MAUDE Adverse Event Report: COOK INC UNKNOWN; GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY

Model Number N/A

Device Problem Difficult to Remove (1528)

Patient Problem Pneumothorax (2012)

Event Type  Injury  

Event Description

It was reported that difficulty was encountered when removing unknown cook chest tube drains.The customer stated that there have been a few incidents when removing the drains have resulted in the patient getting a pneumothorax.They were interested in receiving further education on removal of the devices.Additional information regarding the event and patient outcome has been requested but is currently unavailable.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E3 - occupation: clinical nurse specialist.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 or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation.It was reported that unknown ultrathane mac-loc locking loop multipurpose drainage catheters were difficult to remove and resulted in a pneumothorax for several patients.The devices were placed for use as chest tubes.No other adverse events were reported.Additional information regarding the events and patient outcomes was requested but not provided.It should be noted that the facility stated instruction regarding device removal was not provided to the staff, and they requested education materials.Reviews of the complaint history, device history record (dhr), 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.The rpn was not provided.Based on limited information, cook concluded the device was of a ult product.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.A review of the device history record (dhr) was unable to be completed due to a lack of lot information.An expanded sales search to the customer was unable to identify the complaint lot.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook reviewed the product labeling for the complaint device.The instructions for use (ifu) [ t_multi2 rev1), multipurpose drainage catheter] states the following.How supplied: upon removal from package, inspect the product to ensure no damage has occurred.Intended use: multiple drainage catheters are intended for percutaneous drainage applications (e.G nephrostomy, biliary and abscess), either by direct stick or seldinger access technique.Warnings: if a catheter has become malposition or if drainage ceases, the catheter should be promptly exchanged or removed.References: these instructions for use are based on experience from physicians and (or) their published literature.Refer to your local cook sales representative for information on available literature.Based on the limited information provided, no device return, and the results of the investigation, cook medical has concluded that a root cause category cannot be established.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.

Event Description

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

• Brand Name: UNKNOWN
• Type of Device: GBO CATHETER, NEPHROSTOMY, GENERAL & PLASTIC SURGERY
• 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: 17266784
• MDR Text Key: 318548406
• Report Number: 1820334-2023-00869
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/27/2023
• Initial Date FDA Received: 07/06/2023
• Supplement Dates Manufacturer Received: 02/02/2024
• Supplement Dates FDA Received: 02/08/2024
• 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): Other