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

Model Number PC1040RXC

Device Problem Difficult or Delayed Positioning (1157)

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

Event Date 08/17/2022

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18068566 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.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, while attempting to deploy a 10mm x 40mm precise pro rx carotid self-expanding stent (ses) delivery system, the inner cylinder was fixed, and the outer member was retracted.However, the stent was unable to de deployed.Excess force was used to further retract the outer member and only the distal tip of the stent was able to be deployed.There was no reported injury to the patient.Additional information was requested but was not provided.The device will be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: while attempting to deploy a 10mm x 40mm precise pro rx carotid self-expanding stent (ses) delivery system, the inner cylinder was fixed, and the outer member was retracted.However, the stent was unable to de deployed.Excess force was used to further retract the outer member and only the distal tip of the stent was able to be deployed.There was no reported injury to the patient.Additional information was requested but was not provided.The product was returned for analysis.One non-sterile precise pro rx us carotid system stent delivery system was received for analysis inside a plastic bag.No original packaging was returned.The valve of the unit was received closed.Per visual analysis, the stent of the unit was observed not deployed.No visible anomalies were observed.Per dimensional analysis, the stroke length of the stent delivery system was measured, and the results were found within specification.Per functional analysis a deployment test was performed, and no difficulty or anomaly was noted during the test.A product history record (phr) review of lot 18068566 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 - partial deployment¿ was not confirmed by analysis of the returned device.The exact cause of the reported event could not be confirmed.According to the instructions for use which is not intended as a mitigation of risk ¿slack removal a.Advance the stent delivery system past the lesion site.B.Pull back the stent delivery system until the radiopaque inner shaft markers (leading and trailing ends) move in position so that they are proximal and distal to the target lesion.C.Ensure the device outside the patient remains flat and straight.Caution: slack in the catheter shaft either outside or inside the patient may result in deploying the stent beyond the lesion site.5.Stent deployment.Note: when ready to proceed with stent deployment, heparin may be administered per standard hospital practice or as prescribed by a physician.Heparin may be continued following stent deployment if so indicated by a physician or hospital protocol.A.Verify that the delivery system's radiopaque inner shaft markers (leading and trailing ends) are proximal and distal to the target lesion.B.Unlock the tuohy borst valve connecting the inner shaft and outer sheath of the delivery system.C.Ensure that the access sheath or guiding catheter does not move during deployment.D.Initiate stent deployment by retracting the outer sheath while holding the inner shaft in a fixed position.Deployment is complete when the outer sheath marker passes the proximal inner shaft stent marker.Note: the mechanism for stent deployment is outer sheath retraction.Deployment is completed by maintaining inner shaft position while retracting the outer sheath and allowing the stent to expand.¿ the device performed as intended and therefore could not be related to the manufacturing process; therefore, no 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
• 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: 15407117
• MDR Text Key: 299763130
• Report Number: 9616099-2022-05965
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036556
• UDI-Public: (01)20705032036556(17)231031(10)18068566
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030047
• 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: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: PC1040RXC
• Device Catalogue Number: PC1040RXC
• Device Lot Number: 18068566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2021
• 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
• Patient Outcome(s): Other