MAUDE Adverse Event Report: COOK INC CHAIT PERCUTANEOUS CECOSTOMY CATHETER; KNT TUBES, GASTROINTESTINAL

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problems Fluid Discharge (2686); Skin Inflammation/ Irritation (4545)

Event Date 09/01/2019

Event Type  malfunction  

Manufacturer Narrative

D2a - common device name: additional names: exd irrigator, ostomy.D2b - procode: additional product codes: exd.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.

Event Description

It was reported that there was an incident with a chait percutaneous cecostomy catheter.The device was required for a study procedure (mdr-2036) for treatment of fecal incontinence and severe, chronic constipation.On (b)(6) 2019, the patient had his previously placed cecostomy catheter exchanged for a cook cecostomy catheter.The new catheter was placed with the use of a packaged stylet into the appendix in the clinic.Water and glycerin were instilled throughout the duration of time the cecostomy catheter remained in place.On (b)(6) 2019 (142 days post-procedure), the patient experienced stoma site leakage and skin excoriation at the catheter site.These events were considered related to the device.The site noted, the device was "used to the keep channel open" as how the device caused/contributed to both events.These events were not considered to be related to the study procedure nor due to a device deficiency.Outcome of the event was not available.It was indicated that the device had not been removed prior to 6-months post-procedure.As reported, the patient did not experience any serious injuries or require any additional procedures due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation.On (b)(6) 2019, (b)(6).Ctr.(united states) had an event involving a chait percutaneous cecostomy catheter (rpn: tdcs-100 device, lot: unknown).The customer stated that the patient experienced stoma site leakage 142 days post-procedure.The same day, the patient experienced excoriation at the catheter site.As reported, the patient did not experience any serious injuries or require any additional procedures due to this occurrence.Reviews of the documentation, including the complaint history, instructions for use (ifu) and quality control procedures of the device, were conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examination could be conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) identified process step to ensure that nonconforming material does not leave the house.The customer did not provide the lot number for the complaint device.Cook reviewed the sales history for this customer and was unable to identify the complaint lot.The device history record could not be reviewed.Cook also reviewed product labeling.The instructions for use (ifu) pamphlet, t_tdcs_rev7, packaged with the device contains the following in relation to the reported failure mode: precautions: instruct patient to read and understand the patient guide titled ¿caring for your temporary & chait trapdoor cecostomy catheters¿ prior to initial catheter introduction.Instructions for use: 3.) insert metal stiffener into catheter to straighten coils, and push catheter through tract over pre-positioned wire guide.Once catheter is inserted, remove wire guide and metal stiffener until trapdoor is flush against the access site.(when stiffener and wire guide are removed, the extra catheter coils will reform in the cecum.) 4.) perform contrast injection to confirm catheter position and patency within cecum.How supplied: upon removal from package, inspect the product to ensure no damage has occurred.With a review of the dmr and no device return, cook was not able to find evidence the product was manufactured out of specification or of any nonconforming material in house or in the field.Based on the information provided, no returned product, and the results of our investigation, a definitive cause for the failure could not be established.It is possible that improper caring of the chait could lead to this event.It is possible that the chait used was not appropriate sizing for the patient.It is also possible that the catheter was incompatible with the patient's anatomy.However, none of these possibilities can be confirmed without additional information.The appropriate personnel have been notified.Per the 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 patient and/or event details has been received since the previous medwatch report was sent.

• Brand Name: CHAIT PERCUTANEOUS CECOSTOMY CATHETER
• Type of Device: KNT TUBES, GASTROINTESTINAL
• 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: 16781725
• MDR Text Key: 313724510
• Report Number: 1820334-2023-00476
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982500
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Study,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• 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: TDCS-100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/09/2023
• 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 Age: 27 YR
• Patient Sex: Male