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 Fluid/Blood Leak (1250)

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

Event Date 09/27/2018

Event Type  malfunction  

Manufacturer Narrative

Occupation: unknown.Pma/510(k) #: pre-amendment.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported an ultrathane mac-loc locking loop biliary drainage catheter was placed in the patient for a biliary drainage procedure.Upon placement, leakage was discovered at the connection between the catheter and the hub.The catheter was replaced and the procedure was successfully completed.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Additional information including patient information has been requested.However, none has been received.The device will not be returned as it was disposed of at the user facility.

Manufacturer Narrative

Investigation - evaluation: a review of the device history record, documentation, drawing, instructions for use (ifu), manufacturing instructions, quality control and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.Based on the review of current documentation, inspection activities are in place to prevent the release of nonconforming product related to the reported failure mode.The risk specifications covering mac-loc drainage catheters include both hub separation and leakage as a potential failure mode.The identified risk controls include the manufacturing quality control checks and process validation.The technical files covering mac-loc catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.The instructions for use (ifu) advise the user to inspect the product prior to use to ensure that no damage has occurred.A review of the device history record was conducted for lot 8896703 and revealed two nonconformances for a fitting that was not properly secured and a curve which did not correspond with the template, all of which were scrapped.One nonconformance was found in mac-loc subassembly lot sa748970 for an extra hole in flash, which was scrapped.Four additional, unrelated nonconformances were found in tubing subassembly lot sa8765744 for foreign matter, rough coating, foreign matter and a bad pattern, of which all were scrapped.Three nonconformances were found in tubing subassembly lot sa8765742 for damage, foreign matter and irregular coating of which all were scrapped.It should be noted that there were no other complaints reported for lot 8896703.Based on the information provided, no returned product and the results of our investigation, a definitive cause could not be established.Appropriate measures have been taken to address this failure mode.Per the quality engineering risk assessment no further action is required.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

No new event description information to report at this time.

• 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
• MDR Report Key: 7965851
• MDR Text Key: 123806838
• Report Number: 1820334-2018-03073
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)210521(10)8896703
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/21/2021
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: 8896703
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1