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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
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ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY Back to Search Results
Catalog Number ULT10.2-38-40-P-32S-CLB-RH
Health Effect - Clinical Code Foreign Body In Patient (2687)
Date of Event 01/13/2015
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
 
Event or Problem Description
After the drain was placed, it began to leak at the junction between the catheter and the hub.It was needed to be screwed back together.A section of the device remained inside the patients body was it was intended as the initial drainage catheter was removed and replaced with a new catheter successfully.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
 
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Brand Name
ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
Common Device Name
GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY
MDR Report Key7007757
Report Number1820334-2017-03940
Device Sequence Number13872254
Product Code GCA
UDI-Device Identifier00827002094987
UDI-Public(01)00827002094987(17)171104(10)5415317
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 11/07/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Catalogue NumberULT10.2-38-40-P-32S-CLB-RH
Was Device Available for Evaluation? Yes
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 11/07/2017
Initial Report FDA Received Date11/07/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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