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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
Model Number N/A
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/27/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).A device history record review was performed and showed that this lot of products met all requirements per the applicable manufacturing quality plan.The product is available for evaluation and testing; however, it has not been received to date.Additional information will be submitted within 30 days of receipt.
 
Event Description
Before the procedure and during preparation of the vista brite tip guiding catheter, it was noted that a long piece of plastic came out of the tip of the catheter.The catheter was flushed with a mixture of water and heparin.There was no report of patient injury.Picture has been provided.The product will be returned for analysis.No additional information is available.
 
Manufacturer Narrative
The product has been returned for evaluation and testing; however, the engineering evaluation has not been completed.Additional information will be submitted within 30 days of receipt.
 
Manufacturer Narrative
Before the procedure and during preparation of the vista brite tip guiding catheter, it was noted that a long piece of plastic came out of the tip of the catheter.The catheter was flushed with a mixture of water and heparin.There was no report of patient injury.A picture has been provided.No additional information is available.A non-sterile unit of 6f.070 xb 3.5 100cm was received inside of a plastic bag.A guiding catheter and a foreign material were received for analysis.Three kink conditions were observed on the body at 30 cm, 55.3 cm and 93 cm from distal tip.A loose foreign material, which appears to be ptfe material, was received inside of the bag outside of the device.The foreign material was inspected under the vision system and fluff was observed attached to foreign material.A pet meeting was help to inspect the foreign material received and determined that ftir analysis was required.Infrared spectroscopy was applied to identify the chemical composition the foreign material.Based off the ir data obtained from the particles analyzed, the loose particle found on the 6f.070 xv 3.5 100cm catheter is primarily composed of polytetrafluoroethylene (ptfe).The comparison test with the foreign material and the ptfe tube reference reveals that both samples share the same infrared spectrum pattern.The catheter was opened by the pet team and no damages were observed on the internal components.Review of lot 17452529 revealed no anomalies during the manufacturing and inspection processes.The complaint reported by the customer as ¿catheter (body/shaft)/ foreign material-during prep¿ was confirmed due to the loose foreign material received.The ftir results confirmed the foreign mater found during analysis to be of ptfe material.The cause of the event was related to a manufacturing process.According to the product instruction for use, users should not use the product if it is opened or damaged as was done in this case.A risk assessment has been initiated to evaluate this issue.
 
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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 Key5748367
MDR Text Key48137433
Report Number9616099-2016-00396
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K021593
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup
Report Date 06/02/2016
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 Date02/28/2019
Device Model NumberN/A
Device Catalogue Number67005400
Device Lot Number17452529
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/08/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/02/2016
Initial Date FDA Received06/24/2016
Supplement Dates Manufacturer ReceivedNot provided
Not provided
Supplement Dates FDA Received07/11/2016
08/02/2016
Date Device Manufactured04/14/2016
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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