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

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).This device is available for analysis but has not yet been received.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

After a 6mm x 30mm precise pro rapid exchange stent was implanted in the common carotid artery overlapping another stent, the distal tip was not there when the stent delivery system (sds) was removed from the patient.The physician was convinced that it must be on the non-cordis wire, so post-dilation of the stent was done.The distal tip of the sds which was released from the precise stent was on the tip of the balloon used for post-dilatation.The wire with the catheter tip was easily removed from the patient by pulling it out the patient.There was no patient injury reported and the procedure was completed.The device will be returned for analysis.The intended procedure was carotid artery stenting.The 75% occluded lesion was about 4cm in length in a -6mm~9mm vessel diameter.There was no calcification or vessel tortuosity.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The product was stored, handled, inspected and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.A 9f sheath introducer and a 9f guiding catheter were used in the procedure.The stent delivery system did not pass through any acute bends.There was no difficulty encountered while advancing/tracking the sds towards the lesion.The user maintained a fixed inner shaft position during deployment.There was no unusual force applied during deployment of the stent.Additional patient and procedural details were requested but were not provided by the account.

Manufacturer Narrative

After a 6mm x 30mm precise pro rapid exchange stent was implanted in the common carotid artery overlapping another stent, the distal tip was not there when the stent delivery system (sds) was removed from the patient.The physician was convinced that it must be on the non-cordis wire, so post-dilation of the stent was done.The distal tip of the sds which was released from the precise stent was on the tip of the balloon used for post-dilatation.The wire with the catheter tip was easily removed from the patient by pulling it out the patient.The intended procedure was carotid artery stenting.The 75% occluded lesion was about 4cm in length in a -6mm~9mm vessel diameter.There was no calcification or vessel tortuosity.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The product was stored, handled, inspected and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.A 9f sheath introducer and a 9f guiding catheter were used in the procedure.The stent delivery system did not pass through any acute bends.There was no difficulty encountered while advancing / tracking the sds towards the lesion.The user maintained a fixed inner shaft position during deployment.There was no unusual force applied during deployment of the stent.There was no patient injury reported and the procedure was completed.The device was returned for analysis.One non-sterile pc0930rx precise pro rx us carotid syst stent delivery system was received for analysis inside a plastic bag.Per visual analysis, the delivery system was already actuated / stent deployed.The valve of the precise pro rx was open.The stent of the unit was not received for analysis.Per catheter tip- separated reported event, the device was thoroughly inspected, and no anomalies were observed.Per functional analysis, pull test of tip and process tip were review during the manufacturing of this lot and no issues were noted that could be related.Per microscopic analysis, the tip was inspected under the vision system and no anomalies were observed on the tip of the unit.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 not confirmed.The stent delivery system was thoroughly inspected, and no anomalies were observed.The tip of the unit was received properly affixed as expected.It is difficult to draw a clinical conclusion between the device and the events based on the information available as the condition of the returned device does match the description of the complaint.It can be presumed that the device operated as expected since per device analysis, the tip was inspected under the vision system and no anomalies were observed on the tip of the unit.Additionally, the stent of the device was not returned for analysis and therefore no further analysis was performed to determine a potential root cause.Based on the investigation and product analysis conducted, it can be concluded that what the user saw on the tip of the balloon used for post-dilatation was indeed not the complaint products tip as it was received properly affixed as expected to the device as per the product analysis.It is possible that thrombus may have been perceived as the reported catheter tip ¿separated¿ by the user.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.¿ 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.

Manufacturer Narrative

The device was returned and section d10 was updated accordingly.The completed engineering report will be submitted within 30 days upon receipt.

Manufacturer Narrative

The analysis of the device was updated: after a 6mm x 30mm precise pro rapid exchange stent was implanted in the common carotid artery overlapping another stent, the distal tip was not there when the stent delivery system (sds) was removed from the patient.The physician was convinced that it must be on the non-cordis wire, so post-dilation of the stent was done.The distal tip of the sds which was released from the precise stent was on the tip of the balloon used for post-dilatation.The wire with the catheter tip was easily removed from the patient by pulling it out the patient.The intended procedure was carotid artery stenting.The 75% occluded lesion was about 4cm in length in a -6mm~9mm vessel diameter.There was no calcification or vessel tortuosity.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The product was stored, handled, inspected, and prepped according to the instructions for use.There was nothing unusual noted about the stent delivery system prior to use.A 9f sheath introducer and a 9f guiding catheter were used in the procedure.The stent delivery system did not pass through any acute bends.There was no difficulty encountered while advancing/tracking the sds towards the lesion.The user maintained a fixed inner shaft position during deployment.There was no unusual force applied during deployment of the stent.There was no patient injury reported and the procedure was completed.The device was returned for analysis.Previously, a non-sterile pc0930rx precise pro rx us carotid syst stent delivery system was received under this complaint (b)(4) or analysis inside a plastic bag due to a reported catheter tip- separated - in patient.Per visual analysis, the delivery system was observed already actuated/ stent deployed.The valve of the precise pro rx was open.The stent of the unit was not received for analysis.Per catheter tip- separated reported, the device was thoroughly inspected, and the tip was observed in place.No tip separation was observed.Therefore, at that time, the complaint reported by the customer as ¿catheter tip- separated - in patient¿ was not confirmed.Subsequently, the complaint was reopened since it was requested from the affiliate to conduct an additional investigation for (b)(4) returned sample.According to the sales rep, the tip of the device was not torn, but came off easily, and that the physician put the tip back in its original position before handing over the product.Per further analysis, the unit was checked once again to verify whether the tip of the sample can be easily removed.In fact, the tip was pulled /detached from the inner guide wire lumen with little effort.However, a twisted/ torn damage could be observed on the inner guide wire near to the tip separation.Also, the adhesive state between the tip and shaft was verified looking for any issue with the adhesive between the tip and shaft.Per microscopic analysis, the tip was cross-sectioned.Presence of an adhered like adhesive substance was observed inside the tip.Per request, a sem analysis was asked to be performed on the observed twisted/ torn damage on the inner guide wire near to the tip separation.Sem was conducted and results showed that the precise pro rx us carotid syst inner guide wire external surface affected area presented evidence of elongations, and material protruding from the twisted/ torn damage.Additionally, remnants of an adhesive like material adhered to the external surface of the inner guide wire was observed.Per analytical laboratory ftir- infrared spectroscopy (ir) the chemical composition of the dissected precise distal tip separated from the inner guide wire and a sample of dymax adhesive were delivered to the analytical laboratory to verify or discard the presence of adhesive inside the tip.In this analysis, the ftir revealed the presence of adhesive in the inner side of the precise distal tip.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.Based on the observed conditions of the unit and the additional test results, on (b)(6) 2021, it was concluded by the product engineering team that the evidence of elongations and material protruding from the inner guide wire twisted/torn damage suggests that a tensile/twisting overload force event occurred on the inner guide wire near the tip separation.Additionally, the remnants of an adhesive like material adhered to the external surface of the inner guide and the confirmed presence of dymax in the inner side of the precise distal tip reveals that the bonding adhesive material was applied in the tip and inner guidewire.Nonetheless, the cause of the twisted/ torn damage condition on the inner guide wire near to the tip could not be conclusively determined.Neither the catheter tip- separated reported nor the observed damage observed in the inner guide wire separation area does not appear to be manufacturing related.Since the device did not present any obvious indication of manufacturing defect or anomaly that could contribute to the tip separation and /or to the inner guide wire twisted/ torn condition.It is probable that procedural and or handling factors such as vessel characteristics (75% occluded lesion) and the user¿s interaction with the device ( elongations, tensile/twisting overload force, as evident by product analysis ) on the device as received, may have led to the reported event as well as the twisted/torn damage noted on the device, as received.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.¿ neither the phr review 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.Please note the h1 event type was revised to serious injury.

