• 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 ANSEL 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 ANSEL GUIDING SHEATH DYB INTRODUCER, CATHETER Back to Search Results
Model Number G29982
Device Problem Split (2537)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/13/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Pma/510(k) number
=
pre-amendment. This report includes information known at this time. A follow-up report will be submitted should additional relevant information become available.
 
Event Description
It was reported that during an internal iliac aneurysm embolization procedure of the small vessels, the dilator of the flexor ansel guiding sheath was split. The sheath and dilator were prepared and advanced over the wire into the patient's artery. The surgeon felt some resistance and removed the dilator and sheath and found the dilator was split. The surgeon opened a new sheath and continued the procedure. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence. A section of the device did not remain inside the patient¿s body.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFLEXOR ANSEL 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
jennifer canada
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key7468698
MDR Text Key106973606
Report Number1820334-2018-00828
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K142829
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/26/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/01/2021
Device Model NumberG29982
Device Catalogue NumberKCFW-6.0-18/38-45-RB-ANL1-HC
Device Lot Number8554623
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/25/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-