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

MAUDE Adverse Event Report: COOK INC FLEXOR GUIDING SHEATH DYB 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
 

COOK INC FLEXOR GUIDING SHEATH DYB INTRODUCER, CATHETER Back to Search Results
Model Number G13032
Device Problems Material Frayed (1262); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/15/2021
Event Type  malfunction  
Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable. Occupation: lead tech. This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.
 
Event Description
As reported, upon opening the packaging of a flexor guiding sheath, the tip of the dilator was noted to be frayed. This was noted while prepping for the procedure, away from the sterile field. The device did not make patient contact. A new same-type device was opened and used to successfully complete the procedure. No adverse events were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFLEXOR GUIDING SHEATH
Type of DeviceDYB INTRODUCER, CATHETER
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer (Section G)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
jason crouch
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key13117709
MDR Text Key289441460
Report Number1820334-2021-02752
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00827002130326
UDI-Public(01)00827002130326(17)241028(10)14315460
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K142829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberG13032
Device Catalogue NumberKCFW-10.0-38-30-RB
Device Lot Number14315460
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received04/06/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/28/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-