Manufacturer Narrative

Updated with revision of the product analysis: after a 6mm x 30mm precise pro rapid exchange stent was implanted in the common carotid artery overlapping another stent, the distal tip was not there when the stent delivery system (sds) was removed from the patient.The physician was convinced that it must be on the non-cordis wire, so post-dilation of the stent was done.The distal tip of the sds which was released from the precise stent was on the tip of the balloon used for post-dilatation.The wire with the catheter tip was easily removed from the patient by pulling it out the patient.According to the sales rep, the tip of the device was not torn, but came off easily, and that the physician put the tip back in its original position before handing over the product.The intended procedure was carotid artery stenting.The 75% occluded lesion was about 4cm in length in a -6mm~9mm vessel diameter.There was no calcification or vessel tortuosity.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background is clearly visible.The product was stored, handled, inspected, and prepped according to the instructions for use (ifu).There was nothing unusual noted about the stent delivery system prior to use.A 9f sheath introducer and a 9f guiding catheter were used in the procedure.The stent delivery system did not pass through any acute bends.There was no difficulty encountered while advancing/tracking the sds towards the lesion.The user maintained a fixed inner shaft position during deployment.There was no unusual force applied during deployment of the stent.There was no patient injury reported and the procedure was completed.The device was returned for analysis.A non-sterile (b)(4) precise pro rx us carotid stent delivery system (ses) was received for analysis inside a plastic bag due to a reported catheter tip- separated - in patient.Per visual analysis, the delivery system was observed already actuated/ stent deployed.The valve of the precise pro rx was open.The stent of the unit was not received for analysis.Per further analysis, the unit was checked once again to verify whether the tip of the sample can be easily removed.In fact, the tip was pulled /detached from the inner guide wire lumen with little effort.However, a twisted/ torn damage could be observed on the inner guide wire near to the tip separation.Also, the adhesive state between the tip and shaft was verified looking for any issue with the adhesive between the tip and shaft.Per microscopic analysis, the tip was cross-sectioned.Presence of an adhered like adhesive substance was observed inside the tip.A microscopic analysis was performed on the observed twisted/ torn damage on the inner guide wire near to the tip separation.Results showed that the inner guide wire external surface affected area, of the precise pro rx us carotid system, presented evidence of elongations, and material protruding from the twisted/ torn damage.Additionally, remnants of an adhesive like material adhered to the external surface of the inner guide wire was observed.The evidence of elongations and material protruding from the affected twisted/torn damage area suggests that a tensile/twisting overload force event occurred on the inner guide wire near the tip separation.Additionally, the remnants of a material adhered to the surface of the inner guide wire tip suggest the presence of bonding adhesive material applied in the tip and inner guidewire, same that it is to be confirmed or discarded through additional analytical laboratory analysis to be made in the associated detached tip sample involved in the complaint.No other abnormalities were found during the microscopic analysis.Per analytical laboratory ftir- infrared spectroscopy (ir) the chemical composition of the dissected precise distal tip separated from the inner guide wire and a sample of dymax adhesive were delivered to the analytical laboratory to verify or discard the presence of adhesive inside the tip.In this analysis, the ftir revealed the presence of adhesive in the inner side of the precise distal tip.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.The tip was pulled by hand and separated from the inner guide wire lumen with little effort.Due to this tip separation, the adhesive state between the tip and shaft was verified looking for any issue with the adhesive between the tip and shaft.The tip was cross-sectioned and inspected under the vision system.Presence of an adhered like adhesive substance was observed inside the tip.Based on the observed conditions of the unit and the microscopic and analytical test results, it was concluded that evidence of elongations and material protruding from the inner guide wire twisted/torn damage suggests that a tensile/twisting overload force event occurred on the inner guide wire near the tip separation.Additionally, the remnants of an adhesive like material adhered to the external surface of the inner guide and the confirmed presence of dymax in the inner side of the precise distal tip reveals that the bonding adhesive material was applied in the tip and inner guidewire.The cause of the twisted/ torn damaged condition on the inner guide wire near to the tip could not be conclusively determined.It is probable that procedural and or handling factors such as vessel characteristics (75% occluded lesion) and the user¿s forceful interaction with the device as evident by product analysis on the device, as received (elongations, tensile/twisting overload force) may have contributed to the reported event.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.¿ due to the reported event experienced by the customer, a corrective/preventive action will be taken at this time.According to the sales rep, the tip of the device was not torn, but came off easily, and that the physician put the tip back in its original position before handing over the product.

• 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: 10875264
• MDR Text Key: 217463989
• Report Number: 9616099-2020-04076
• 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,Followup,Followup,Followup
• Report Date: 05/21/2021

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: N/A
• Device Catalogue Number: PC0930RXC
• Device Lot Number: 17934632
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/26/2020
• Initial Date FDA Received: 11/20/2020
• Supplement Dates Manufacturer Received: 12/08/2020; 12/27/2020; 02/02/2021; 05/18/2021
• Supplement Dates FDA Received: 12/15/2020; 12/28/2020; 02/04/2021; 05/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EZ WIRE; EZ WIRE