MAUDE Adverse Event Report: COOK INC ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/10/2017

Event Type  malfunction  

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

International customer reported that a ultrathane mac-loc locking loop biliary drainage catheter was being placed.The blue stiffener reportedly could not be removed during the implantation process.The devices were removed and exchanged.There were no reported adverse patient consequences.The devices are available for evaluation but have not been received by the manufacturer as of the date of this report.

Manufacturer Narrative

Investigation - evaluation: a review of complaint history, quality control, drawing, manufacturing instructions, specifications and instructions for use was conducted during the investigation.The product will not be returned for the investigation.If the device becomes available complaint will be reopened and investigation will be performed at that time.There was no evidence to suggest the device was manufactured out of specification, nonconforming in house, or nonconforming in the field.Since none of the devices were returned by the user, the root cause is inconclusive.One potential cause of failure could be an interference fit between the cannula and the catheter.The device is currently designed to be compatible with the catheter according to drawing and the diameters of each are quality control checked.It was concluded that no further risk reduction is required at this time.Quality control ensures 100% verification for the material type and french size.In addition, the surface is checked to be clean and free of damage.The surface of the catheter is checked to be free of excessive dents and foreign matter, and the catheter is checked to ensure the flexible stiffener will pass through completely.An instruction for use (ifu) is sent with every device that outlines the proper instructions for using this product.We will notify the appropriate personnel and continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: ULTRATHANE MAC-LOC LOCKING LOOP BILIARY DRAINAGE CATHETER
• Type of Device: GCA 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 Key: 6629867
• MDR Text Key: 77500875
• Report Number: 1820334-2017-01345
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)191103(10)7416373
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/24/2017

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
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2017
• Initial Date FDA Received: 06/09/2017
• Supplement Dates Manufacturer Received: 08/08/2017
• Supplement Dates FDA Received: 08/24/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2016
• 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