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

Model Number PC0930RXC

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 01/04/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 17934632 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, the 9mm x 30mm precise pro rapid exchange (rx) carotid stent system was implanted.After that, the physician noticed that the distal end of the device was separated.It was difficult to remove the separated part, but it was removed together when the physician removed a non-cordis filter wire.There was no patient injury reported and the procedure was completed.This was a carotid artery stenting (cas) case.The product was stored and handled according to the instructions for use (ifu).The device was prepped according to the ifu.No damages were noted to the device prior to using.There was no difficulty experienced in prepping the device.The precise pro was used as per the instructions for use (ifu).The target site was the right internal carotid artery which was 75 percent stenosed.The access site was the left femoral artery.It was verified prior to insertion that stent was contained within the outer sheath/introducer of the system.The device was not used for a chronic total occlusion (total occlusion >3 months).The device will be returned for evaluation together with non-cordis filter wire.

Manufacturer Narrative

A precise pro 9mm x 30mm rapid exchange (rx) carotid stent system was implanted.After that, the physician noticed that the distal end of the device was separated.It was difficult to remove the separated part, but it was removed together when the physician removed a non-cordis filter wire.This was a carotid artery stenting (cas) case.The product was stored and handled according to the instructions for use (ifu).The device was prepped according to the ifu.No damages were noted to the device prior to using.There was no difficulty experienced in prepping the device.The precise pro was used as per the instructions for use (ifu).The target site was the right internal carotid artery which was 75 percent stenosed.The access site was the left femoral artery.It was verified prior to insertion that stent was contained within the outer sheath/introducer of the system.The device was not used for a chronic total occlusion (total occlusion >3 months).There was no patient injury reported and the procedure was completed.The device was returned for analysis.Visual review: one non-sterile precise pro rx us carotid syst was received for analysis inside a plastic bag.No original packaging was returned.A non-cordis embolic protection system was received inside the same bag.Also, an unknown stopcock was observed attached to the unit.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 observed inserted into the non-cordis embolic protection system received.An acceptable adhesive quantity was observed inside the tip¿s glue port.Nevertheless, due to the condition received of the tip, visual analysis couldn¿t determine if the correct amount of adhesive was applied through the entire section between the wire lumen and the tip.No other anomalies were observed.A product history record (phr) review of lot 17934632 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.An acceptable adhesive quantity was observed inside the tip¿s glue port.Nevertheless, due to the condition received of the tip, visual analysis couldn¿t determine if the correct amount of adhesive was applied throughout 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 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.

• Brand Name: PRECISE PRO RX US CAROTID SYST
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• MDR Report Key: 11260051
• MDR Text Key: 230949806
• Report Number: 9616099-2021-04219
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036518
• UDI-Public: 20705032036518
• 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: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: PC0930RXC
• Device Catalogue Number: PC0930RXC
• Device Lot Number: 17934632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2021
• Date Manufacturer Received: 03/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FILTER WIRE (BOSTON SCIENTIFIC)
• Patient Age: 76 YR