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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS US CORP. PRECISE PRO RX; STENT, CAROTID

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CORDIS US CORP. PRECISE PRO RX; STENT, CAROTID Back to Search Results
Catalog Number PC0740RXC
Device Problem Difficult or Delayed Positioning (1157)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/29/2023
Event Type  malfunction  
Manufacturer Narrative
A precise pro rx carotid self-expanding stent could not be used to do a carotid artery stenting (cas) because it could not cross the blood vessel and was bent.The device was received for evaluation and was partially deployed.It was further confirmed that the partially deployed condition occurred during use in the patient.Multiple attempts to gather additional information have been made and have been unsuccessful.There was no reported patient injury.The device was returned for analysis.A non-sterile unit of ¿precise pro rx us carotid system¿ was received for analysis coiled inside of a clear plastic bag.The device was unpacked and was placed at one metallic tray to be inspected.A thorough inspection was performed on the unit observing two kinks located approximately at 9 and 82 cm from the distal tip.Also, the hypotube presents a kinked condition located approximately at 7 from the proximal end.The device is partially deployed.The hemostasis valve was returned open.No other outstanding details were noticed.Dimensional analysis was performed to verify the correct outer diameter of the stent crossing profile.Measurements were taken at two different places and results were found within specification.Functional test was not performed due to the nature of the complaint; the reported malfunction is not possible to reproduce in a laboratory environment.A product history record (phr) review of lot 18177086 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)-failure to cross¿ could not be confirmed due to the nature of the complaint and due to the outer diameter of the stent crossing profile was found within specification.However, according with the evaluation outcomes the ¿stent delivery system (sds)~kinked/bent¿ was confirmed.Also, a partial stent deployment was observed.The exact cause of the observed damages could not be conclusively determined during the analysis.Procedural and/or handling factors might have contributed to this issue.According to the instructions for use (ifu) ¿if resistance is encountered at any time during the insertion procedure, do not force passage.Resistance may cause damage to stent or system.If resistance occurs during movement through the sheath, carefully withdraw the stent system.Once stent deployment has begun, the stent must be fully deployed.The system is not designed for stent repositioning or recapturing.If resistance is felt when initially retracting the outer deployment sheath do not force deployment.Carefully withdraw the stent system without deploying the stent.¿ the product analysis does not suggest that the found damages could be related to the manufacturing process of the unit.Therefore, no corrective or preventive actions will be taken at this time.
 
Event Description
As reported, a precise pro rx carotid self-expanding stent could not be used to do a carotid artery stenting (cas) because it could not cross the blood vessel and was bent.There was no reported patient injury.The device was received for evaluation and was partially deployed.It was further confirmed that the partially deployed condition occurred during use in the patient.Multiple attempts to gather additional information have been made and have been unsuccessful.
 
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Brand Name
PRECISE PRO RX
Type of Device
STENT, CAROTID
Manufacturer (Section D)
CORDIS US CORP.
14201 nw 60th avenue
miami lakes, florida 33014
Manufacturer (Section G)
CORDIS US CORP.
14201 nw 60th avenue
miami lakes, florida 33014
Manufacturer Contact
karla castro
santiago troncoso 808
juarez, chihuahua 32574
MX   32574
7863138372
MDR Report Key18155050
MDR Text Key328420472
Report Number9616099-2023-06637
Device Sequence Number1
Product Code NIM
UDI-Device Identifier20705032036464
UDI-Public20705032036464
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
P030047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 11/16/2023
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 Catalogue NumberPC0740RXC
Device Lot Number18177086
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/02/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 11/08/2023
Initial Date FDA Received11/16/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/16/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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