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

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problem Fluid Discharge (2686)

Event Date 06/19/2019

Event Type  malfunction  

Event Description

It was reported there was an incident involving 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 their previously placed cecostomy catheter exchanged for a cook cecostomy catheter.The new catheter was placed using a package stylet in the clinic.The target anatomic location was the appendix.Saline and glycerin were instilled throughout the duration of time the cecostomy catheter remained in place.On (b)(6) 2019 (140 days post-procedure), the patient experienced formed fecal matter coming out around the chait catheter.The patient was given medical advice to increase the frequency and strength when flushing the cecostomy catheter.It was noted the patient had missed some flushes prior to this event.This event was considered related to the study device.The site noted the device "keeps channel open" as how the device caused/contributed to this event and dysmotility as a pre-existing condition that caused/contributed to this event.This event was not considered to be related to the study procedure nor due to a device deficiency.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 or unavailable.Common device name: additional names: exd irrigator, ostomy.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.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation: evaluation.On 06apr2023, cook became aware of an event on 19jun2019 at (b)(6) medical center (united states) involving a chait percutaneous cecostomy catheter (rpn: tdcs-100-m; lot unknown).The customer stated that one hundred- and forty-days post-procedure the patient experienced formed fecal matter coming out around the chait catheter.The customer stated that the patients pre-existing condition of dysmotility caused or contributed to this event.It was reported the patient had missed some flushes prior to the event.Treatment included increasing chait flush and frequency and strength.It was indicated that the device was not removed or exchanged prior to six months post-procedure.Reviews of documentation including the complaint history, instructions for use (ifu), and quality control procedures of the complaint 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.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.Based on this information, the device was manufactured to specification.There is no evidence of nonconforming material in house or in the field.Cook also reviewed product labeling.The ifu, 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.How supplied: upon removal from package, inspect the product to ensure no damage has occurred.Based on the information provided, no product returned, and the results of the investigation, the main cause for this event was determined to be due to patient user error.The patient was not flushing and caring for the device as stated in the patient guide.The customer statement that the patient had been missing flushing routine which could lead to this event.However, none of these possibilities can be confirmed without additional information.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: 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: 16755719
• MDR Text Key: 313495126
• Report Number: 1820334-2023-00451
• 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: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2023
• 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-M
• 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: 10 YR
• Patient Sex: Male
• Patient Weight: 41 KG