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

Model Number PC1040RXC

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2017

Event Type  malfunction  

Manufacturer Narrative

Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan.  the product was returned for evaluation and testing; however, the engineering evaluation is not complete.Additional information will be submitted within 30 days upon receipt.

Event Description

The report received indicted that during a carotid artery stenting (cas) procedure, the physician experienced difficulty advancing the precise pro rx 10 x 40 stent delivery system (sds) over the unknown guidewire and a crack of the sds distal tip was noted.Another product was used to complete the procedure successfully. there was no reported patient injury.The product was clinically used and it will be returned for analysis.The target lesion was unknown and no target lesion characteristic information was provided.The approach for the procedure was femoral.The reported product issue occurred after pre-dilation using a non-cordis balloon catheter and an unknown guiding catheter.Additional information received indicated that it was unknown if the guidewire used was a cordis product.There was no reported product issue with the guidewire used.It was not known if the same guidewire was used subsequently with other devices or if the crack reported was to the distal tip, deployment sheath, or stent delivery system (sds).The product was stored properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.The product was prepped properly according to the ifu with no problems noted during preparation.Additional information including target lesion information was requested but was reported to be unknown.No additional information is available.

Manufacturer Narrative

During a carotid artery stenting (cas) procedure, the physician experienced difficulty advancing the precise pro rx 10 x 40 stent delivery system (sds) over the unknown guidewire and a crack of the sds distal tip was noted.Another product was used to complete the procedure successfully.There was no reported patient injury.The target lesion was unknown and no target lesion characteristic information was provided.The approach for the procedure was femoral.The reported product issue occurred after pre-dilation using a non-cordis balloon catheter and an unknown guiding catheter.Additional information received indicated that it was unknown if the guidewire used was a cordis product.There was no reported product issue with the guidewire used.It was not known if the same guidewire was used subsequently with other devices or if the crack reported was to the distal tip, deployment sheath, or stent delivery system (sds).The product was stored properly according to the instructions for use (ifu).There was no damage noted to the product packaging upon inspection prior to use.There was no reported difficulty removing the product from the packaging.The product was inspected prior to use and appeared to be normal.The product was prepped properly according to the ifu with no problems noted during preparation.Additional information including target lesion information was requested but was reported to be unknown.No additional information is available.  the product was returned for analysis.One non-sterile precise pro rx us carotid syst unit was returned.Per visual analysis the stent had not been deployed and the inner member¿s distal tip was noted over-captured on the brite tip.A cracked condition was noted on the brite tip.Dried blood residues were noted on catheter¿s distal section.No other damages or anomalies were noted.The involved guide wire was not returned.Per functional analysis a 0.014¿ guide wire lab sample was inserted through the catheter wire lumen and no resistance was felt.Per microscopic analysis the tip was noted to be cracked or ruptured and the area revealed evidence of elongations and frayed edges.Elongations and frayed edges are a common characteristic of a device which was stretched or pulled until separation.Based on the available evidence, it is possible that a stretching/pulling events may be related the tip cracked/rupture condition found.A device history record (dhr) review of lot 17502435 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 tracking difficulty¿ was not confirmed through analysis of the returned device as functional analysis was completed successfully.The exact cause of the event could not be determined during analysis.The reported ¿catheter tip cracked - in patient¿ 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 event as evidenced by evidence of elongations and frayed edges noted on the cracked surface during analysis indicative of excess force being applied to the device.According to the instructions for use, which is not 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 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.

• Brand Name: PRECISE PRO RX US CAROTID SYST
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave.; miami lakes FL 33140
• 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: 6636921
• MDR Text Key: 77536338
• Report Number: 9616099-2017-01168
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 20705032036556
• UDI-Public: 20705032036556
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: PC1040RXC
• Device Catalogue Number: PC1040RXC
• Device Lot Number: 17502435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/22/2017
• Date Manufacturer Received: 07/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/29/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1