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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION VISTA BRITE TIP GUIDING CATHETERS; CARDIOLOGY GUIDING CATHETERS (DQY)
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CORDIS CORPORATION VISTA BRITE TIP GUIDING CATHETERS; CARDIOLOGY GUIDING CATHETERS (DQY) Back to Search Results
Catalog Number 67005400
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 10/03/2015
Event Type  malfunction  
Manufacturer Narrative
(b)(6).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
As reported, when taking the 100 cm.6 fr.Vista brite tip xb 3.5 guiding catheter (gc) out of the box, the sterile packaging was noted to be already a bit opened.There was no reported patient injury.The product is being returned for inspection.Additional information received indicated that the product was not re-opened and put back in the box.There was no damage noted to the packaging or the box.The product was not clinically used in a patient.Another guiding catheter was used to complete the procedure successfully.No additional information is available.
 
Manufacturer Narrative
As reported, when taking the 100 cm.6 fr.Vista brite tip xb 3.5 guiding catheter (gc) out of the box, the sterile packaging was noted to be already a bit opened.There was no reported patient injury.The product is being returned for inspection.Additional information received indicated that the product was not re-opened and put back in the box.There was no damage noted to the packaging or the box.The product was not clinically used in a patient.Another guiding catheter was used to complete the procedure successfully.No additional information is available.One non-sterile 6f.070 xb 3.5 100cm was received coiled in a plastic bag.Per visual analysis, the product package was not received for analysis.No other anomalies were found on the returned device.Review of lot 17259929 revealed no anomalies during the manufacturing and inspection processes that can be associated with the reported complaint.The event reported by the customer as ¿packaging/pouch/box - compromised sterility-seal open¿ could not be properly evaluated since the involved packaging/pouch/box was not received for analysis.The cause of the experience reported by the customer could not be determined.According to the product instructions for use, users are cautioned to not use open or damaged packages, as was done in this case.Neither the analysis nor the device history record review suggests that the event reported could be related to the manufacturing process.Therefore, no corrective or preventative actions will be taken at this time.
 
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Brand Name
VISTA BRITE TIP GUIDING CATHETERS
Type of Device
CARDIOLOGY GUIDING CATHETERS (DQY)
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 Key5221086
MDR Text Key31078601
Report Number9616099-2015-00554
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K021593
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Type of Report Initial,Followup
Report Date 10/22/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2018
Device Catalogue Number67005400
Device Lot Number17259929
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/05/2015
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/14/2015
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/05/2015
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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