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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem Fluid Discharge (2686)

Event Date 04/03/2019

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 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 a cecostomy catheter placed vie wire guide exchange.The anatomic target location of the catheter was the appendix, in which glycerin and contrast used during the chait change procedure were instilled through the catheter for the duration of device placement.On (b)(6) 2019 (27 days post-procedure), the patient experienced stoma site leakage with abdominal distention/taughtness.An abdominal x-ray was performed.The patient received medical treatment with a golyfely cleanout and opsite bandage.This event was considered related to the study device and the site noted the device ¿keeps track open¿ as how the device caused/contributed to this event.The 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.

Event Description

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

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 that occurred on (b)(6) 2019 at (b)(6) hospital med.Ctr.(united states) involving a chait percutaneous cecostomy catheter (rpn: tdcs-100-m; lot: unknown).The customer stated that twenty-seven days post-procedure that patient experienced stoma site leakage.The customer stated that the event was considered not to be related device deficiency.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 steps 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.For tract lengths between 6 and 14 cm, see sizing recommendations for appropriate size.If cecostomy tract is greater that 14 cm, a multipurpose drainage catheter should be used.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 to confirm catheter position and patency within cecum.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, cook was not able to establish a cause for this event.It is possible that the device was not maintained properly by patient.It is possible patient anatomy was not compatible with the chait size.Patient activity could have led to leakage of the site.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.

• 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: 16755168
• MDR Text Key: 313719024
• Report Number: 1820334-2023-00450
• 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: 12 YR
• Patient Sex: Male
• Patient Weight: 30 KG