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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS DE MEXICO PRECISE PRO RX 9X40; STENT, CAROTID

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CORDIS DE MEXICO PRECISE PRO RX 9X40; STENT, CAROTID Back to Search Results
Model Number PC0940XCE
Device Problem Detachment Of Device Component (1104)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/03/2017
Event Type  malfunction  
Manufacturer Narrative
The delivery shaft of the precise pro rx 9 x 40 was fractured during use.There was no reported patient injury.The product was stored and handled according to the instructions for use (ifu).There was no damage noted to the packaging of the devices.The device was stored in the lab according to ifu.The product was stored for one day before it was distributed to the cath lab.There was no damage to the device noticed prior to opening the package.There was no difficulty removing the device from the sterile packaging.The delivery shaft crack was noted before the delivery shaft was used in the patient.The device was in more than one piece.The procedure was completed successfully with another product to complete the procedure.The product was returned for analysis.One non-sterile unit of a precise pro rx 9x40 stent delivery system (sds) was returned.Per visual analysis, the outer member of the unit was separated at 19.8 cm from the distal end.The stent was inside the unit and not deployed.Dried blood residues were noted on the tip of the unit.No other anomalies were noted.Stroke length (pin-pull sds) dimensional analysis was not performed as the outer member was separated.Functional analysis could not be performed as the outer member was separated.Per microscopic analysis the separated sections of outer member revealed elongations and frayed edges.These characteristics are clear evidence of an application of a tension force that induced the separation.No other issues were noted during microscopic analysis.A device history record (dhr) review of lot 17610396 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-separated - during prep¿ was confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.Based on the information available for review, procedural or handling factors may have contributed to the separation as evidenced by elongations and frayed edges noted on the outer member during analysis which are indicative of excessive force being applied to the device.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 at this time.
 
Event Description
As reported, the delivery shaft of the precise pro rx 9 x 40 was fractured during use.There was no reported patient injury.The product and will be returned for analysis.The product was stored and handled according to the instructions for use (ifu).There was no damage noted to the packaging of the devices.The device was stored in the lab according to ifu.The product was stored for one day before it is distributed to the cath lab.There was no damage to the device noticed prior to opening the package.There was no difficulty removing the device from the sterile packaging.The delivery shaft crack was noted before the delivery shaft was used in the patient.The device was in more than one piece.The procedure was completed successfully with another product to complete the procedure.
 
Manufacturer Narrative
The sections have been updated accordingly.The delivery shaft of the precise pro rx 9 x 40 was fractured in the patient.There was no reported patient injury.The product was stored and handled according to the instructions for use (ifu).There was no damage noted to the packaging of the devices.The device was stored in the lab according to ifu.The product was stored for one day before it was distributed to the cath lab.There was no damage to the device noticed prior to opening the package.There was no difficulty removing the device from the sterile packaging.The device was in more than one piece.The procedure was completed successfully with another product to complete the procedure.The product was returned for analysis.One non-sterile unit of a precise pro rx 9x40 stent delivery system (sds) was returned.Per visual analysis, the outer member of the unit was separated at 19.8 cm from the distal end.The stent was inside the unit and not deployed.Dried blood residues were noted on the tip of the unit.No other anomalies were noted.Stroke length (pin-pull sds) dimensional analysis was not performed as the outer member was separated.Functional analysis could not be performed as the outer member was separated.Per microscopic analysis the separated sections of outer member revealed elongations and frayed edges.These characteristics are clear evidence of an application of a tension force that induced the separation.No other issues were noted during microscopic analysis.A device history record (dhr) review of lot 17610396 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-separated - during prep¿ was confirmed through analysis of the returned device.The exact cause of the event could not be determined during analysis.Based on the information available for review, procedural or handling factors may have contributed to the separation as evidenced by elongations and frayed edges noted on the outer member during analysis which are indicative of excessive force being applied to the device.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 at this time.
 
Event Description
As reported, the delivery shaft of the precise pro rx 9 x 40 was fractured in the patient.There was no reported patient injury.The product and will be returned for analysis.The product was stored and handled according to the instructions for use (ifu).There was no damage noted to the packaging of the devices.The device was stored in the lab according to ifu.The product was stored for one day before it is distributed to the cath lab.There was no damage to the device noticed prior to opening the package.There was no difficulty removing the device from the sterile packaging.The device was in more than one piece.The procedure was completed successfully with another product to complete the procedure.
 
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Brand Name
PRECISE PRO RX 9X40
Type of Device
STENT, CAROTID
Manufacturer (Section D)
CORDIS DE MEXICO
circuito int nte 1820
juarez 32575
MX  32575
Manufacturer (Section G)
CORDIS DE MEXICO
circuito int nte 1820
juarez 32575
MX   32575
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
MDR Report Key6605210
MDR Text Key76450326
Report Number9616099-2017-01136
Device Sequence Number1
Product Code NIM
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 08/23/2017
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 Date09/30/2018
Device Model NumberPC0940XCE
Device Catalogue NumberPC0940XCE
Device Lot Number17610396
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/12/2017
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date05/08/2017
Initial Date Manufacturer Received 05/08/2017
Initial Date FDA Received06/01/2017
Supplement Dates Manufacturer Received07/31/2017
Supplement Dates FDA Received08/23/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/24/2016
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
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