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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
Model Number N/A
Device Problems Crack (1135); Fluid Leak (1250)
Patient Problem No Code Available (3191)
Event Date 09/15/2017
Event Type  Injury  
Manufacturer Narrative

(b)(4). The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

 
Event Description

The customer reported that, a few hours following the conclusion of the biliary tube placement using a ultrathane mac-loc locking loop biliary drainage catheter, the patient's caregiver reported that the catheter was leaking bile from the plastic end cap. The catheter was ultimately exchanged as a result. A physician examined the device and noted the crack to clearly be at the junction of the end cap of the catheter and the actual catheter portion of the device. The catheter was cut to facilitate its removal and exchange, but the catheter and end cap were both saved for return. The circumstances surrounding the usage and handling of the device prior to the leakage were not reported. The device has been received for evaluation; however, the investigation is still pending.

 
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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
8123392235
MDR Report Key6910655
MDR Text Key88019608
Report Number1820334-2017-03434
Device Sequence Number1
Product Code GCA
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/06/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/03/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberN/A
Device Catalogue NumberULT14.0-38-40-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 Received11/27/2017
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

Patient TREATMENT DATA
Date Received: 10/03/2017 Patient Sequence Number: 1
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