MAUDE Adverse Event Report: CORDIS DE MEXICO PALMAZ BLUE .014 PERIPHERAL STENT SYSTEM; ENDOVASCULAR SDS/STENTS

Catalog Number PB1850PPX

Device Problems Delivered as Unsterile Product (1421); Unsealed Device Packaging (1444); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/01/2014

Event Type  malfunction  

Event Description

The report received from the affiliate indicated that the packaging of the 142 cm.Palmaz blue 5 x 50 stent mounted on an aviator plus balloon catheter/delivery system was open/not sealed.The physician did not clinically use the device in the patient.There was no reported patient injury.Additional information has been requested.

Manufacturer Narrative

The product is available for evaluation and testing.However, the product has not been returned as of to date.Additional information will be submitted within 30 days upon receipt.

Manufacturer Narrative

The device was returned for inspection on (b)(6) 2014.Additional information will be submitted within 30 days upon receipt.

Manufacturer Narrative

The report received from the affiliate indicated that the packaging of the 142 cm.Palmaz blue 5 x 50 stent mounted on an aviator plus balloon catheter/delivery system was open/not sealed.The physician did not clinically use the device in the patient.There was no reported patient injury.No additional information is available despite multiple attempts.The device was returned for analysis.One non sterile palmaz blue on aviator plus catheter was received inside a plastic bag.Neither the inner package nor the outer package were received with the device.The received product presented no visual anomalies.The dhr noted no anomalies related to the nature of this event.The reported packaging/pouch/box compromised sterility ¿ open seal could not be confirmed as the device received without the inner package for analysis.The exact cause could not be determined.Based on the limited information available for review, factors contributing to the reported open seal could not be determined.Neither the dhr nor the analysis suggests that the difficulty experienced by the customer could be related to the design and manufacturing process of the device; therefore, no corrective action will be taken at this time.

Manufacturer Narrative

Manufacturing record (dhr) review was conducted and the product met quality requirements for product acceptance per the applicable manufacturing quality plan.Additional information will be submitted within 30 days upon receipt.

• Brand Name: PALMAZ BLUE .014 PERIPHERAL STENT SYSTEM
• Type of Device: ENDOVASCULAR SDS/STENTS
• Manufacturer (Section D): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer (Section G): CORDIS DE MEXICO; circuito interior norte #1820; juarez, chihuahua 3258 0; MX 32580
• Manufacturer Contact: cecil navajas ; miami lakes, FL 33014 ; 63138802
• MDR Report Key: 4106679
• MDR Text Key: 4763037
• Report Number: 9616099-2014-00612
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K060877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/07/2015

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 Catalogue Number: PB1850PPX
• Device Lot Number: 15856529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2015
• Initial Date FDA Received: 09/22/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 10/27/2014; 11/26/2014; 01/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2013
• 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