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

Model Number	N/A
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
As per sales rep, the 5x40mm precise pro rx self expanding stent (ses) was inserted into the patient and prior to deployment it was noticed that under fluoro the tip was flared.An image of the device was provided indicates premature deployment.The procedure was successfully completed with another stent.There was no patient injury.The intended procedure was a carotid stenting.The product was stored, handled, inspected and prepped according to the instructions for use.There was no difficulty during preparation of the device.There was difficulty inserting the ses into the sheath/into the patient because it had a flared tip.There was no excessive force used.An embolic protection device was used in the procedure.The device will be returned for analysis.
Additional Manufacturer Narrative
This device is available for analysis but has not yet been received.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
Please note update to the udi# in section d4.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Please note d9 update regarding product return date.Additional information is pending and will be submitted within 30 days upon receipt.
Additional Manufacturer Narrative
A precise pro rx the 5x40mm self expanding stent (ses) was inserted into the patient and prior to deployment it was noticed that under fluoro the tip was flared.An image of the device was provided which indicates premature deployment.The procedure was successfully completed with another stent.The intended procedure was a carotid stenting.The product was stored, handled, inspected and prepped according to the instructions for use (ifu).There was no difficulty during preparation of the device.There was difficulty inserting the ses into the sheath/into the patient because it had a flared tip.There was no excessive force used.An embolic protection device was used in the procedure.There was no patient injury.The device was retuned for analysis.One non-sterile precise pro rx us carotid syst self expanding stent system was received for analysis inside a plastic bag.The valve of the precise pro rx was received tighten / closed.Per visual analysis, the stent of the unit was received 1.0 mm premature deployed.Also, the body shaft of the unit was received accordioned- like.Besides the previous mentioned conditions, no obvious defects or anomalies were found that could had contributed to the reported event.Per functional analysis, a deployment test was performed on the unit.The tuohy borst valve of the stent delivery system was opened, and the stent deployment test was successfully performed by retracting the outer sheath while holding the inner shaft in a fixed position.The stent was fully unsheathed/expanded as expected.No anomalies found.Per dimensional analysis, the usable length of the unit was measured, and it was found within specification.A product history record (phr) review of lot 18058440 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/in patient - during advancement¿ was confirmed since the stent of the unit was received for analysis 1.0 cm pre deployed.However, the exact cause of the self-expanding stent system pre deployed condition could not be conclusively determined during the analysis.It can be suggested that procedural factors and/ or handling process may have contributed to the stent pre deployment condition of the unit the way it was received for evaluation.Analysis results and phr review results do not suggest that the observed pre-deployment condition is related to the manufacturing process.However, as stated by the customer ¿there was difficulty inserting the ses into the sheath/into the patient because it had a flared tip.¿ according to the instructions for use (ifu), ¿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.If a gap between the catheter tip and outer sheath tip exists, open the tuohy borst valve and gently pull the inner shaft in a proximal direction until the gap is closed.Lock the tuohy borst valve after the adjustment by rotating the proximal valve end in a clockwise direction.¿ neither the phr review nor the product analysis suggests that the reported events could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

• Brand Name: PRECISE PRO RX US CAROTID SYST
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): CORDIS CASHEL; cahir road; cashel E25 R C92; EI E25 RC92
• Manufacturer (Section G): CORDIS CASHEL; cahir road; cashel E25 R C92; EI E25 RC92
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13618111
• Report Number: 9616099-2022-05379
• Device Sequence Number: 17125231
• Product Code: NIM
• UDI-Device Identifier: 20705032036402
• UDI-Public: (01)20705032036402(17)230930(10)18058440
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P030047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/07/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: PC0540RXC
• Device Lot Number: 18058440
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/03/2022
• Supplement Date Received by Manufacturer: 02/28/2022; 04/05/2022
• Initial Report FDA Received Date: 02/28/2022
• Supplement Report FDA Received Date: 03/22/2022; 04/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.
• Patient Age: 70 YR
• Patient Sex: Female
• Patient Weight: 75 KG