MAUDE Adverse Event Report: COOK INC ULTRATHANE RING BILIARY DUCT DRAINAGE CATHETER; FGE CATHETER, BILIARY, DIAGNOSTIC

Model Number N/A

Device Problems Improper or Incorrect Procedure or Method (2017); Obstruction of Flow (2423)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

Common device name: lje catheter, nephrostomy; gbo catheter, nephrostomy, general & plastic surgery.Additional product codes: lje, gbo.Initial reporter phone number: (b)(6).Initial reporter occupation: assistant manager.Pma/510(k) #: k173035.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 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

It was reported the flexible stiffening cannula of an ultrathane ring biliary duct drainage catheter was retained in a patient.The device was placed in the patient during a "pdbd" procedure.Following the procedure, poor drainage was noted.It was then discovered the flexible stiffener was still inside the catheter.As a result, the patient required an additional procedure in interventional radiology where the stiffening cannula and catheter were removed and the drain was replaced.No other adverse effects were reported for this incident.

Event Description

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

Manufacturer Narrative

Investigation ¿ evaluation: it was reported by a (b)(6) hospital (hong kong) on 28sep2022 that the stiffening cannula was left in an ultrathane ring biliary duct drainage catheter (rpn: ult8.5-38-50-p-32s-ring; lot#: unknown).The device was required for a percutaneous biliary drainage (pdbd) procedure.After completion of the procedure, drainage was insufficient.The catheter was investigated, and it was discovered that the stiffening cannula was retained inside the drain.The patient then required an additional procedure in interventional radiology to remove the catheter and stiffening cannula and to replace the drain.No other adverse effects were reported for this incident.Reviews of the instructions for use (ifu) and quality control procedures for the device were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook could not review the device history record (dhr) due to lack of lot information from the user facility.Review of the sales records to the user facility over three years prior to the date of event could not sufficiently narrow down the lot number.Cook also reviewed product labeling.Instructions for use (ifu) document t_multi2_rev1 [multipurpose drainage catheter] is packaged with this device.The ifu contains the following instructions relevant to this failure mode: catheter placement 2.Once catheter is in desired location, remove any wire guides, trocars, or stiffeners, allowing the catheter to form its configuration.The information provided upon review of the ifu suggests that the device was not manufactured out of specification, and that there are no nonconforming devices in house or out in the field.Based on the information provided, no returned device, and the results of the investigation, cook has concluded failure to follow ifu instructions by not removing the stiffening cannula contributed to this incident.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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 RING BILIARY DUCT DRAINAGE CATHETER
• Type of Device: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 15837404
• MDR Text Key: 304093838
• Report Number: 1820334-2022-01756
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ULT8.5-38-50-P-32S-RING
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention