• 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 5F10CM 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 5F10CM SW RADIAL INTRODUCER, CATHETER Back to Search Results
Model Number 506510S
Device Problems Break (1069); Difficult to Remove (1528); Mechanical Jam (2983)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/22/2022
Event Type  malfunction  
Manufacturer Narrative
A review of the manufacturing documentation associated with lot 18068607 presented no issues during the manufacturing process that can be related to the reported event. Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, the last piece of the the 5f 10cm rain sheath was noted to be stuck in the vessel when removing. After removal from the patient, it was noted that the last 0. 5cm of the tip was damaged. It was confirmed that there was no damage to the sheath prior to inflating the tr band. There was no difficulty using the sheath during the procedure, prior to inflating the tr band. There was no reported injury to the patient. This occurred at the end of the procedure, after the tr-band was inflated and the sheath was being removed. The tr-band was deflated; however it did not recover its original shape. The sheath was removed with a quick movement, and the tr -band was inflated again. The device will be returned for evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name5F10CM 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 Key15109234
MDR Text Key301262591
Report Number9616099-2022-05850
Device Sequence Number1
Product Code DYB
UDI-Device Identifier10705032078917
UDI-Public(01)10705032078917(17)241031(10)18068607
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K181592
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 08/29/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/27/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number506510S
Device Catalogue Number506510S
Device Lot Number18068607
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/24/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/13/2021
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: 07/27/2022 Patient Sequence Number: 1
Treatment
TR BAND-COMPRESSION DEVICE
-
-