MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE PRO RX 7X30; STENT, CAROTID

Model Number	PC0730XCE
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18088027 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 or Problem Description
As reported, part of a precise pro rx 7x30 self-expanding stent (ses) had been released before it was taken out from the tray.The user tried to use the release sheath to tighten it, but it was unsuccessful.The procedure was completed with another unknown stent.There was no reported patient injury.The malfunction occurred during prep.There was no damage noted to the product packaging upon inspection prior to use.There was no difficulty removing the product from the packaging.The device was stored and prepped per the instructions for use (ifu).The device was opened in a sterile field.The user is trained to the device.The device will be returned for evaluation.
Additional Manufacturer Narrative
-after further review of additional information received the following sections have been updated accordingly: d8, d9, g3, g6, h1, h2, h3, h6, and h10 part of a precise pro rx 7x30 self-expanding stent (ses) had been released before it was taken out from the tray.The user tried to use the release sheath to tighten it, but it was unsuccessful.The procedure was completed with another unknown stent.There was no reported patient injury.The malfunction occurred during prep.There was no damage noted to the product packaging upon inspection prior to use.There was no difficulty removing the product from the packaging.The device was stored and prepped per the instructions for use (ifu).The device was opened in a sterile field.The user is trained to the device.The product was returned for analysis.One non-sterile precise pro rx 7x30mm self-expanding stent (ses) delivery system was received for analysis inside a plastic bag.Neither the mentioned tray nor the original product packaging was returned for evaluation.Per visual analysis the valve of the unit was received partially open (not tightened) and the stent of the unit was received 5mm partially deployed.No other anomalies observed.Per dimensional analysis, the usable length of the stent delivery system was found within specification.Per functional analysis the tuohy borst valve of the stent delivery system was fully opened (loosen), 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.A product history record (phr) review of lot 18088027 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 confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.Unknown factors might have contributed to the observed stent partial deployment since, per as event reported, quote: ¿there was no damage noted to the product packaging upon inspection prior to use.There was no difficulty removing the product from the packaging.¿ according to the instructions for use, which are not intended as a mitigation of risk, ¿preparation of stent delivery system caution: the stent delivery system is shipped with the tuohy borst valve open.Be careful not to prematurely deploy the stent during preparation.Prep the device in the tray per instructions below.Close the tuohy borst valve prior to removing the device from the tray.A.Open the outer box to reveal the pouch containing the stent and delivery system.B.Check the temperature exposure indicator on the pouch to confirm that the black dotted pattern with a grey background is clearly visible.See warnings section.C.After careful inspection of the pouch looking for damage to the sterile barrier, carefully peel open the pouch and remove the tray.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.D.While in the tray, attach a stopcock to the y connection on the tuohy borst valve.E.Attach a 5-cc syringe filled with heparinized saline to the open stopcock and apply positive pressure until saline weeps from the proximal end of the tuohy borst valve.Lock the tuohy borst valve.F.Close the stopcock attached to the tuohy borst y connection.G.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 event experienced by the customer could be related to the manufacturing process; therefore, no corrective/preventive action will be taken at this time.

• Brand Name: PRECISE PRO RX 7X30
• Common Device Name: 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: 15950726
• Report Number: 9616099-2022-06145
• Device Sequence Number: 15093503
• Product Code: NIM
• UDI-Device Identifier: 20705032062388
• UDI-Public: (01)20705032062388(17)240131(10)18088027
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2022

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: 01/31/2024
• Device Model Number: PC0730XCE
• Device Catalogue Number: PC0730XCE
• Device Lot Number: 18088027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2022
• Supplement Date Received by Manufacturer: 12/08/2022
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 12/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2022
• 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: UNKNOWN STENT
• Patient Sex: Unknown