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 Problems Difficult to Remove (1528); Difficult to Advance (2920)

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

Event Date 11/12/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: unknown.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 an unknown patient required placement of an ultrathane mac-loc locking loop biliary drainage catheter for a percutaneous biliary drainage procedure.After flushing of the catheter and the introducer, the operator noticed the introducer did not "advance fully" through the catheter.The operator noted "the introducer got stuck within the catheter." the device was replaced with another device of a different lot and a "similar situation" occurred.The second device was used to complete the procedure, but "with some difficulty".As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.The first device is recorded under the medwatch report with patient identifier (b)(6).The second device is recorded under the medwatch report with patient identifier (b)(6)(this report).

Manufacturer Narrative

Additional methods code: historical data analysis (4109).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, were conducted during the investigation.The complaint device was not returned to cook for investigation.Due to this, no dimensional, visual, or functional verifications could be completed.However, a document based investigation evaluation was performed.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 history record (dhr) for complaint lot and relevant subassemblies revealed three reported nonconformances relevant to the reported failure mode.All nonconforming product were scrapped, and the device goes through a 100% inspection for the recorded nonconformances, thus there is no evidence suggesting nonconforming product in house.A database search revealed no other complaints have been reported for the device lot, therefore there is no evidence suggesting that nonconforming product from this lot exists in the field.The device is shipped with instruction for use (ifu) for a ¿multipurpose drainage catheter¿ and provides the following information to the user related to the reported failure mode: precautions: ¿when inserting a stiffening cannula into a catheter with retention suture, hold suture during cannula insertion to avoid bunching or tangling of suture.¿ how supplied: ¿supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not upset he product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, no returned product and the results of the investigation, it was concluded that component failure without a manufacturing or design defect contributed to the failure mode.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: 9374889
• MDR Text Key: 177134669
• Report Number: 1820334-2019-02951
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)220826(10)9971682
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: 9971682
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1