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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION GC 9F .098 STR 55CM CATHETER, PERCUTANEOUS

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CORDIS CORPORATION GC 9F .098 STR 55CM CATHETER, PERCUTANEOUS Back to Search Results
Model Number 598943P
Device Problems Device Contamination with Chemical or Other Material (2944); Manufacturing, Packaging or Shipping Problem (2975)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/20/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). The customer complained of particles being inside sterile field of packaging. According to customer: "we¿re inspecting our most recent shipment of guide catheters, and we noticed there are some particles in the pouches. They are likely from the paperboard backing to which the guide catheter is attached. I¿ve attached images that best exemplifies this. " the integrity of the sterile pouch was not compromised. The actual product was not damaged. There was no damage to the outer product box. It is unknown if there were other particles noted elsewhere in the pouch besides what was shown in the pictures. Per photos provided it looks as if the cardboard backing that the guide catheter is attached to wasn't cleanly cut and so there are frays of cardboard. Additional information received from product analysis including that the particles found in the pouch are frays of cardboard that are still attached to the cardboard. Two products were returned for analysis. Two sterile gc 9f. 098 str 55cm guide catheters were received in their corresponding package. Per visual analysis, it can be noticed that the outer boxes were received opened, torn and crushed. One vista brite tip guiding catheter was inside of each box. The inner packages were visually analyzed, and one yellow sticky note with an arrow pointing a mounting card tab on each catheter was found. Some frays of cardboard attached to the mounting cards tabs were found. After this, the inner pouches were fully reviewed, and no loose pieces were found. A product history record (phr) review of lot 17746147 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event. The complaint reported by the customer as ¿packaging/pouch/box - foreign material - in sterile package¿ was confirmed, due to some frays of cardboard attached to the mounting cards tabs were observed. This material is part of the mounting card material and were not cleanly cut. The inner pouches were fully reviewed, and no loose pieces of cardboard were found. According to the safety information in the instructions for use ¿inspect the guiding catheter before use to verify that its size, shape and condition are suitable for the specific procedure. ¿ the product analysis suggests that the event experienced by the customer could be related to the manufacturing process; therefore a corrective/preventive action will be taken at this time.
 
Event Description
As reported, the customer complained of particles being inside sterile field of packaging. Judging by photos, it looks as if the cardboard backing that the guide catheter is attached to wasn't cleanly cut and so there are frays of cardboard. According to customer: "we¿re inspecting our most recent shipment of guide catheters, and we noticed there are some particles in the pouches. They are likely from the paperboard backing to which the guide catheter is attached. I¿ve attached images that best exemplifies this. " the integrity of the sterile pouch was not compromised. The actual product was not damaged. There was no damage to the outer product box. It is unknown if there were other particles noted elsewhere in the pouch besides what was shown in the pictures. Two of the 64 devices will be returned for analysis. Additional information received from product analysis including that the particles found in the pouch are frays of cardboard that are still attached to the cardboard.
 
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Brand NameGC 9F .098 STR 55CM
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60th ave
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60th ave
miami lakes, FL 33014
7863138372
MDR Report Key8105817
MDR Text Key128421844
Report Number9616099-2018-02558
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K925131
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other Health Care Professional
Remedial Action Recall
Type of Report Initial,Followup,Followup,Followup
Report Date 04/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2020
Device Model Number598943P
Device Catalogue Number598943P
Device Lot Number17746147
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/15/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/10/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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