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 Leak/Splash (1354)

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

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Occupation: lead tech.Pma/510(k) #: pre-amendment.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported an unknown patient required placement of a ultrathane mac-loc locking loop biliary drainage catheter for a biliary drainage procedure.The operator reported the drainage catheter was leaking at the hub.The device was replaced with a similar device to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.D10 ¿ product received on: 30sep2019.Investigation ¿ evaluation: a review of the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, as well as a visual inspection, functional test, and dimensional verification, were conducted during the investigation.The complaint device was returned for investigation.Physical examination of the returned device showed biomatter throughout the device, but no immediate surface damage was noted.A leak test was performed, and a leak was confirmed at the syringe-to-hub interface.Upon further inspection of the leakage site, a crack was noted on the luer lock portion of the mac-loc hub.All dimensions deemed relevant to the reported failure mode were analyzed and confirmed that the device was manufactured within specifications.Additionally, a document based investigation evaluation was performed.The proper procedures are in place to identify and prevent this failure mode prior to device distribution.The risk specifications covering mac-loc drainage catheters include both hub separation and leakage as a potential failure mode.The identified risk controls include manufacturing quality control checks and process validation.The technical files covering mac-loc drainage catheters indicate that the risks associated with these devices are acceptable when weighed against the benefits.The device history record (dhr) for the complaint lot and relevant subassemblies revealed no nonconformances relevant to the reported failure mode.A database search revealed no other complaints have been reported for the device lot.At this time, there is no evidence suggesting that nonconforming product from this lot exists in house or in the field.Based on the information provided, the examination of the returned product, and the results of the investigation, it was concluded that a component failure without manufacturing or design issue contributed to this incident.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.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 additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• 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: 9107003
• MDR Text Key: 159785964
• Report Number: 1820334-2019-02392
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094994
• UDI-Public: (01)00827002094994(17)220618(10)9820235
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT12.0-38-40-P-32S-CLB-RH
• Device Lot Number: 9820235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1