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

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.

• 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 Key: 6605210
• MDR Text Key: 76450326
• Report Number: 9616099-2017-01136
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• 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 Date: 09/30/2018
• Device Model Number: PC0940XCE
• Device Catalogue Number: PC0940XCE
• Device Lot Number: 17610396
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/08/2017
• Initial Date Manufacturer Received: 05/08/2017
• Initial Date FDA Received: 06/01/2017
• Supplement Dates Manufacturer Received: 07/31/2017
• Supplement Dates FDA Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening