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

Model Number	G22181
Medical Device Problem Codes	Break (1069); Dent in Material (2526)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Description of event: as initially reported to customer relations: a patient of undisclosed gender and age underwent an unspecified procedure in which the colon compression set, g22181, was used.When the tube was placed, staff tried to take out inner tube (black tube plus wire) it kinked on the inside and broke into two pieces.The procedure was completed using a different set.
Additional Manufacturer Narrative
Device evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.There was no device present in the packaging returned only a completed product returned form and the customer subsequently confirmed that the complaint device had been discarded.Manufacturing records: prior to distribution, all cdsg-14-175 devices are subjected to functional checks and visual inspection to ensure device integrity.A nc (non-conformance) was noted in production where the device was damaged by the manufacturing operator but this device was scrapped and did not contribute to the reported issue.A review of the manufacturing records for cdsg-14-175 device of lot number c2142988 did not reveal any discrepancies that could have contributed to this complaint issue.Review historical data: a review of the manufacturing records for the cdsg-14-175 device confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c2142988.Instructions for use and label: the instructions for use, ifu0102, states the following under step 9: ¿once colon decompression tube is advanced to target area, under periodic fluoroscopic monitoring withdraw both guiding catheter and wire guide, making certain the colon decompression tube remains stationary within colon." 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 analysis: a definitive root cause could not be determined due to limited information and the device not being returned.A possible root cause could be attributed to a retraction issue.The complaint states that after placement of the decompression tube, the user attempted to withdraw the inner black tube (guiding catheter) and wire guide whereupon it kinked and broke into two pieces.It is possible that a kink that occurred on the wire guide or catheter during advancement or withdrawal, potentially due to a difficult or tortuous anatomy, leading to additional force required to retract them causing them to subsequently break.Additional information in the form of a standard list of questions were requested but it was stated this was not forthcoming from the customer.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Corrective action/correction: complaints of this nature will continue to be monitored for similar events.Summary of investigation: according to the customer, the device was kinked.Confirmed quantity of 1 device, confirmed used.According to the initial report, the patient did not experience any adverse effects due to this occurrence.Investigation findings conclude that a definitive root cause could not be determined due to limited information and the device not being returned.A possible root cause could be attributed to a retraction issue.The complaint states that after placement of the decompression tube, the user attempted to withdraw the inner black tube (guiding catheter) and wire guide whereupon it kinked and broke into two pieces.It is possible that a kink that occurred on the wire guide or catheter during advancement or withdrawal, potentially due to a difficult or tortuous anatomy, leading to additional force required to retract them causing them to subsequently break.Additional information in the form of a standard list of questions were requested but it was stated this was not forthcoming from the customer.
Event or Problem Description
A supplemental report is being submitted due to the completion of the investigation on 15-aug-2025.

• Brand Name: COLON DECOMPRESSION SET
• Common Device Name: FEG TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; national technology park; limerick 00000 ; IE 00000
• Manufacturer (Section G): COOK IRELAND LTD; o'halloran rd; national technology park; limerick 00000 ; IE 00000
• Manufacturer Contact: sinead o'leary ; o'halloran rd; national technology park; limerick 00000 ; IE 00000 ; 061334440
• MDR Report Key: 22344441
• Report Number: 3001845648-2025-00302
• Device Sequence Number: 14677864
• Product Code: FEG
• UDI-Device Identifier: 00827002221819
• UDI-Public: (01)00827002221819(17)270216(10)C2142988
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K171619
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G22181
• Device Catalogue Number: CDSG-14-175
• Device Lot Number: C2142988
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/16/2025
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 06/27/2025
• Supplement Report FDA Received Date: 09/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown