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 Skin Erosion (2075); Fluid Discharge (2686)

Event Date 09/27/2019

Event Type  malfunction  

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.

Event Description

T was reported that a chait percutaneous cecostomy catheter leaked.The device was required for a study procedure (mdr-2036) for treatment of fecal incontinence, severe chronic constipation, and imperforate anus and was placed on (b)(6) 2019.The device was placed in the appendix laparoscopically and glycerin was instilled.The initial bowel evacuation was successful.On (b)(6) 2019, leakage and skin excoriation at the catheter site were discovered.Wound care was performed, and an absorbent foam dressing was applied to area.The patient was provided instructions for home care.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.

Event Description

No additional information regarding patient and/or event details 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.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

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

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation a representative of (b)(6).(united states) contacted cook on (b)(6) 2023 with a complaint concerning a chait percutaneous cecostomy catheter (rpn: tdcs-100-m device, lot: unknown).The device was placed successfully on (b)(6) 2019 with no adverse effects.Thirty-two days post procedure (b)(6) 2019), the patient developed skin excoriation at the catheter site.The patient¿s mother also reported leaking at the chait site with skin irritation, which was treated with mepilex dressing at site of skin breakdown along with patient instruction for home use.The site investigator determined the event related to the study device and noted, ¿catheter caused pressure and subsequent skin breakdown.¿ the event was not considered to be related to the study procedure.The site indicated that the event did not occur due to a device deficiency.The device was explanted during a routine exchange on 01may2020.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, a physical examination could not be conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) identified process steps in place to ensure that nonconforming material does not leave the house.A review of the device history record (dhr) could not be conducted due to the lack of lot information.Cook was not able to find evidence the product was manufactured out of specification, or that nonconforming material exists in house or in the field.Cook also reviewed product labeling.This product is supplied with an instructions for use (ifu) pamphlet, t_tdcs_rev7.In the precautions section it states: instruct patient to read and understand the patient guide titled ¿caring for your temporary & chait trapdoor cecostomy catheters¿ prior to initial catheter introduction.The catheter should be changed every 6 months to reduce the risk of catheter fracture in the patient.In the pre-placement recommendations section, it states: note: instruct the patient to flush the temporary drainage catheter twice daily using a 10 cc syringe and 10 ml of water.This catheter flushing procedure and a normal rectal enema regimen should be continued for one week before initiating antegrade cecostomy enemas.Note: after appropriate tract maturation, the temporary drainage catheter should be removed and replaced with the chait trapdoor cecostomy catheter.(this will be approximately 6 weeks after initial procedure).In the how supplied section it states: upon removal from package, inspect the product to ensure no damage has occurred.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 the product was too large for the patient.It is also possible that the product was not maintained according to provided product labeling; but this cannot be confirmed.The appropriate personnel have been notified.Per the risk assessment no further action is required.We 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.

• 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: 16708820
• MDR Text Key: 313217648
• Report Number: 1820334-2023-00391
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/20/2023
• Initial Date FDA Received: 04/10/2023
• Supplement Dates Manufacturer Received: 04/03/2023; 06/13/2023
• Supplement Dates FDA Received: 05/01/2023; 06/30/2023
• 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: 4 YR
• Patient Sex: Male
• Patient Weight: 28 KG