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 Break (1069)

Patient Problem No Code Available (3191)

Event Date 01/03/2018

Event Type  Injury  

Manufacturer Narrative

Pma / 510k status: preamendment.(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

The reporter stated that the hub of the ultrathane mac-loc locking loop biliary drainage catheter broke off during the night.The device was implanted on (b)(6) 2018, and the product problem was discovered on (b)(6) 2018.The issue ultimately necessitated the replacement of the device with another product of the same type.The device was in place less than 24 hours total.The reporter was asked about where the drainage catheter was placed in order to determine what type of drainage was being drained and the reporter was not able to provide any details.The device has been received for evaluation, but as of the date of this report, the investigation is still pending.

Manufacturer Narrative

Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, documentation, instructions for use (ifu), manufacturing instructions, specifications, quality control, and visual inspection of the returned device was conducted during the investigation.One used catheter with biomatter was returned with the catheter tubing completely separated from the proximal assembly.The mac-loc appeared did not have any apparent cracks or defects.The flare looked concentric with no damage from being pulled form the proximal assembly.The flare was measured and the outer diameter was smaller than the specification.A review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The complainant device lot number is unknown.Thus, a review of the device history record, nonconformance history, and related product complaints query could not be conducted.Based on the provided information, inspection of returned product and the results of our investigation; a definitive root cause could not be determined.However, it is possible that the reported issue is related to the flare being too small due to a decrease in the size of the outer diameter.Measures have been previously initiated to address this issue.Per the quality engineering risk assessment, no further action is required.Appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• 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: 7217265
• MDR Text Key: 98166459
• Report Number: 1820334-2018-00153
• 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: 02/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• 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: ULT8.5-38-40-P-32S-CLB-RH
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention