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 05/21/2019

Event Type  malfunction  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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 with a chait percutaneous cecostomy catheter.The device was required for a study procedure (mdr-2036) for treatment of fecal incontinence.On (b)(6) 2019, the patient had their previously placed cecostomy catheter exchanged for a cook cecostomy catheter.The new catheter was placed using an open surgical method into the target site, cecum.Saline and glycerin were instilled throughout the duration of time the cecostomy catheter remained in place.The placement procedure was successful and no deficiencies were identified during the procedure.The initial bowel evacuation was successful.On the same day, (b)(6) 2019, the patient experienced stoma site leakage.The patient also reported experiencing skin irritation, leaking, and granulation tissue that started during the first placed cecostomy catheter in 2018 and is still an ongoing issue.As a result, antibiotics were given.Kenalog and silver nitrate were applied to the granulation tissue and a dressing was applied around the site.No other adverse effects were reported for this incident.

Event Description

The indication for placement of the chait device was for fecal incontinence and severe, chronic constipation.The disease state responsible for the device placement were neurogenic fecal incontinence and spina bifida.

Manufacturer Narrative

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

Correction: this report is being sent to indicate the complaint event is not reportable.Upon further review, it was determined this event is not reportable under fda 21 cfr part 803 as it does not meet the criteria for a death, serious injury or reportable product malfunction.As reported, the patients experienced skin irritation, leaking, and granulation tissue after device placement which required antibiotics, kenalog, and silver nitrate treatment.No additional procedures were required.This is not considered intervention to preclude permanent impairment or death.Therefore, this event is no longer considered a serious injury per 21 cfr part 803.3.No device malfunction was reported.

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.Correction: b1, h1 investigation ¿ evaluation it was reported by (b)(6) medical center (cincinnati, usa) via a post- market study (mdr-2036) a chait percutaneous cecostomy catheter (rpn: tdcs-100-l; lot#: unknown) leaked.The device was required 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 chait cecostomy catheter.On the day of device placement, it was reported that the stoma site leaked.As a result, antibiotics were given.A topical corticosteroid and silver nitrate were applied to the granulation tissue, and a dressing was applied around the site.No other events were reported due to this occurrence.Reviews of the complaint history, quality control, and instructions for use (ifu), 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 that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) was unable to be completed due to a lack of lot information.An expanded sales search to the customer was unable to identify the complaint lot.Based on the available information, cook has concluded that there is no evidence the device was manufactured out of specification and there is no evidence suggesting nonconforming product exists either in house or in 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: contraindications previous abdominal surgical procedures.Precautions instruct the 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 coils will reform in the cecum.) 4.Perform contrast injection to confirm catheter position and patency within cecum.Based on the available information, no product returned, and the results of the investigation, cook determined the cause for this event is likely due to patient condition.It is possible the patient¿s past medical history led to this event.Past abdominal surgical history includes bladder augmentation and lysis of adhesions.It is possible that the adhesions from past abdominal surgeries placed tension on the device and contributed to the reported leakage.Several months prior to the placement of the chait device, the initial cecostomy device was placed.The patient reported leakage after placement of this device as well.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 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 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: 16776269
• MDR Text Key: 313651433
• Report Number: 1820334-2023-00469
• 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,Followup,Followup
• Report Date: 10/27/2023

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?: Yes
• 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: 09/29/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 22 YR
• Patient Sex: Male
• Patient Weight: 45 KG