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.The packaging is not being returned with the complaint product.The product was stored properly according to the ifu.There was no reported possibility the product was opened and then returned to storage.There was no damage noted to the product packaging upon inspection prior to opening.The procedure was completed successfully although details were not provided.The target lesion was the renal artery.No other product issue was noted upon inspection of the product after removal from the patient.No additional information is available.

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 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.The packaging is not being returned with the complaint product.The product was stored properly according to the ifu.There was no reported possibility the product was opened and then returned to storage.There was no damage noted to the product packaging upon inspection prior to opening.The procedure was completed successfully although details were not provided.The target lesion was the renal artery.No additional information is available.One non sterile palmaz blue on aviator plus, 5 mm diameter, 50 mm length, on 142 cm catheter was received coiled in a plastic bag.Neither the inner package nor the outer package were received with the device.Review of dhr for lot 15856529 noted no issues were noted that were considered potentially related to the reported complaint.The reported ¿packaging/pouch/box compromised sterility-seal open¿ was not confirmed as the inner package was not received for analysis.Based on the information available for review, clinical factors which may have contributed to the difficulty experienced by the customer could not be determined.Without return of the sterile pouch and based on the dhr, there is nothing to suggest a design or manufacturing related cause for this event.Therefore, no corrective action will be taken at this time.

Manufacturer Narrative

The product was returned for analysis on 10/15/2014.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: 4106712
• MDR Text Key: 4714874
• Report Number: 9616099-2014-00613
• 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
• Report Date: 11/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2014
• 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: 10/15/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2014
• 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