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 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 operator tried to place an ultrathane mac-loc locking loop biliary drainage catheter for biliary drainage.The user reported difficulty advancing the blue stiffener into the catheter and then described elongation of the stiffener upon removal.This report is to capture an unknown number of previously unreported events with this failure mode.No other adverse effects were reported for this incident.

Manufacturer Narrative

Investigation ¿ evaluation.Amphia zkh loc.Molengracht informed cook of an incident involving a ultrathane mac-loc locking loop biliary drainage catheter from an unknown lot number.The blue stiffener was difficult to remove, and when it was removed it was found elongated.The device was exchanged for another, and the procedure was completed with no reported adverse effects.This complaint was captured in medwatch report #1820334-2020-00271.Cook was informed that the events that happened before were not reported.This complaint is to capture the previously unreported events.A review of the drawing, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device, were conducted during the investigation.The complainant did not return the complaint device; therefore, no physical examinations could be performed.However, this facility returned the same product experiencing the same failure mode associate with medwatch report #1820334-2020-00271.The physical examination of that device found the blue flexible stiffener was inserted into the catheter with 9.3cm extending from the hub.The exposed section of the blue stiffener was kinked in several places; however, the catheter was not damage.The blue stiffener was able to be removed, with no additional damage noted.An attempt was made to insert the stiffener, but it did not advance all the way into the tip.Dimensions deemed relevant to the reported failure mode were measured and were to specification.Additionally, 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 customer did not provide a lot number for investigation.A search of all lots sold to the reporting customer for the reported rpn over the timeframe 01jan2017 ¿ 27jan2020 could not specify the affected lot.Due to this, a device history record review could not be completed, and a database search for complaints on the affected lot could not be completed.At this time, there is no evidence suggesting that nonconforming product from the affected lot exists in house or in the field.The product ifu 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.¿ a capa has been opened to address this issue and is currently undergoing investigation.Based on the information provided, no inspection of returned product, and the results of the investigation, a definitive cause could not be established.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: 9744484
• MDR Text Key: 183158314
• Report Number: 1820334-2020-00422
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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?: No
• Date Manufacturer Received: 04/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1