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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS DE MEXICO PALMAZ BLUE .014 PERIPHERAL STENT SYSTEM; ENDOVASCULAR SDS/STENTS
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CORDIS DE MEXICO PALMAZ BLUE .014 PERIPHERAL STENT SYSTEM; ENDOVASCULAR SDS/STENTS Back to Search Results
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.
 
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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 Key4106679
MDR Text Key4763037
Report Number9616099-2014-00612
Device Sequence Number1
Product Code FGE
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K060877
Number of Events Reported1
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
Date FDA Received09/22/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2015
Device Catalogue NumberPB1850PPX
Device Lot Number15856529
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/07/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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