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

Model Number N/A

Device Problem Leak/Splash (1354)

Patient Problems Abdominal Pain (1685); Feeding Problem (1850); Abdominal Distention (2601); Fluid Discharge (2686); Constipation (3274)

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 via a post market study (b)(6) that a chait percutaneous cecostomy catheter leaked.On (b)(6) 2019, a 12-year-old male patient patient underwent placement of a chait percutaneous cecostomy catheter via guidewire exchange.The target anatomic location was the appendix.Saline and glycerin were instilled throughout the duration of time the catheter remained in place.On (b)(6) 2019 (27 days post-procedure), at the 30-day post-procedure follow-up, the site reported that the patient did not experience improvement of symptoms after device placement.The patient experienced stoma site leakage, abdominal distention, and an intolerance to tube feedings due to feeling full.As a result, the patient required an abdominal x-ray which showed impaction.Additionally, polyethylene glycolelectrolyte solution cleanout was administered, and a transparent adhesive bandage was applied to the site.It should also be noted, the site reported that the patient had history of not following routine treatment plans.On (b)(6) 2019 (32 days post-procedure), it was reported the patient experienced abdominal pain and required an abdominal x-ray and a polyethylene glycolelectrolyte solution cleanout.On (b)(6) 2020, it was reported that the patient had a large stool burden per an abdominal x-ray and a "fecal mass" palpated on exam.Treatment included continuation of saline, glycerin, castile flushes, and the addition of a bisacodyl crushed pill.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation: on 03apr2023, cook became aware of an event on 03apr2019 at (b)(6) hospital med.Ctr.(united states) involving a chait percutaneous cecostomy catheter (rpn: tdcs-100-m; lot: unknown).It was reported that at thirty-day post procedure the patient did not experience improvement of symptoms.It was also noted at this time that leaking was occurring causing impaction noted on x-ray.The patient also experienced ongoing abdominal distention/tautness.The customer noted that the patient has a history of not following routine treatment plan.It was noted that the device was not 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) concluded sufficient inspection activities are in place to identify this failure mode prior to distribution.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 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.How supplied: upon removal from package, inspect the product to ensure no damage has occurred.Patient instructions for maintenance of chait trapdoor cecostomy catheter: 2.) instruct patient to administer a phosphate enema through the connecting tube attached to the chait trapdoor cecostomy catheter.3.) fifteen minutes after initiating infusion of the phosphate enema, patient should attach a saline enema via a gravity bag to complete the enema.4.) patient should continue saline antegrade enema until bowel drainage becomes clear.(usual saline volume is 200-500 ml.) after use, patient should remove connecting tube and pin from trapdoor fitting, and close fitting to prevent leakage.Note: post-procedural orders for patient should include a high-fiber diet and a decrease in consumption of constipating foods.Based on the information provided, no product returned, and the results of the investigation, the likely main cause for this event is non-compliance to the prescribed regimen for flushing complicated by the patients pre-existing conditions; however, cook was not able to establish a definitive cause for this event.It is noted that the patient was not following the outlined routine treatment plan, which would lead to this event.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: 16752403
• MDR Text Key: 313620113
• Report Number: 1820334-2023-00441
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2023

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: 08/01/2023
• 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