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 10/31/2019

Event Type  malfunction  

Manufacturer Narrative

Occupation: unknown.Initial reporter also sent report to fda: unknown.Pma/510(k) #: preamendment.Investigation ¿ evaluation.A review of the complaint history, device history record, drawing, instructions for use (ifu), quality control, and specifications of the device, as well as a visual inspection, functional test, and dimensional verification, were conducted during the investigation.The complainant returned on catheter and flexible stiffener for investigation.Physical examination of the returned device showed the flexible stiffener inserted in the catheter and biomatter on the exterior of the device.The flexible stiffener was found to be advanced all the way to the distal tip of the catheter, but was extending from the mac-loc hub.The flexible stiffener was able to be removed by relaxing the distal tip of the catheter, and found multiple sections of elongation.All dimensions deemed relevant to the reported failure were analyzed (flexible stiffener od, catheter id), and confirmed that the device was manufactured within specification.Additionally, a document-based investigation evaluation was performed.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device history record (dhr) for the complaint lot, catheter tubing subassemblies, and flexible stiffener raw material lots revealed no related nonconformances.A database search for complaints on the reported lot found no additional complaints reported from the field.At this time, there is no evidence suggesting that nonconforming product from this lot exists in house or in the field.Product labeling was also reviewed.The product instructions for use (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.¿ based on the information provided, visual inspection of the returned product, and the results of the document investigation, cook has concluded that a component failure without a manufacturing or design defect contributed to this incident.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.

Event Description

As reported, an unknown patient required the placement of an ultrathane mac-loc locking loop biliary drainage catheter for an unknown procedure.The operator reported that during the procedure, "they could not get the stylet to progress through the catheter and it would get stuck." the same failure was noted with another device of the same lot.The device was returned with the flexible stiffener advanced in the catheter, and could only be removed by relaxing the distal tip of the catheter.Examination of returned product also noted multiple sections of elongation of the flexible stiffener.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

• 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
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jennifer canada ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 9667263
• MDR Text Key: 177843695
• Report Number: 1820334-2020-00284
• Device Sequence Number: 1
• Product Code: GCA
• UDI-Device Identifier: 00827002094970
• UDI-Public: (01)00827002094970(17)220715(10)9879095
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/15/2022
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-40-P-32S-CLB-RH
• Device Lot Number: 9879095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Date Manufacturer Received: 01/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1