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

Model Number N/A

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/13/2018

Event Type  malfunction  

Manufacturer Narrative

Manufacturing telephone and fax numbers of cordis cashel are respectively, (b)(4).During an unknown procedure.An 8x30 precise pro rx us carotid system did not cross the lesion.There was no patient injury.No other information was reported.The device was returned for analysis.A non-sterile precise pro rx us carotid system was received for analysis.Per visual inspection, the stent was partially deployed.No other damages or anomalies were detected.Per dimensional analysis, the outer diameter (od) measurements were taken at three different places and were found within specification.Functional test could not be performed due to the nature of the event.A product history record (phr) review of lot 17656553 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The phr review does not suggest that the event reported by the customer could be related to the manufacturing process.The event reported by the customer as ¿stent delivery system - failure to cross" could not be confirmed due to the nature of the event and the relationship to the device.The dimensional analysis results were found within specification.Analysis of the returned device indicated the stent was partially deployed.The event identified by fal analysis as ¿stent delivery system (sds)-ses deployment difficulty - premature deployment¿ was determined via visual analysis.Per the instructions for use, which is not intended as a mitigation, ¿if resistance is met during delivery system introduction, the system should be withdrawn, and another system should be used.If any resistance is met during delivery system withdrawal, advance the outer sheath until the marker contacts the catheter tip and withdraw the system as one unit.The exact cause of the events could not be conclusive determined.However, procedural and handling factors such as the application of excessive force, as well as vessel characteristics, while unknown, may have contributed to the reported events.Per the instructions for use, which is not intended as a mitigation, ¿precise® pro rx nitinol stent system is shipped with the tuohy borst valve in the open position.Care should be taken not to pre-deploy the stent.The device should be prepped in the tray.After prep, 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 product analysis nor the phr review suggests that the event could be related to the manufacturing process; therefore, no corrective action will be taken at this time.

Event Description

An 8x30 precise rx self expanding stent did not.Cross the lesion.There was no patient injury.Analysis of the returned device indicated the stent was partially deployed.

• Brand Name: PRECISE PRO RX US CAROTID SYST
• Type of Device: SELF EXPANDABLE STENT
• Manufacturer (Section D): CORDIS CASHEL; cahir road; co. tipperary; cashel ; EI
• Manufacturer (Section G): CORDIS CASEHEL; cahir road; co. tipperary; cashel ; EI
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 7973237
• MDR Text Key: 123946319
• Report Number: 9616099-2018-02447
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036488
• UDI-Public: 20705032036488
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2018

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: 02/28/2019
• Device Model Number: N/A
• Device Catalogue Number: PC0830RXC
• Device Lot Number: 17656553
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Initial Date Manufacturer Received: 10/04/2018
• Initial Date FDA Received: 10/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2017
• 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