MAUDE Adverse Event Report: COOK INC UNKNOWN

Model Number N/A

Device Problems Difficult to Remove (1528); Material Deformation (2976)

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

Event Date 08/30/2020

Event Type  malfunction  

Manufacturer Narrative

Suspect medical device: unspecified ultrathane mac-loc locking loop drainage catheter.Product code: exact device identity is not known.Likely product codes are: lje, fge, and/or gbo.Occupation: unknown.Pma/510(k) #: exact device identity is not known.Likely: exempt or k173035.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 unspecified ultrathane mac-loc locking loop drainage catheter for an unknown procedure.During the procedure, the dilator was difficult to remove and the catheter kinked and accordioned.Another device was used to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Additional information: b5 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

Additional information provided 21oct2020 stated the difficulty was experienced with the flexible stiffener.

Event Description

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

Manufacturer Narrative

Investigation ¿ evaluation.Rochester general hospital (united states) informed cook that the flexible stiffener in an unknown ultrathane mac-loc locking loop biliary drainage catheter was difficult to remove from the catheter.The facility reported that the catheter "accordioned" when the user tried to remove the stiffener during the procedure.Another catheter was used to complete the procedure.A review of the complaint history, instructions for use (ifu), manufacturing instructions, and quality control of the device was conducted during the investigation.The device was not returned for evaluation.A document based investigation evaluation was performed.A review of the device master record found that proper procedures are in place to identify and prevent this failure mode prior to device distribution.A review of the design history file found that risk mitigation controls are in place relevant to the failure mode.A review of the device history record could not be completed due to a lack of lot information from the user facility.There is no evidence to suggest there is any nonconforming product in house or out in the field.Additionally, a review of the product labeling for the device was completed.The instructions for use state the following instructions 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 use the 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 and the results of the investigation, a definitive cause for the failure was traced to component failure without a design or manufacturing issue.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.

• Brand Name: UNKNOWN
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10680945
• MDR Text Key: 213444660
• Report Number: 1820334-2020-01864
• Device Sequence Number: 1
• Product Code: GBO
• 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: 01/29/2021

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 Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/08/2020
• Initial Date FDA Received: 10/14/2020
• Supplement Dates Manufacturer Received: 10/21/2020; 01/11/2021
• Supplement Dates FDA Received: 11/03/2020; 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR