MAUDE Adverse Event Report: CORDIS CORPORATION PRECISE SDS SELF EXPANDING; SELF EXPANDING STENTS (FGE)

Model Number PC0630RXC

Device Problems Difficult or Delayed Positioning (1157); Material Frayed (1262); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

As reported by the contact a precise pro was prematurely deploy as it was being loaded on the wire.There was no report of patient injury.

Manufacturer Narrative

Please note that device evaluated by mfg? appropriate value is "no." the device has been returned for analysis; however, the engineering report is not yet available.It will be submitted within 30 days upon receipt.A device history record (dhr) and additional information are pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.A device history record (dhr) review was conducted and the product met quality requirements for product acceptance.Product analysis: one non-sterile precise pro rx us carotid syst 6x30mm was received coiled inside a plastic bag.Unit was deployed.Stent was not received.Hemostasis valve was received closed.Brite tip was received frayed.No other discrepancies were found.The usable length was measured and found within specification.Although the unit was received deployed; functional test (deployment process) was performed according to procedure and no anomalies were found.The unit was sent to sem analysis in order to analyze the potential cause of brit tip frayed; sem results showed that the brite tip surface presented evidence of elongation at the surrounding areas of the frayed.Elongation is a common characteristic of pieces which were stretched/ pulled.Stretching/ pulling could have been related to these characteristic.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.The failure reported ¿catheter tip - frayed/split/torn (carotid)¿ by the customer was confirmed; the cause of the failure was not conclusively determined.According to sem results the failure does not appear to be manufacturing related due to presented evidence of elongation at the surrounding areas of the frayed.Neither the dhr review nor the analysis suggests that the failure is manufacturing related.During manufacturing process there are controls to detect this kind of issue.Therefore no actions were taken.The failure "sds - deployment difficulty-premature/during prep" reported by the customer could not be confirmed since unit was received deployed.The exact cause of the reported failure condition could not be conclusively determined.Neither the dhr review nor the product analysis suggests that the failure is related to the manufacturing process.Therefore no actions will be taken.After analysis of the device, it was noted that the catheter tip was frayed.(b)(4).

Manufacturer Narrative

Method codes- visual inspection.(b)(4).Complaint conclusion: as reported by the contact a precise pro was prematurely deployed as it was being loaded on the wire.After analysis of the device, it was noted that the catheter tip was frayed.One non-sterile precise pro rx us carotid syst 6x30mm was received coiled inside a plastic bag.Unit was deployed.Stent was not received.Hemostasis valve was received closed.Brite tip was received frayed.No other discrepancies were found.The usable length was measured and found within specification.Although the unit was received deployed; functional test (deployment process) was performed according to procedure and no anomalies were found.The unit was sent to sem analysis in order to analyze the potential cause of brit tip frayed; sem results showed that the brite tip surface presented evidence of elongation at the surrounding areas of the frayed.Elongation is a common characteristic of pieces which were stretched/ pulled.Stretching/ pulling could have been related to these characteristic.A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint.The failure reported ¿catheter tip - frayed/split/torn (carotid)¿ by the customer was confirmed; the cause of the failure was not conclusively determined.According to sem results the failure does not appear to be manufacturing related due to presented evidence of elongation at the surrounding areas of the frayed.Neither the dhr review nor the analysis suggests that the failure is manufacturing related.During manufacturing process there are controls to detect this kind of issue.Therefore no actions were taken.The failure "sds - deployment difficulty-premature/during prep" reported by the customer could not be confirmed since unit was received deployed.The exact cause of the reported failure condition could not be conclusively determined.Neither the dhr review nor the product analysis suggests that the failure is related to the manufacturing process.Therefore no actions will be taken.Based on the information available, it appears that the brite tip frayed condition experienced by the user may have been caused by the operational context of the device and is not related to a product quality issue.With the limited amount of information available it is not possible to draw a clinical conclusion between the device and the reported stent pre-mature deployment.

Manufacturer Narrative

Please note that the event date remains unknown at this time.Correction: please note that is this a single-use device that was reprocessed and reused on a patient?" was inadvertently checked in the initial medwatch report.The device was not reprocessed or reused.All other information remains unchanged.

• Brand Name: PRECISE SDS SELF EXPANDING
• Type of Device: SELF EXPANDING STENTS (FGE)
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL
• Manufacturer Contact: cecil navajas ; circuito interior norte #1820; juarez chihuahua 32580 ; MX 32580 ; 7863133880
• MDR Report Key: 4137631
• MDR Text Key: 4929429
• Report Number: 9616099-2014-00635
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K012993
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/05/2014

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: 03/31/2015
• Device Model Number: PC0630RXC
• Device Catalogue Number: PC0630RXC
• Device Lot Number: 15848946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/05/2014
• Initial Date FDA Received: 10/03/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 10/07/2014; 11/07/2014; 11/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CONCOMITANT DEVICES: UNKNOWN GUIDEWIRE