MAUDE Adverse Event Report: COOK INC ULTRATHANE RING BILIARY DUCT DRAINAGE CATHETER; GCA CATHETER, BILIARY, DIAGNOSTIC CATHETER, NEPHROSTOMY

Model Number N/A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Code Available (3191)

Event Date 08/11/2017

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

International customer reported that a patient underwent placement of a ultrathane ring biliary duct drainage catheter for percutaneous transhepatic cholangiodrainage.The customer indicates that the white hub connector disconnected from the catheter at an unspecified time following initial placement.The circumstances and handling conditions leading to the event are not known.The catheter was explanted and replaced with a new device.The actual device is not available for evaluation.This is one of three medwatch reports being submitted as the customer reported three separate events.Reference mdr numbers 1820334-2017-02362, 1820334-2017-02363 for all associated reports.

Manufacturer Narrative

Investigation summary: a review of the instructions for use (ifu), manufacturing instructions, trends, and quality control was conducted during the investigation.No issues were found related to the reported complaint.The complaint device was not returned; therefore no physical examination could be performed.The lot number of the device is not known; accordingly a review of the device history record and complaint history of the lot could not be conducted.The manufacturing documents in place at the time of manufacture were reviewed, and it was found that the device aspect in question was visually inspected by quality control and no notable gaps in production or processing controls were noted.The risk specification for this product includes the separation failure mode and identifies that multiple risk controls are in place to mitigate the risk of this type of failure.The manufacturing process validation for the proximal assembly is validated for both tensile strength and leakage.The product ifu lists warnings and precautions as well as instructions for proper use and placement of this device.The ifu states in the how supplied section, "upon removal from package, inspect the product to ensure no damage has occurred." the device was not returned for evaluation.There is no evidence to suggest that this device was not made to specification.The root cause is unknown at this time.The manufacturing process validation for proximal assembly validates the proximal assembly process for both tensile strength and leakage, and includes information to reduce the risk of incorrect flaring or torqueing of the assembly.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: ULTRATHANE RING BILIARY DUCT 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 ; 8128294891
• MDR Report Key: 6816233
• MDR Text Key: 83460267
• Report Number: 1820334-2017-02364
• Device Sequence Number: 1
• Product Code: GCA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-50-P-32S-RING
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2017
• 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 Outcome(s): Required Intervention