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 Fitting Problem (2183)

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

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) #: pre-amendment.(b)(4).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 a patient needed an ultrathane mac-loc locking loop biliary drainage catheter exchanged on an unspecified date due to the hub separating from the catheter.The catheter had been placed in the liver for biliary drainage.The compliant device was successfully replaced with an unspecified biliary drainage catheter.

Manufacturer Narrative

Investigation - evaluation: a review of the documentation, instructions for use (ifu) and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.A customer provided image of the device shows what appears to be the hub snapped in half where the threads attach to the locking mechanism.Additionally, 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.A review of the device history record was unable to be conducted due to an unknown lot number.The instructions for use (ifu) advise the user to inspect the device prior to use to ensure that no damage has occurred.There is no additional information regarding maintenance of the device.It would require a great deal of force to snap this device in half.It is unlikely that normal care of the device or normal tension from drainage bags could cause this.At this time, the most probable cause is device failure related.However, an attempt to alter the device or attempt to unscrew the device at the threads cannot be entirely ruled out.Based on the information provided, no returned product and the results of our investigation, a likely cause could be traced to a component failure although this could not be confirmed.Per the quality engineering risk assessment no further action is required.Cook will continue to monitor for similar complaints.

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: 7823782
• MDR Text Key: 118540048
• Report Number: 1820334-2018-02361
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• 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: UNKNOWN
• Date Manufacturer Received: 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1