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

Model Number N/A

Device Problem Failure to Advance (2524)

Patient Problems Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 05/01/2020

Event Type  Injury  

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 that a chait percutaneous cecostomy catheter could not be placed.On (b)(6) 2020, a 4-year-old male patient was scheduled for an exchange of a chait percutaneous cecostomy catheter; however, the physician was unable to pass the new device into the tract.As result, on (b)(6) 2020, the patient required a malone rescue procedure in interventional radiology, and a new chait device was placed.It was reported the patient experienced pain and site bleeding.No other adverse effects were reported for this incident.

Manufacturer Narrative

Investigation ¿ evaluation: it was reported by a representative of (b)(6) medical center (cincinnati, usa) that a chait percutaneous cecostomy catheter (rpn: tdcs-100-m; lot#: unknown) could not be placed.On (b)(6) 2020, the patient was scheduled for an exchange of a previously placed chait percutaneous cecostomy catheter of the same size.The new chait was to be placed in the appendix; however, the physician was unable to pass the new device into the tract.As result, on (b)(6) 2020, the patient required a malone rescue procedure in interventional radiology to save the appendicostomy site.A new chait device was placed at that time.It was reported the patient experienced pain and site bleeding.No other adverse effects were reported for this incident.Reviews of documentation including the complaint history, quality control procedures, and instructions for use (ifu) 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: contraindications: previous abdominal surgical procedures.Catheter exchange: 2.) remove catheter, leaving wire guide in place.Note: if stiffening cannula was used for wire guide placement, remove stiffening cannula prior to catheter removal.3.) introduce new chait trapdoor cecostomy catheter over wire guide and advance into position.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 concluded there was no problem with the device.It is possible the patient¿s pre-existing conditions and anatomy could have led 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: 16752107
• MDR Text Key: 313416900
• Report Number: 1820334-2023-00440
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

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?: 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: 09/15/2023
• 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: 4 YR
• Patient Sex: Male
• Patient Weight: 28 KG