MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 5X30; STENT, CAROTID

Catalog Number PC0530XCE

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/29/2020

Event Type  malfunction  

Manufacturer Narrative

After an angiographic shoot, the physician decided to use a precise pro 5mm x 30mm rx self-expanding stent (ses), however, while flushing from the side port with the saline the y connector tightened, and the stent deployed on the preparation table.Therefore, the procedure was completed with the use of the same precise pro stent but with the size of 5mm x 20mm.The device was prepped in the tray, stored, handled and prep according to the ifu.There was no unusual noted about the stent delivery system prior to use.The precise pro rx package was not in open position.The tuohy borst hemostatic valve was in open position when received and was closed prior to removing the device from the tray.When removed from the tray, the stent was still constrained within the outer member or sheath.The stopcock was connected to the y-connector of the tuohy borst valve.There was no difficulty encountered flushing the stopcock.There was no difficulty encountered flushing the precise pro rx ses device.There was no reported patient injury.The product was returned for analysis.One non-sterile precise pro rx 5mm x 30mm stent delivery system unit was received for analysis inside a plastic bag.Per visual analysis, the stent of the unit was observed already deployed and the stent was not returned.The valve of the unit was received unlocked/ opened.No anomalies found.Per functional analysis, deployment was not performed due to the already actuated condition of the stent delivery system unit.Per dimensional analysis, usable length of the unit was found within specification.A product history record (phr) review of lot 17857351 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 due to the conditions of the unit.The cause of the reported event could not be conclusively determined during the analysis.Handling factors such as improper preparation of unit by operator may have led to the reported event.According to the instructions for use ¿carefully inspect the sterile package and device prior to use.Do not use if it appears damaged.If resistance is encountered at any time during the insertion procedure, do not force passage.Resistance may cause damage to stent or lumen.Use a 3-10 cc syringe to flush the inner lumen of the guidewire tube with sterile heparinized saline through the proximal luer hub (6) attached to the pusher tube until saline flows out of the guidewire lumen at the distal tip.Warning: if the inner lumen of the guidewire tube cannot be flushed do not use the device.Introduce the stent delivery system.Advance the device over the guidewire and through the introducer to the target site.If resistance is met during delivery system introduction, the system should be withdrawn and another system used.¿neither the phr review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.

Event Description

After an angiographic shoot, the physician decided to use a 5mm x 30mm precise pro rx self-expanding stent (ses), however, while flushing from the side port with the saline the y connector tightened, and the stent deployed on the preparation table.Therefore, the procedure was completed with the use of the same precise pro stent but with the size of 5mm x 20mm.The device was prepped in the tray, stored, handled and prep according to the ifu.There was no unusual noted about the stent delivery system prior to use.The precise pro rx package was not in open position.The tuohy borst hemostatic valve was in open position when received and was closed prior to removing the device from the tray.When removed from the tray, the stent was still constrained within the outer member or sheath.The stopcock was connected to the y-connector of the tuohy borst valve.There was no difficulty encountered flushing the stopcock.There was no difficulty encountered flushing the precise pro rx ses device.There was no reported patient injury.The device is expected to be returned for evaluation.

• Brand Name: PRECISE PRO RX 5X30
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 9902800
• MDR Text Key: 200040274
• Report Number: 9616099-2020-03610
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: PC0530XCE
• Device Lot Number: 17857351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2020
• Date Manufacturer Received: 03/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2019
• 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
• Patient Age: 59 YR
• Patient Weight: 64