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 Date 03/04/2020

Event Type  malfunction  

Manufacturer Narrative

Age: patient is in their "late 50's".Occupation: lead tech.Pma/510(k) #: preamendment.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 male patient required placement of an ultrathane mac-loc locking loop biliary drainage catheter for drainage of the bile duct.After the catheter was placed, leaking at the hub was noticed.The device was replaced with another device of the same lot.When the physician pulled on the string to create the pigtail loop on the catheter, the string broke.The device was replaced with a new, 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.The first catheter that leaked at the hub is recorded under the medwatch report with patient identifier (b)(6) (this report).The catheter that experienced suture breakage is recorded under the medwatch report with patient identifier (b)(6).

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Event Description

Device was returned to the manufacturer on (b)(6) 2020 with the hub separated from the catheter shaft.It appears to have been cut.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.D10 product received on: 13mar2020.Investigation evaluation.Dmg interventional radiology informed cook of an incident involving a ultrathane mac-loc locking loop biliary drainage catheter.During a biliary drain insertion procedure the device was successfully placed in the patient when they noticed the catheter was leaking at the hub.Another similar device was used.No adverse patient effects were reported.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, and functional test, were conducted during the investigation.One used 8.5 fr mac-loc was returned with biomatter throughout the device.The device was returned with the hub cut off the catheter.No other damage was noted on the device.A leak test was performed and the device leaked where the tubing enters the cap.The device passed the distance measurement between the cap and the hub.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 ifu supplied with the mac-loc drainage catheters instruct that the product should be inspected prior to use to ensure no damage has occurred.A review of the device history record (dhr) showed one related non-conformance for "surface defect".This affected a quantity of two that was scrapped.A database search revealed one additional complaint for the lot number.This complaint was reported from the same user facility for the same procedure on the same patient for a different failure mode of ¿string broke.¿ at this time, cook could not conclude that nonconforming product from this lot exists in house or in the field.Based on the information provided, inspection of returned product, and results of the investigation, it was concluded that a component failure unrelated to design and manufacturing deficiencies contributed to the failure.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.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 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: 9819976
• MDR Text Key: 183351256
• Report Number: 1820334-2020-00589
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)230203(10)10304112
• 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,Followup
• Report Date: 03/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2023
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: 10304112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2020
• Date Manufacturer Received: 04/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1