployed and was not returned.No other anomalies were found.Functional analysis could not be performed due to the stent already being deployed.A product history record (phr) review of lot 17736184 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent delivery system (sds) - deployment difficulty -premature/during prep¿ was confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.Based on the limited information available for review, handling factors may have contributed to the event although there is no evidence to support that likelihood.According to the instructions for use, which is not intended as a mitigation of risk, ¿extract the stent delivery system from the tray.Examine the device for any damage.Evaluate the distal end of the catheter to ensure that the stent is contained within the outer sheath.Do not use if the stent is partially deployed." neither the phr review nor the product analysis 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: PRECISE PRO RX 8X30
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 8655561
• MDR Text Key: 146655798
• Report Number: 9616099-2019-02982
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: PC0830XCE
• Device Lot Number: 17736184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2019
• Date Manufacturer Received: 06/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1