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

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.

• 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 Key: 5534139
• MDR Text Key: 41768802
• Report Number: 3001845648-2016-00078
• Device Sequence Number: 1
• Product Code: FEG
• UDI-Device Identifier: 00827002214743
• UDI-Public: (01)00827002214743(17)180121(10)C1073938
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K851962
• Number of Events Reported: 1
• 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 Number: CLSO-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 Date: 11/17/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/03/2016
• Initial Date FDA Received: 03/30/2016
• Date Device Manufactured: 01/21/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 62