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

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Patient Device Interaction Problem (4001)

Patient Problems Cellulitis (1768); Fluid Discharge (2686)

Event Date 05/02/2019

Event Type  Injury  

Event Description

The patient underwent the removal and replacement of a previously placed cecostomy catheter.The previously placed catheter was replaced with a cook chait percutaneous cecostomy catheter on (b)(6) 2019.The percutaneous placement procedure was completed using fluoroscopy.The target anatomic location was the cecum.The placement of the cook chait percutaneous cecostomy catheter was considered successful.While the device was in place, saline and glycerin fluids were instilled in the catheter.Initial bowel evacuation was reported to be successful.No device deficiencies or adverse events were identified during the procedure.On (b)(6) 2019 (102 days post procedure), the patient experienced a stoma site infection.Leaking stool was causing cellulitis around the stoma site.The patient underwent surgical wound debridement.On (b)(6) 2019, the device was removed and replaced with a competitor's device.Additionally, the patient was hospitalized for "less than 24 hours" for the cellulitis of the stoma site.The infection was resolved.

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

Investigation ¿ evaluation.It was reported by (b)(6) hospital medical center ((b)(6)) via a post- market study(b)(4) that leakage and stoma infection occurred after placement of a chait percutaneous cecostomy catheter (rpn: tdcs-100-l; lot#: unknown).The device was required for treatment of fecal incontinence.On (b)(6) 2019, the patient had her previously placed cecostomy catheter exchanged for a cook cecostomy catheter.The new catheter was placed in the cecum during an image-guided percutaneous procedure.The placement and initial bowel evacuation were successful.Glycerin was instilled throughout the duration of the time the chait remained in place.On (b)(6) 2019, stoma site infection was identified, and wound debridement was performed.On (b)(6) 2019, the chait was removed and replaced with a competitor¿s device due to leaking stool causing cellulitis around the site.The patient was hospitalized for less than 24 hours.No other adverse events were reported due to this occurrence.The study site noted that the event was not considered to be related to the device nor the study procedure.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, no physical examination could be conducted.However, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that process steps were identified to ensure nonconforming material does not leave the house.A review of the device history record (dhr) was unable to be completed due to the lack of lot information available.Cook also reviewed product labeling.The instructions for use (ifu) [t_tdcs_rev7] supplied with the complaint rpn was reviewed for information related to the reported failure mode.The ifu states: ¿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¿ for tract lengths between 6 and 14 cm, see sizing recommendations for appropriate size.If cecostomy tract is greater than 14 cm, a multipurpose drainage catheter should be used¿¿ ¿patient instructions for maintenance of chait trapdoor cecostomy catheter note: instruct the patient to read and understand the patient guide titled ¿caring for your temporary & chait trapdoor cecostomy catheters¿ prior to initial catheter introduction¿ after use, patient should remove connecting tube and pin from trapdoor fitting, and close fitting to prevent leakage.¿ from a review of the dmr, no dhr, and with no product return, cook was not able to find evidence the product was manufactured out of specification.Cook was not able to determine evidence of any non-conforming material in house or in the field.Based on the information provided, no product returned, and the results of our investigation, a definitive cause for the failure could not be established.It is possible the patient did not maintain the device as described in the patient guide.It is possible the chait size and tract length was incorrect for the patient.It is reasonable the interaction of stool with the stoma contributed to the infection.The appropriate personnel have been notified.Per the risk assessment no further action is required.Cook 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.

Event Description

No additional information regarding patient and/or event details 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: 16710028
• MDR Text Key: 313007600
• Report Number: 1820334-2023-00397
• 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: Study,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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-L
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/28/2023
• Initial Date FDA Received: 04/10/2023
• Supplement Dates Manufacturer Received: 08/10/2023
• Supplement Dates FDA Received: 08/16/2023
• 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: 20 YR
• Patient Sex: Female
• Patient Weight: 90 KG