|
A2 - age at the time of study procedure (placement of chait trapdoor cecostomy catheter): 17 years old.A4 - weight at time of study procedure (placement of chait trapdoor cecostomy catheter): 51 kg.D2a ¿ common name: exd irrigator, ostom.D2b ¿ product code: 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.
|
|
It was reported a chait percutaneous cecostomy catheter leaked.The device was required for a study procedure (mdr-2036) for treatment of fecal incontinence and severe, chronic constipation.On (b)(6) 2020, a female patient had an initial placement of a cecostomy catheter into the appendix via ¿dilated up of skin using guidewire and dilators¿ as well as fluoroscopy and ultrasound for imaging during the placement.The placement of the cecostomy catheter was considered successful.Saline, castile soap, and glycerin were instilled throughout the duration of time the cecostomy catheter remained in place.The initial evacuation of the bowel was successful.No device deficiencies or adverse events were identified during the procedure.On (b)(6) 2020 (54 days post-procedure), the patient experienced skin excoriation at the catheter site, stoma site pain, and stoma site leakage.The site has not yet provided their assessment of event relationship or event severity.On (b)(6) 2020, device was removed 59 days post procedure due to pain, leakage, and bleeding.Skin excoriation at the catheter site was also identified.No other adverse effects were reported for this incident.
|
|
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.
|
|
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation ¿ evaluation.On (b)(6) 2023, cook became aware of an incident at children's hospital med.Ctr.(united states) involving the leakage of a chait percutaneous cecostomy catheter (rpn: tdcs-100-m; lot: unknown).The device was required for a study procedure (b)(6) for treatment of fecal incontinence and severe, chronic constipation.On (b)(6) 2020, a female patient had a successful initial placement of a cecostomy catheter into the appendix.The patient experienced skin excoriation at the catheter site, stoma site pain and stoma site leakage fifty-four days post procedure.On (b)(6) 2022, the device was removed fifty-nine days post procedure due to pain, leakage, and bleeding.The customer indicated that the event of skin excoriation at the catheter site was due to a tight fit of the device.The customer stated that more size options are needed not just the three offered.This event was not considered to be related to the procedure or to be due to a device deficiency.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.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.Instructions for use: 2.) carefully pull catheter out over pre-positioned wire guide (e.G., amplatz ultra stiff).Determine cecostomy tract length and place appropriately sized catheter.Note: confirm that tract is appropriate length to accommodate chait trapdoor cecostomy catheter by advancing wire guide, under fluoroscopy, until tip is within cecum and then clamping hemostat at skin level.Withdraw wire guide, and measure distance from hemostat to wire guide tip.Based on the information provided, no product returned, and the results of the investigation, the cause for this event could not be established nor could manufacturing deficiencies be determined.It is possible the sizing of the catheter used was a factor.It is also possible the device was not maintained correctly.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.
|
