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 Problem Difficult to Remove (1528)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Per the customers email: my colleagues reported to me this morning that they often have trouble with the product.They follow the steps in the video (colon decompression set 14 fr | cook medical) and lubricate the parts with water.The problem is when they get to step #10 to remove the guide and inner tube.The outer tube, which is very soft, sticks and comes back with the other parts.This always happens outside working hours.One nurse tells me it's at least the 3rd time it's happened to her, the 2nd nurse tells me it's the 2nd time it's malfunctioned.As for me, i've only used it once.The following information has been requested via email on 20jun2023.Sg 20jun2023." 1.Did any unintended section of the device remain inside the patient¿s body? a.If yes, please describe.2.Was the patient hospitalized or was there prolonged hospitalization? 3.Did the patient require any additional procedures due to this occurrence? 4.Did the product cause or contribute to the need for additional procedures? a.If yes, please specify additional procedures and provide details.5.Has the complainant reported any adverse effects on the patient due to this occurrence? 6.Has the complainant reported that the product caused or contributed to the adverse effects? a.Please specify adverse effects and provide details." the following information has been requested via email on 20jun2023.Sg 20jun2023.Was the device flushed before use? yes.What was flushed through the device (water, saline, etc.)? water.The following information has been requested via email on 20jun2023.Sg 20jun2023.24.How was the procedure able to be completed? 25.Was lubrication applied to the decompression tube? 26.Details of the wire guide used (diameter, type, make)? a.If not with the device in question, how was the procedure finished? 27.Please advise the anatomical location of the intended target site.28.How experienced was the physician with using the cdsg? 29.What intervention (if any) was required? 30.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day 31.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? a.If yes, please specify what was observed and where on the device it was observed.32.What is the endoscope manufacturer and model number that was used? 33.Was resistance encountered when advancing the decompression tube into position? a.If resistance was encountered, was the endoscope withdrawn a short distance? 34.How often was the decompression tube irrigated? 35.Did any section of the device detach inside the endoscope or patient? 36.How long was the set left in dwelling?.

Manufacturer Narrative

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

Manufacturer Narrative

Pma/510(k) #k171619.Device evaluation 6 x cdsg-14-175 devices of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.This file is related to (b)(4) - negative feedback.Lab evaluation the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.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.To verify the integrity of the catheter tubing, fqc checks outlined instruct the operator to: 12.1.Verify wire guide size before each use, ensure that the wire guide can be passed through the product from distal end through to the proximal end of the product.Remove the wire guide back out the proximal end of the product.Refer to drawing.12.2.Measure full length of catheter; refer to drawing.It is at this stage of the process that any defects observed on the catheter tubing would be identified before the device is released from cirl.The instructions for use, ifu0102, 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 (ifu0102).Image review an image was not returned for evaluation.Root cause review a definitive root cause could not be determined.As there is limited information provided in the file pertaining to the events, a root cause can only be speculated.A possible root cause can be attributed to 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 and subsequently causing issue reported ¿sticks and comes back with the other parts.¿ confirmation of complaint complaint is confirmed based on customer and/or rep testimony.Summary complaint is confirmed based on customer and/or rep testimony.Failure identified: unable to remove wire guide and guiding catheter leaving colon decompression tube in position., 06 devices confirmed used.A definitive root cause could not be determined.As there is limited information provided in the file pertaining to the events, a root cause can only be speculated.A possible root cause can be attributed to 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 and subsequently causing issue reported ¿sticks and comes back with the other parts¿ according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.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 01-dec-2023.

• 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: 17336403
• MDR Text Key: 319496812
• Report Number: 3001845648-2023-00556
• Device Sequence Number: 1
• Product Code: FEG
• Combination Product (y/n): N
• 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: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2023
• 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
• Event Location: Hospital
• Date Manufacturer Received: 06/20/2023
• 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