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 Difficult to Remove (1528)

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

Event Date 09/12/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: quality engineer.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 a ultrathane mac-loc locking loop biliary drainage catheter for a drainage procedure.After "insertion of the needle and drainage catheter" in the target location, the operator noticed "the needle could not withdrew [sic] from the cannula".The user removed the device and replaced it 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.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown or unavailable.Product received on: (b)(6) 2019.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.One catheter and metal cannula was returned for investigation.Physical examination of the returned device showed the cannula lodged in the tip of the catheter, but not protruding out.No visible damage to the catheter was noted.An attempt to remove the cannula resulted in catheter distal tip according.The distal tip of the catheter was relaxed, and the cannula was able to be removed.The metal cannula was found to be bent at 4 cm from the hub.Biomatter was noted on the cannula, potentially contributing to the removal difficulty.Dimensions deemed relevant to the reported failure mode were analyzed and determined that the device was manufactured within specification.Additionally, a document based investigation evaluation as performed.The risk specifications covering mac-loc drainage catheters include difficult inserting/removing the metal stiffener into the catheter and damage to the catheter during introduction of the metal stiffening cannula.The identified risk control includes the 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.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is shipped with instruction for use (ifu) which notes: how supplied: "upon removal from package, inspect the product to ensure no damage has occurred.¿ a review of the device history record for this lot number and relevant subassemblies revealed one non-conformance relevant to the reported failure mode.However, there is 100% inspection for this prior to lot release and all identified devices were scrapped out.It should be noted that there were no other complaints reported for this device lot number.There is no evidence suggesting that nonconforming product from the reported or additional lots exists in house or in the field.Based on the information provided, the examination of returned product and the results of the investigation, a definitive cause could not be established.Appropriate measures have been taken to address this failure mode.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.

• 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: 9135667
• MDR Text Key: 176664001
• Report Number: 1820334-2019-02458
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)220529(10)9771822
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/29/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: 9771822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Initial Date Manufacturer Received: 09/27/2019
• Initial Date FDA Received: 09/30/2019
• Supplement Dates Manufacturer Received: 11/22/2019
• Supplement Dates FDA Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 72