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U.S. Department of Health and Human Services

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

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CORDIS CORPORATION PRECISE PRO RX US CAROTID SYST; STENT, CAROTID Back to Search Results
Model Number PC0940RXC
Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/16/2018
Event Type  malfunction  
Manufacturer Narrative
The product was not returned for analysis.Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This device was received for analysis but the engineering report is not yet available.Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
During use, the distal tip of the precise pro stent was caught on a catheter and then it separated.There was no patient injury.The separated distal tip was on the guidewire, therefore, it was removed from the patient.The procedure completed successfully.A precise pro was delivered to the lesion and implanted.When the delivery system was removed, the distal tip got caught by the exit port of a support non cordis catheter.The physician pulled it with some force, then the distal tip separated.The target lesion was unknown.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.The product was clinically used and will be returned for analysis.
 
Manufacturer Narrative
During use, the distal tip of a precise pro rx stent was caught on a catheter and then it separated.There was no patient injury.The separated distal tip was on the guidewire, therefore, it was removed from the patient.The procedure completed successfully.A precise pro rx was delivered to the lesion and implanted.When the delivery system was removed, the distal tip got caught by the exit port of a support non-cordis catheter.The physician pulled it with some force, then the distal tip separated.The target lesion was unknown.The patient¿s vessel level of tortuousness and calcification was unknown.The rate of stenosis was unknown.There were no damages noted to the device packaging.There was no difficulty removing the device from the packaging.No other information was provided.A non-sterile unit precise pro rx us carotid system was received coiled inside of a plastic bag.Per visual analysis a separated condition was found on catheter tip, the catheter tip was not received.The unit was received fully deployed as the stent was also not received.Dried blood residuals were found on the support member.No other damages or anomalies were found on the received unit.Sem results showed that the inner member separation presented material deformation and evidence of elongations.The elongations observed suggest that the device was induced to stretching/pulling events that exceed the material yield strength prior to the separation.A review of the manufacturing documentation, nonconformance records, and excursions associated with lot 17695883 was performed and it was found that no defective units were rejected during the final assembly of this lot.No other incidents were noted that could be potentially related to the complaint reported.The complaint reported by the customer as ¿catheter tip- separated - in patient¿ was confirmed due to the condition of the received unit for analysis.As noted, sem results showed that the inner member separated presented material deformation and evidence of elongations.The elongations observed suggest that the device was induced to stretching/pulling events that exceed the material yield strength prior to the separation.The exact cause of the failure experienced by the customer as well as the damages observed on the unit during the analysis could not be conclusively determined.Procedural factors and handling process may have contributed to the issue reported, as noted by the event that force was used.The complaint reported by the customer as ¿stent delivery system (sds)-ses- withdrawal difficulty - through guide/sheath¿ could not be evaluated due to that the functional test was not performed due to the condition as was received the unit for analysis.The exact cause of the failures reported by the customer could not be conclusively determined.According to the instructions for use ¿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 dhr 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.
 
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Brand Name
PRECISE PRO RX US CAROTID SYST
Type of Device
STENT, CAROTID
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th avenue
miami lakes FL 33014
MDR Report Key7273427
MDR Text Key100436467
Report Number9616099-2018-01882
Device Sequence Number1
Product Code NIM
UDI-Device Identifier20705032036525
UDI-Public20705032036525
Combination Product (y/n)N
PMA/PMN Number
P030047
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/16/2018
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 Date06/30/2019
Device Model NumberPC0940RXC
Device Catalogue NumberPC0940RXC
Device Lot Number17695883
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2018
Distributor Facility Aware Date01/18/2018
Initial Date Manufacturer Received 01/18/2018
Initial Date FDA Received02/15/2018
Supplement Dates Manufacturer Received02/15/2018
Supplement Dates FDA Received03/16/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SUPPORT CATHETER (MOMA, MEDTRONIC)
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