MAUDE Adverse Event Report: COOK INC ULTRATHANE EXTENDED LENGTH SIDEPORTS BILIARY DRAINAGE CATHETER; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number	N/A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/21/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Investigation - evaluation: a review of the complaint history, functional test, drawings, device history record, instructions for use (ifu), manufacturing instructions, trends, quality control and a visual inspection of the returned device was conducted during the investigation.The device is shipped with an ifu which states the proper warnings, precautions, and instructions for use.The customer returned one used macloc catheter for investigation.The visual inspection of the returned device reported the catheter was received with the catheter shaft fractured approximately 2cm from the distal end of the flare cap.The macloc lever was in the closed position, and the proximal or luer lock end of the macloc had a clear colored injection cap attached.The distal section of the catheter shaft was not returned.Inspection revealed no visible cracks in the flare cap (hub) of the device, or the clear plastic injection cap attached to the proximal or luer lock end of the device.Further inspection of the fractured catheter end revealed the end to be smooth and not jagged or stretched, indicating the shaft was most likely cut in half.Leak testing was performed using a syringe filled with air, leakage from under the flare hub connection was confirmed.The hubs from cavity ii showed a difference in thread pitch leading to difficulty in achieving proper torque of the cap.This led to increased incidents of leakage and hub separation in 12 fr.Catheter¿s using parts made from cavity ii of the injection molding process.Although a definitive root cause cannot be determined, it is possible to suggest the flare was manufactured dimensionally incorrect, or that the cap was not properly torqued to the adapter, which caused the noted leakage during testing.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.Per the health risk assessment, no further action is required.
Event or Problem Description
It was reported the: "patient returned to dept one day after a biliary drain was inserted, staff found the hub was cracked.They replaced the drain with another one of a different lot#." "patient needed to return to have drain replaced".An fda report was received from the user facility which stated : "drain broke after patient arrived home, per patient they hadn't done anything unusual.Fluid stopped draining.Patient needed to return to the operating room for replacement.Further confirmation with the customer by the (b)(6) reported "the issue was where the catheter is connected to the hub where the luer lock connects ¿ it was leaking at the seam." a section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• Brand Name: ULTRATHANE EXTENDED LENGTH SIDEPORTS BILIARY DRAINAGE CATHETER
• Common Device Name: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6011596
• Report Number: 1820334-2016-01194
• Device Sequence Number: 92814
• Product Code: FGE
• UDI-Device Identifier: 00827002133556
• UDI-Public: (01)00827002133556(17)180428(10)5841873
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT12.0-38-40-P-CLBS-26-RH
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/22/2016
• Initial Report FDA Received Date: 10/07/2016
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention