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

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Telephone number is (b)(6).The device was not returned for analysis.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
During the delivery of a precise pro rx us carotid stent to the lesion, it got stuck and could not be removed.However, the physician managed to remove the device from the patient's body.Therefore, it was replaced with a same size unknown new device and the procedure was completed.There was no reported patient injury.This was a carotid artery stenting (cas) case.After pre-dilation with an unknown balloon catheter, the precise pro stent was inserted.The device will not be returned as it was discarded.
Additional Manufacturer Narrative
During the delivery of a precise pro rx us carotid stent to the lesion, it got stuck and could not be removed.However, the physician managed to remove the device from the patient's body.Therefore, it was replaced with a same size unknown new device and the procedure was completed.This was a carotid artery stenting (cas) case.After pre-dilation with an unknown balloon catheter, the precise pro stent was inserted.There was no reported patient injury.The device was not returned for analysis.A product history record (phr) review of lot 17902997 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Without the return of the device for analysis and based on the information provided, the reported ¿stent delivery system (sds)-ses-tracking difficulty¿ and ¿stent delivery system (sds)-ses-withdrawal difficulty - from vessel¿ could not be confirmed and the exact root cause could not be determined.Handling and or procedural factors such as vessel characteristics (although unknown) may have led to the reported events.According to the instructions for use, which is not intended as a mitigation of risk, ¿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.Note: if resistance is met during delivery system introduction, the system should be withdrawn and another system should be used.Note: if any resistance is met during delivery system withdrawal, advance the outer sheath until the outer sheath marker contacts the catheter tip and withdraw the system as one unit.¿ neither the phr review nor the information available suggests a design or manufacturing related cause could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken.

• Brand Name: PRECISE PRO RX US CAROTID SYST
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 10173508
• Report Number: 9616099-2020-03752
• Device Sequence Number: 3513954
• Product Code: NIM
• UDI-Device Identifier: 20705032036495
• UDI-Public: 20705032036495
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2020

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: 09/30/2021
• Device Model Number: N/A
• Device Catalogue Number: PC0840RXC
• Device Lot Number: 17902997
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 07/10/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 07/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNKNOWN.