MAUDE Adverse Event Report: CARDINAL HEALTH MEXICO PRECISE PRO RX US CAROTID SYST; STENT, CAROTID

Catalog Number PC1040RXC

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

Product history review could not be performed since complaint lot is unknown.Additional information is pending and will be sent in upon 30 days after receipt.

Event Description

As reported, the distal tip of a 10 x 40 precise self-expanding stent delivery system was separated.There was no reported patient injury.The device will be returned for evaluation.

Manufacturer Narrative

The distal tip of a precise pro rx 10mm x 40mm self-expanding stent delivery system was separated.The device broke off inside the artery after deployment of the stent.The angioguard and stent delivery system were removed together, and the filter basket was used to capture the broken piece of the stent delivery device.There was no reported patient injury.The device was returned for analysis.Per visual review, one non-sterile precise pro rx us carotid syst was received for analysis inside a plastic bag.No original packaging was returned.The valve of the unit was received opened.Per visual analysis, the stent of the unit was observed deployed but was not received along the unit.The wire lumen was observed separated from the distal tip.Distal tip was not received.Since the distal tip was not received, visual analysis couldn¿t determine if the correct amount of adhesive was applied through the entire section between the wire lumen and the tip.A kink was observed on the wire lumen near to the pod.No other anomalies were observed.Pull test of tip and process tip were reviewed and no issues were noted that could be related to the reported complaint.A product history record (phr) review of lot 17934634 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿catheter tip - separated - in patient¿ was confirmed since the distal tip was observed separated from the wire lumen.Nevertheless, the distal tip was not returned for its analysis.Since the distal tip was not received, visual analysis couldn¿t determine if the correct amount of adhesive was applied through the entire section between the wire lumen and the tip.After the physical evaluation of the unit, it was determined by the engineering team (pet) that the tip separation was a manufacturing related.As the physical evaluation of the unit couldn¿t conclusively determine if the correct amount of adhesive was applied through the entire section between the wire lumen and the tip.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.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Note: if any resistance is met during delivery system withdrawal, advance the outer sheath until the outer sheath marker contacts the catheter tip and withdraw the system as one unit.¿ the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, a corrective/preventive action will be taken at this time.

Manufacturer Narrative

Section b5: addendum for additional information has been received: the device broke off inside the artery after deployment of the stent.The angioguard and stent delivery system were removed together.The device has been returned for evaluation, but the manufacture report is not yet available.A review of the device history record (dhr) associated with lot 17934634 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported event.Additional information is pending and will be sent in upon 30 days after receipt.

• Brand Name: PRECISE PRO RX US CAROTID SYST
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 11088429
• MDR Text Key: 224521251
• Report Number: 9616099-2020-04160
• Device Sequence Number: 1
• Product Code: NIM
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• 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 Catalogue Number: PC1040RXC
• Device Lot Number: 17934634
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ANGIOGUARD