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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CORDIS CORPORATION 6F10CM SW RADIAL INTRODUCER, CATHETER

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CORDIS CORPORATION 6F10CM SW RADIAL INTRODUCER, CATHETER Back to Search Results
Model Number 506610S
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/08/2021
Event Type  malfunction  
Manufacturer Narrative
Without a lot number to conduct a device history record (dhr) review, it is not possible to determine if the reported failure could be related to the manufacturing process. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported , a 6f10cm sw radial sheath was opened and there was a hair attached to the introducer. The device was not used in the patient. There was no patient injury. The device was opened in a sterile field and stored as per labeling. The device was not used in the patient and was opened on the sterile field and then the hair was noticed. Picture was provided, a single photograph was provided for review. Hair is noted to be attached to a device, thereby, compromising the device¿s sterility. The device will be returned for evaluation.
 
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Brand Name6F10CM SW RADIAL
Type of DeviceINTRODUCER, CATHETER
Manufacturer (Section D)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer (Section G)
CORDIS CORPORATION
14201 nw 60 avenue
miami lakes FL 33014
Manufacturer Contact
karla castro
14201 nw 60 avenue
miami lakes, FL 33014
7863138372
MDR Report Key12918938
MDR Text Key281921048
Report Number9616099-2021-05088
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K181592
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number506610S
Device Catalogue Number506610S
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/09/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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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