MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 9X40; STENT, CAROTID

Model Number PC0940XCE

Device Problems Difficult to Open or Remove Packaging Material (2922); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/13/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17890332 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.This device is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, it was found that the inner packaging of a 9x40 precise pro rapid exchange (rx) self-expanding stent (ses) was damaged during operation.There was no obvious damage on the outer package, however, the integrity of the sterile pouch was compromised.There was no reported patient injury.The device was opened in a sterile field.The seal of the inner package was not purposely opened in anticipation of use and when not used was reshelved.The device was stored in the lab according to the ifu.There was no actual product damage.The device will be returned for evaluation.Images are available for review.

Manufacturer Narrative

It was found that the inner packaging of a precise pro 9x40 rapid exchange (rx) self-expanding stent (ses) was damaged during operation.There was no obvious damage on the outer package, however, the integrity of the sterile pouch was compromised.The device was opened in a sterile field.The seal of the inner package was not purposely opened in anticipation of use and when not used was re-shelved.The device was stored in the lab according to the ifu.There was no actual product damage.There was no reported patient injury.The device was returned for analysis and three pictures were also received for analysis.Per picture analysis: three pictures related to the reported failure were attached by the customer at the complaint file case-(b)(4) as part of the first picture, it can be observed a precise pro rx product inside the pouch.As part of the label placed in the pouch the following information can be read: lot # 17890332, catalog #pc0940xce and use by date 2021-07-31.During analysis of picture 2 & 3, it can be noticed the product placed in the tray inside the pouch.In addition, an open seal/pouch can be observed.No other anomalies of the product can be noticed on the attached pictures.Per visual analysis: one non-sterile precise pro rx 9x40 was received for analysis inside a plastic bag.No original packaging was returned.The valve of the unit was received unlocked.Per visual analysis, stent was observed not deployed from the unit.No anomalies were observed.A product history record (phr) review of lot 17890332 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported packaging/pouch/box - compromised sterility - seal open¿ was not confirmed since the original packaging/pouch was not returned for its analysis.Although pictures were received where an open seal can be observed, the exact root-cause for its opening couldn¿t be conclusively determine during this analysis.Procedural and or handling factors such as shipping and delivery conditions as well as how the device was stored in the lab may have led to the reported events.According to the instructions for use, which are not intended as a mitigation of risk, ¿after careful inspection of the pouch looking for damage to the sterile barrier, carefully peel open the pouch and extract the stent delivery system from the tray.Examine the device for any damage.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.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, image reviews nor the product analysis suggests that the reported event could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: PRECISE PRO RX 9X40
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 10836366
• MDR Text Key: 216183273
• Report Number: 9616099-2020-04055
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: PC0940XCE
• Device Catalogue Number: PC0940XCE
• Device Lot Number: 17890332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Date Manufacturer Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1