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

Model Number PC1040RXC

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/17/2020

Event Type  Injury  

Manufacturer Narrative

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 17928289 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.

Event Description

As reported, the inner shaft of a 10mm x 40mm precise pro carotid self-expanding stent delivery system got separated, and the distal tip was damaged.There was no reported patient injury.Initially, a non-cordis embolic protection system was being removed but the filter was not able to be retracted into the precise pro.The physician used angiography, which showed the precise pro tip.The tip was confirmed in the image when the catheter was brought in to remove the non-cordis filter.Therefore, it was considered that the tip got separated and damaged in the guiding catheter.Therefore, the 8f guiding catheter (unknown) was guided up and was removed.The precise pro tip was found on the removed non-cordis embolic protection system.The stent was implanted after the procedure was completed.The fluoroscopic image which was taken when the precise pro was removed, confirmed that the tip of the precise pro was attached to the non-cordis embolic protection system.There was no resistance felt when the sds was removed.There were no complications for the patient after the procedure.No problems were identified with the precise pro before or during use.The separated distal end of the tip was also recovered.The doctor commented that there was no resistance when s/he removed the precise pro.This was a carotid artery stenting (cas) case.A balloon catheter (4.5*3, unknown) was used as pre-dilation for pta.There were no patient injuries.The product was stored, handled, and prepped per the instruction for use (ifu).There were no anomalies noted prior to inserting into the patient.The wire was not kinked or damaged in any way prior to insertion into the patient.The stent delivery system did not pass through any acute bends.There was no unusual force used at any time during the procedure.There was no difficulty or resistance noted while crossing the lesion with the stent.There was no resistance met while advancing or withdrawing the device.The device was not used for a chronic total occlusion (cto).There was no difficulty encountered while advancing/tracking the sds towards the lesion.The part was removed with an 8f guiding catheter.There are no procedural images available for review.The device will be returned for evaluation.

Manufacturer Narrative

The inner shaft of a 10mm x 40mm precise pro carotid self-expanding stent delivery system got separated, and the distal tip was damaged.Initially, a non-cordis embolic protection system was being removed but the filter was not able to be retracted into the precise pro.The physician used angiography, which showed the precise pro tip.The tip was confirmed in the image when the catheter was brought in to remove the non-cordis filter.Therefore, it was considered that the tip got separated and damaged in the guiding catheter.Therefore, the 8f guiding catheter (unknown) was guided up and was removed.The precise pro tip was found on the removed non-cordis embolic protection system.The stent was implanted after the procedure was completed.The fluoroscopic image which was taken when the precise pro was removed, confirmed that the tip of the precise pro was attached to the non-cordis embolic protection system.There was no resistance felt when the sds was removed.There were no complications for the patient after the procedure.No problems were identified with the precise pro before or during use.The separated distal end of the tip was also recovered.The doctor commented that there was no resistance when s/he removed the precise pro.This was a carotid artery stenting (cas) case.A balloon catheter (4.5*3, unknown) was used as pre-dilation for pta.The product was stored, handled, and prepped per the instruction for use (ifu).There were no anomalies noted prior to inserting into the patient.The wire was not kinked or damaged in any way prior to insertion into the patient.The stent delivery system did not pass through any acute bends.There was no unusual force used at any time during the procedure.There was no difficulty or resistance noted while crossing the lesion with the stent.There was no resistance met while advancing or withdrawing the device.The device was not used for a chronic total occlusion (cto).There was no difficulty encountered while advancing/tracking the sds towards the lesion.The part was removed with an 8f guiding catheter.There was no reported patient injury.The device was returned for analysis.Visual view, 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 along 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 throughout the whole section between the wire lumen and the tip.No other anomalies were observed.Pull test of tip and process tip were review during the manufacturing of this lot and no issues were noted that could be related to the reported complaint.Per microscopic analysis, sem results showed that the separated area of wire lumen of the precise pro rx us carotid syst unit presented evidence of elongations and a flared condition.Plastic deformation and diameter reduction were observed on braid wires.Also, ductile dimples were found on the separated braid wire surfaces.The elongations found on the wire lumen material, the ductile dimples and plastic deformations resulting in a diameter reduction found on the braid wires, are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the wire lumen material was induced to a tensile force that exceeded the wire lumen material yield strength prior to the separation.No other anomalies were observed during sem analysis.Infrared spectroscopy (ftir) was applied to the distal tip of the unit to analyze its composition.The proper polymer molecular structure of the distal tip has been confirmed.In addition, presence of molecular structure of adhesive was confirmed.A product history record (phr) review of lot 17928289 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿inner shaft - separated - in patient¿, ¿catheter tip - separated - in patient¿ and ¿outer sheath - distal tip - separated - in patient¿ were confirmed since the distal tip was observed separated.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 whole section between the wire lumen and the tip.Per microscopic analysis, (sem) results showed that the separated area of the wire lumen material of the unit presented evidence of elongations and flared condition.Braid wires on the wire lumen presented evidence of plastic deformation, diameter reduction and ductile dimples on their surface.The previously mentioned damages are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the wire lumen material might have been induced to a tensile force that exceeded the wire lumen material yield strength prior to the separation.Per infrared spectroscopy (ftir) analysis, on the distal tip of the unit, the proper polymer molecular structure of the distal tip has been confirmed and the presence of molecular structure of adhesive was also confirmed.Additionally, it is probable that procedural and or handling factors such as vessel characteristics (although unknown) may have led to the reported event.As well as the user¿s interaction with the device as evidence by product analysis (evidence of plastic deformation, diameter reduction and ductile dimples) are evidence that the device was induced to tensile force that exceeded the wire lumen material yield strength, prior to the separation.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.¿ however, it was determined by the engineering team that the tip separation was a manufacturing related, as the analyses couldn¿t conclusively determine if the correct amount of adhesive was applied through the entire section between the wire lumen and the tip.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): CARDINAL HEALTH MEXICO; av prado sur 150 2d0 piso; ciudad de mexico 11000 ; MX 11000
• MDR Report Key: 11162946
• MDR Text Key: 226559088
• Report Number: 9616099-2021-04195
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036556
• UDI-Public: 20705032036556
• 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: 03/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: PC1040RXC
• Device Catalogue Number: PC1040RXC
• Device Lot Number: 17928289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Initial Date Manufacturer Received: 12/24/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 03/05/2021
• Supplement Dates FDA Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8F GUIDING CATHETER.; EZ FILTER.; GUIDEWIRE.; UNK BALLOON CATHETER.; 8F GUIDING CATHETER; EZ FILTER; GUIDEWIRE; UNK BALLOON CATHETER
• Patient Outcome(s): Required Intervention