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

Model Number PC0840RXC

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2020

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17936245 presented no issues during the manufacturing process that can be related to the reported event.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, a crack was found on the tip of an 8mm x 40mm precise pro rapid exchange (rx) carotid self expanding stent (ses) before use, during prep.Another precise product was therefore used to complete the procedure.The procedure was completed successfully without patient injury.The target lesion was carotid artery (ca).There was no vessel angulation, calcification or tortuosity.The percentage of stenosis was between 50-60%, the product was stored properly according to 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.The integrity of the sterile pouch was not compromised.There was no difficulty removing the stylet or any of the sterile packaging components.The product was inspected before use but did not appear to be normal.There were no kinks or other damages noted prior to inserting the product into the patient.The device was not pulled from the packaging by the hub and if so where any anomalies noted at this time.The device was prepped according to instructions for use (ifu) and prepped normally (maintained negative pressure).The device will be returned for evaluation.There was no other product issue noted either at the account after the procedure or prior to shipping for inspection.

Manufacturer Narrative

After further review of additional information received the following sections g4, g7, h2, h3 and h6 have been updated according.A crack was found on the tip of a precise pro 8mm x 40mm rapid exchange (rx) carotid self expanding stent (ses) before use, during prep.Another precise product was therefore used to complete the procedure.The target lesion was carotid artery (ca).There was no vessel angulation, calcification or tortuosity.The percentage of stenosis was between 50-60%, the product was stored properly according to 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.The integrity of the sterile pouch was not compromised.There was no difficulty removing the stylet or any of the sterile packaging components.The product was inspected before use but did not appear to be normal.There were no kinks or other damages noted prior to inserting the product into the patient.The device was not pulled from the packaging by the hub and if so where any anomalies noted at this time.The device was prepped according to instructions for use (ifu) and prepped normally (maintained negative pressure).There was no other product issue noted either at the account after the procedure or prior to shipping for inspection.The procedure was completed successfully without patient injury.The product was returned for analysis.One non-sterile precise pro rx us carotid syst stent delivery system was received for analysis inside a plastic bag.No original packaging was returned.The valve of the unit was received locked.Per visual analysis, stent was not deployed from the unit.No anomalies were observed on the unit.Per microscopic analysis, no damages were observed on the distal tip of the unit.A product history record (phr) review of lot 17936245 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter tip - cracked - prior to use¿ was not confirmed since no damages were observed on the distal tip of the unit.Neither the phr review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.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¿.Nonetheless, the cause of the catheter tip-cracked on the unit could not be conclusively determined during the analysis since no damages were observed on the distal tip of the unit.Procedural and or handling factors such as the user¿s interaction during preparation may have led to the reported event.Neither the product analysis nor the phr review suggests that the event experienced by the customer is related to the manufacturing process.Therefore, no corrective or preventive actions will be taken at this time.

• 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: 10434311
• MDR Text Key: 203872635
• Report Number: 9616099-2020-03853
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036495
• UDI-Public: 20705032036495
• Combination Product (y/n): N
• PMA/PMN Number: P030047
• 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: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: PC0840RXC
• Device Catalogue Number: PC0840RXC
• Device Lot Number: 17936245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1