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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

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COOK INC ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY Back to Search Results
Catalog Number ULT8.5-38-40-P-32S-CLB-RH
Device Problem Crack (1135)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/24/2015
Event Type  Malfunction  
Manufacturer Narrative

This mdr is being filed after the associated complaint was reviewed under remediation protocol cap008, complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.

 
Event Description

During the procedure, leakage was found at the distal of drainage catheter,the physician removed the whole catheter from the patient and changed to a new catheter to finish the procedure. After inspection the crack was found at the end of the catheter. A section of the device did not remain inside the patient¿s body. The patient did not require any additional procedures due to this occurrence. According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

 
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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 Key7016057
MDR Text Key92746801
Report Number1820334-2017-03988
Device Sequence Number1
Product Code GCA
Combination Product (Y/N)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,HEALTH PROFESSIONAL,U
Reporter Occupation
Type of Report Initial
Report Date 11/09/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/09/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberULT8.5-38-40-P-32S-CLB-RH
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2017
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured04/06/2015
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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