MAUDE Adverse Event Report: COOK IRELAND LTD COLON DECOMPRESSION SET; FEG TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

Catalog Number CDSG-14-175

Device Problems Difficult to Remove (1528); No Apparent Adverse Event (3189)

Patient Problem Insufficient Information (4580)

Event Date 10/26/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Pma/510(k) #: k171619.

Event Description

Nurses complained that it has been difficult to remove the wire from the colon decompression tube following placement in a patient.They said this has happened with this product many times.The rep advised that they have not been reported before as it was reported to her for the first time yesterday (pr: (b)(6)) and the customer said that it happens all the time with this product.She asked the customer how many times it has happened and they said it happens most times they used it but could not give me an exact number.Note: csd requested information on how many times it occurred (including the dates), if they have been reported to csd in the past, the lot numbers involved, and the patient outcome for each of the occurrence.Jil01: on (b)(6) 22.Reply from the rep was received on 28/10/22 jil01: they said that it happens 5 times per year (pr: (b)(6)), but they do not have the dates of occurrences, the lot numbers involved, or the patient outcome for these past occurrences.Facility does not have patient outcome details for these past occurrences.

Manufacturer Narrative

Pma/510(k) # k171619.Device evaluation: the cdsg-14-175 device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.This complaint was logged to address difficulty removing the wire guide from the device.The events cannot be investigated separately as the facility did not provide further detail and facility does not have patient outcome details for these past occurrences.Document review: manufacturing records review could not be completed as the lot number is unknown.However, prior to distribution all cdsg-14-175 devices are subject to visual a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.Review of historical data: historical data was not reviewed as the lot number is unknown.The instructions for use states the following: ¿visually inspect the packaging and device.If the packaging is opened or damaged when received, do not use.If a device abnormality is detected that would prohibit proper working condition, do not use." there is no evidence to suggest the user did not follow the ifu.Root cause review: a definitive root cause could not be determined.A possible root cause can be attributed the position of the colonoscope during device placement.It¿s possible that the if the colonoscope was in a flexed position during placement of the device it may have caused or contributed to difficulty when removing the wire guide/guiding catheter to leave the decompression tube in place.It¿s also possible that a difficult/tortuous patient anatomy may have exerted extrinsic force on the device during placement and/or removal of the wire guide/guiding catheter.This force may have caused and/or contributed to compression of the device resulting in the decompression tube becoming stuck on the wire guide and/or the user experiencing difficulty in removing the wire guide and guiding catheter.Summary: complaint is confirmed based on customer and/or rep testimony.A possible root cause is attributed to difficult patient anatomy.It is not possible to determine if the patient experienced any adverse effects due to these occurrences.The facility does not have patient outcome details for these past occurrences.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 18-jan-23.

• Brand Name: COLON DECOMPRESSION SET
• Type of Device: FEG TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 15851795
• MDR Text Key: 307995454
• Report Number: 3001845648-2022-00798
• Device Sequence Number: 1
• Product Code: FEG
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CDSG-14-175
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/26/2022
• Event Location: Hospital
• Date Manufacturer Received: 10/27/2022
• 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