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 Off-Label Use (1494)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As initially reported to customer relations: a patient of undisclosed gender and age underwent a colon decompression procedure in which the colon decompression set, g22181, was used.Once the device was in the target area it was under fleuro control at the beginning of the procedure.At the time of pulling out the guide wire and guide catheter at the same time is impossible.The wire can be removed but the guide catheter gets stuck in the decompression tube.The kit was disassembled and reassembled after lubricant applied but guide catheter stays stuck.And the guide catheter changed form, it elongated/stretched out.It was also impossible to re-insert the wire at this point as well.The physician stated the procedure was useless and the patient was sent to surgery for a scan and intestinal resection.The patient was hospitalized and per the physician it is unknown for what length of time.Additional information provided per district managers follow up phone discussion.Tl 02feb2024 the scope was a olympus colonoscope cf-hq190l.Also, the surgeon undid the volvulus using the colonoscope but then the colon decompression didn't work following the untwisting of the volvulus with the scope.Patient outcome: the physician stated the procedure was useless and the patient was sent to surgery for a scan and intestinal resection.The patient was hospitalized and per the physician it is unknown for what length of time.Patient/event info - notes: 1.1 for all complaints, ask: 1.1.1 was the device flushed before use? yes 1.1.2 what was flushed through the device (water, saline, etc.)? water and lubricant jelly ¿ if other please specify 1.1.3 was lubrication applied to the decompression tube? yes 1.1.4 details of the wire guide used (diameter, type, make)? not informed 1.1.5 if not with the device in question, how was the procedure finished? the patient was sent to surgery for a scan and intestinal resection.The patient was hospitalized and per the physician it is unknown for what length of time.1.1.6 please advise the anatomical location of the intended target site.Colon 1.1.7 how experienced was the physician with using the cdsg? per dm- not sure how many times but has used the device many times 1.1.8 did the patient require any additional procedures as a result of this event? the patient was sent to surgery for a scan and intestinal resection.The patient was hospitalized and per the physician it is unknown for what length of time.1.1.9 what intervention (if any) was required? the patient was sent to surgery for a scan and intestinal resection.The patient was hospitalized and per the physician it is unknown for what length of time.1.1.10 was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? same day- the patient was sent to surgery for a scan and intestinal resection.The patient was hospitalized and per the physician it is unknown for what length of time.1.1.11 were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? none noted- device is not available to return.¿ if yes, please specify what was observed and where on the device it was observed.1.1.12 what is the endoscope manufacturer and model number that was used? the scope was a olympus colonoscope cf-hq190l.1.1.13 was resistance encountered when advancing the decompression tube into position? not informed 1.1.14 if resistance was encountered, was the endoscope withdrawn a short distance? not informed 1.1.15 how often was the decompression tube irrigated? not informed 1.1.16 did any section of the device detach inside the endoscope or patient? no 1.1.17 how long was the set left in dwelling? this was the initial procedure.

• 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: 18789080
• MDR Text Key: 337521939
• Report Number: 3001845648-2024-00074
• 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
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2024
• Device Catalogue Number: CDSG-14-175
• Device Lot Number: C1815915
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/01/2024
• Event Location: Hospital
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2021
• 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