MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 8X40; STENT, CAROTID

Model Number PC0840XCE

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 10/14/2022

Event Type  malfunction  

Manufacturer Narrative

Patient height: 165cm.A review of the manufacturing documentation associated with lot 18105599 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, when the precise pro rx 8x40 stent was 1/5th deployed before the device was removed from the tray.An attempt was made to retrieve it into the release sheath, but it failed.The case was completed with the use of anew precise device.There was no reported injury to the patient.The product was stored and handled according to the ifu.There were no damages noted to the packaging of the device prior to use.There was nothing unusual noted about the stent delivery system prior to use.The temperature exposure indicator on the pouch was checked and confirmed that the black dotted pattern with a grey background is clearly visible.The device was prepped while in the tray.The stent was still constrained within the outer member/sheath when the device was removed from the tray.The tuohy borst (hemostasis) valve was in the open position when received.The tuohy borst valve was closed prior to removing the device from the tray.A stopcock was connected to the y-connector of the tuohy borst valve.There was no difficulty noted while flushing the stopcock.The device will be returned for evaluation.

Manufacturer Narrative

The precise pro rx 8x40 stent was 1/5th deployed before the device was removed from the tray.An attempt was made to retrieve it into the release sheath, but it failed.The case was completed with the use of a new precise device.There was no reported injury to the patient.The product was stored and handled according to the ifu (instructions for use).There were no damages noted to the packaging of the device prior to use.There was nothing unusual noted about the stent delivery system prior to use.The temperature exposure indicator on the pouch was checked and confirmed that the black dotted pattern with a grey background is clearly visible.The device was prepped while in the tray.The stent was still constrained within the outer member/sheath when the device was removed from the tray.The tuohy borst (hemostasis) valve was in the open position when received.The tuohy borst valve was closed prior to removing the device from the tray.A stopcock was connected to the y-connector of the tuohy borst valve.There was no difficulty noted while flushing the stopcock.The product was returned for analysis.A non-sterile unit of precise pro rx 8x40 stent delivery system was received for analysis coiled inside of a clear plastic bag.Per visual analysist two kinks located approximately at 262 and 102 cm from the proximal end were noted.The stent is fully deployed and was returned for analysis.The stent does not present any damages or anomalies and it is expanded as expected.The hemostasis valve was returned tight closed.No other outstanding details were noted.Dimensional analysis was not performed due to the severe kinked condition of the returned unit.Functional analysis was not performed as the unit was returned fully deployed and with severe kinks.However, the deploying mechanism was actuated manually finding no anomalies.A product history record (phr) review of lot 18105599 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 not confirmed through analysis of the returned device as the unit was returned fully deployed.The exact cause of the event could not be determined during analysis.Based on the information available for review, shipping or handling factors may have contributed to the 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.¿ 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, when the precise pro rx 8x40 stent was 1/5th deployed before the device was removed from the tray.An attempt was made to retrieve it into the release sheath, but it failed.The case was completed with the use of anew precise device.There was no reported injury to the patient.The product was stored and handled according to the ifu.There were no damages noted to the packaging of the device prior to use.There was nothing unusual noted about the stent delivery system prior to use.The temperature exposure indicator on the pouch was checked and confirmed that the black dotted pattern with a grey background is clearly visible.The device was prepped while in the tray.The stent was still constrained within the outer member/sheath when the device was removed from the tray.The tuohy borst (hemostasis) valve was in the open position when received.The tuohy borst valve was closed prior to removing the device from the tray.A stopcock was connected to the y-connector of the tuohy borst valve.There was no difficulty noted while flushing the stopcock.The device will be returned for evaluation.

• Brand Name: PRECISE PRO RX 8X40
• 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: 15764186
• MDR Text Key: 304805883
• Report Number: 9616099-2022-06091
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032062425
• UDI-Public: (01)20705032062425(17)240331(10)18105599
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• 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
• Report Date: 11/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2024
• Device Model Number: PC0840XCE
• Device Catalogue Number: PC0840XCE
• Device Lot Number: 18105599
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/24/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: PRECISE STENT DEVICE.; UNK SHEATH.
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 62 KG