MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 6X40; STENT, CAROTID

Model Number PC0640XCE

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 01/25/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18018415 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the stent of a precise pro rx 6x40 was released in advance due to mis-operation by assistant during the preparation of device.There was no reported injury to the patient.The device was prepper per the instruction for use (ifu) and was prepped while in the tray.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible.The product was stored and handled according to the ifu.There was nothing unusual noted about the stent delivery system prior to use.The tuohy borst (hemostasis) valve was in the open position when received.It was also noted that the tuohy borst valve was open while the device was being removed from the tray.The stent was constrained within the outer member/sheath when the device was removed from the tray.The case was completed with the use of a new precise system.The device will be returned for evaluation.

Manufacturer Narrative

The stent of a precise pro rx 6x40 was released in advance due to missed operation by assistant during the preparation of device.The device was prepper per the instruction for use (ifu) and was prepped while in the tray.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible.The product was stored and handled according to the ifu.There was nothing unusual noted about the stent delivery system prior to use.The tuohy borst (hemostasis) valve was in the open position when received.It was also noted that the tuohy borst valve was open while the device was being removed from the tray.The stent was constrained within the outer member/sheath when the device was removed from the tray.The case was completed with the use of a new precise system.There was no reported injury to the patient.The device was not returned for analysis.A product history record (phr) review of lot 18018415 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device for analysis the reported ¿stent delivery system (sds)-ses~ deployment difficulty - premature/during prep¿ was not confirmed.Per the investigation conducted, the end user stated that ¿it was also noted that the tuohy borst valve was open while the device was being removed from the tray.¿ according to the instructions for use (ifu) ¿preparation of stent delivery system: caution: the stent delivery system is shipped with the tuohy borst valve open.Be careful not to prematurely deploy the stent during preparation.Prep the device in the tray per instructions below.Close the tuohy borst valve prior to removing the device from the tray.¿ handling factors such as the user¿s interaction with the device during prep (not closing the tuohy borst valve prior to removal from tray) led to the reported event.Neither the phr review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

Event Description

As reported, the stent of a precise pro rx 6x40 was released in advance due to mis-operation by assistant during the preparation of device.There was no reported injury to the patient.The device was prepper per the instruction for use (ifu) and was prepped while in the tray.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible.The product was stored and handled according to the ifu.There was nothing unusual noted about the stent delivery system prior to use.The tuohy borst (hemostasis) valve was in the open position when received.It was also noted that the tuohy borst valve was open while the device was being removed from the tray.The stent was constrained within the outer member/sheath when the device was removed from the tray.The case was completed with the use of a new precise system.The device will not be returned for evaluation after multiple attempts were made without success.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: the stent of a precise pro rx 6x40 was released in advance due to mis-operation by assistant during the preparation of device.There was no reported injury to the patient.The device was prepped per the instruction for use (ifu) and was prepped while in the tray.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible.The product was stored and handled according to the ifu.There was nothing unusual noted about the stent delivery system prior to use.The tuohy borst (hemostasis) valve was in the open position when received.It was also noted that the tuohy borst valve was open while the device was being removed from the tray.The stent was constrained within the outer member/sheath when the device was removed from the tray.The case was completed with the use of a new precise system.The product was returned for analysis.A non-sterile unit of precise pro rx 6x40 was received for analysis coiled inside of a clear plastic bag.Per visual analysis a severe kinked/bent condition was identified located approximately 26 cm from the distal tip.The stent is partially deployed.The hemostasis valve was loose.No other damages or anomalies were observed.Per dimensional analysis the device was found to be within specification.Per functional analysis the stent deployment test was initiated by retracting the outer sheath while holding the inner shaft in a fixed position.But the push rod did not travel toward the distal tip as expected and the stent was not able to be deployed.A product history record (phr) review of lot 18018415 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿stent delivery system (sds)-ses deployment difficulty - premature/during prep¿ was confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.Based on the information available for review, procedural and/or handling factors may have contributed to the event as evidenced by the kink noted during analysis.However this may also have occurred during the return of the device as it is not noted in the event description.It is noted that this event was caused by mishandling by the operator¿s assistant during preparation of the device.According to the instructions for use, which is not intended as a mitigation of risk, ¿preparation of stent delivery system caution: the stent delivery system is shipped with the tuohy borst valve open.Be careful not to prematurely deploy the stent during preparation.Prep the device in the tray per instructions below.Close the tuohy borst valve prior to removing the device from the tray.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.¿ neither the phr review nor the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

Event Description

As reported, the stent of a precise pro rx 6x40 was released in advance due to mis-operation by assistant during the preparation of device.There was no reported injury to the patient.The device was prepper per the instruction for use (ifu) and was prepped while in the tray.The temperature exposure indicator on the pouch was checked to confirm that the black dotted pattern with a grey background was clearly visible.The product was stored and handled according to the ifu.There was nothing unusual noted about the stent delivery system prior to use.The tuohy borst (hemostasis) valve was in the open position when received.It was also noted that the tuohy borst valve was open while the device was being removed from the tray.The stent was constrained within the outer member/sheath when the device was removed from the tray.The case was completed with the use of a new precise system.The device will be returned for evaluation.

• Brand Name: PRECISE PRO RX 6X40
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 14013179
• MDR Text Key: 292841871
• Report Number: 9616099-2022-05519
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032062384
• UDI-Public: (01)20705032062384(17)220331(10)18018415
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2022

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: 03/31/2023
• Device Model Number: PC0640XCE
• Device Catalogue Number: PC0640XCE
• Device Lot Number: 18018415
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2022
• Initial Date FDA Received: 04/05/2022
• Supplement Dates Manufacturer Received: 04/15/2022; 07/11/2022
• Supplement Dates FDA Received: 04/22/2022; 08/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NEW PRECISE STENT.
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 63 KG