• 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 ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY

  • 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 ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY Back to Search Results
Model Number N/A
Device Problems Physical Resistance (2578); Wrinkled (2614)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/02/2018
Event Type  Malfunction  
Manufacturer Narrative

G510 status: preamendment. (b)(4). This report includes information known at this time. A follow up report will be submitted should additional relevant information become available.

 
Event Description

The international customer reported the ultrathane mac-loc locking loop biliary drainage catheter and stylet did not separate during percutaneous transhepatic biliary drainage. The catheter was removed from the body. The catheter was wrinkled without being removed when the stylet was pulled. There were no adverse events were reported. The patient did not require any additional procedures. The product has been received for evaluation; however, as of the date of this report, the investigation is still pending.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
Type of DeviceGCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8128294891
MDR Report Key7226059
MDR Text Key98973232
Report Number1820334-2018-00239
Device Sequence Number1
Product Code GCA
Combination Product (Y/N)N
Reporter Country CodeKR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/26/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/29/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberULT8.5-38-40-P-32S-CLB-RH
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 Received02/26/2018
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-