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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK IRELAND LTD COTTON-LEUNG BILIARY STENT; FEG TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

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COOK IRELAND LTD COTTON-LEUNG BILIARY STENT; FEG TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION Back to Search Results
Catalog Number CLSO-10-9
Device Problems Break (1069); Fracture (1260)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/17/2015
Event Type  malfunction  
Manufacturer Narrative
Limited information was provided by the customer if additional is received the complaint file will be updated.A possible cause of this complaint could be excessive force being applied by snares and forceps on extraction of the device.Excessive force might have being applied by end user due to the tortuous anatomy of the patient but this could not be confirmed.The root cause of this complaint cannot be conclusively determined, as the anatomy of the patient is unknown or use conditions.It may be noted that according to the instructions for use, the user is instructed to: ¿visually inspect with particular attention to kinks, bends and breaks.If any abnormality is detected that would prohibit proper working condition, do not use¿.As per (b)(4) functional checks there is 100% inspection on stents for kinks and a check that the appropriate size wire guide moves smoothly and freely when inserted into both ends of the stent.There is also a visual inspection of the product and packaging at packaging, packaging qc, and post sterile qc.A review of the manufacturing records for the biliary stent device of lot c1073938 did not reveal any discrepancy related to the complaint issue.Prior to distribution, all clso-10-9 devices are subjected to 100% inspection to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at (b)(4).The complaint has been assessed and the overall risk has been determined to be low.Complaints of this nature will continue to be monitored for potential emerging trends.
 
Event Description
When the surgeon grabbed common bile duct (cbd) stent with endo snare to remove the stent, the stent tore.Snare was replaced and the stent was removed.
 
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Brand Name
COTTON-LEUNG BILIARY STENT
Type of Device
FEG TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
Manufacturer (Section D)
COOK IRELAND LTD
o halloran road
limerick
Manufacturer Contact
sinead quaid
o'halloran road
national technology park
limerick 
061334440
MDR Report Key5534139
MDR Text Key41768802
Report Number3001845648-2016-00078
Device Sequence Number1
Product Code FEG
UDI-Device Identifier00827002214743
UDI-Public(01)00827002214743(17)180121(10)C1073938
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K851962
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Health Professional
Type of Report Initial
Report Date 03/01/2016
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
Device Operator Health Professional
Device Catalogue NumberCLSO-10-9
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date11/17/2015
Event Location Hospital
Initial Date Manufacturer Received 03/03/2016
Initial Date FDA Received03/30/2016
Date Device Manufactured01/21/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age31 YR
Patient Weight62
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