• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

CORDIS CORPORATION 6F10CM SW RADIAL INTRODUCER, CATHETER Back to Search Results
Model Number 506610S
Device Problem Peeled/Delaminated (1454)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2020
Event Type  malfunction  
Manufacturer Narrative
A review of the manufacturing documentation associated with this lot presented no issues during the manufacturing process that can be related to the reported complaint. This device is available for analysis but the engineering report is not yet available. However, it will be submitted within 30 days upon receipt. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
When a 6f 10cm sw transradial rain sheath introducer was pushed in, the hydrophilic coating was pushed together. Therefore, the sheath has been removed and continued with the non-cordis sheath. There was no reported patient injury. The user is still in training with the device. The device was opened in a sterile field. The sheath was well watered just before insertion. The device will be returned for evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11099847
MDR Text Key224521195
Report Number9616099-2020-04165
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K984500
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number506610S
Device Catalogue Number506610S
Device Lot Number17972089
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/11/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/31/2020 Patient Sequence Number: 1
Treatment
MERRIT SHEATH
-
-