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

Model Number G22181

Device Problems Material Fragmentation (1261); Off-Label Use (1494)

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

Event Date 10/07/2022

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

Per complaint email from the customer: the event described below has occurred with 3 of the 14 fr.Colon decompression sets, i think it is lot c1942082 but am not 100% sure on this.For the incident on (b)(6) 2022, the set was prepped with a hot water and ky jelly solution by removing the guidewire and flushing the mixture through the catheter and then reinserting the guidewire in the catheter.The md placed the catheter and when attempting to remove the guidewire the rubber type coating started cracking and stripping off the guidewire.The catheter appeared to be kinking while we were attempting to remove the guidewire.Because we thought this might be an isolated event, we opened another set and prepped it the same way as described above, and we had the same outcome.The md pulled the catheter about halfway out from where it was, and we were able to remove the guidewire, but it was still with much difficulty.(b)(4).After discussing the event one of our other nurses told me that the same thing had happened to them last week, she stated, that they were able to use a hemostat to pull the guidewire out in their situation, but it was very difficult, and the rubber type coating was breaking and pulling off.(b)(4).Per mdr: guidewire for colon decompression set started stripping the rubber off when attempting to be removed from the catheter.The catheter was kinking.After using a hemostat, the surgeon was able to remove the guidewire and the catheter placement was successful.Manufacturer response for 14fr colon decompression set, cook (per site reporter).They told them to prep with water and ky.What was the original intended procedure? : colon decompression.What problem did the user have (check all that apply) :device malfunction - that is, the device did not do what it was supposed to do; sg2 7oct2022.Did any unintended section of the device remain inside the patient¿s body? no was the patient hospitalized or was there prolonged hospitalization? the patient was already hospitalized prior to the procedure, the hospitalization was not prolonged due to this.Did the patient require any additional procedures due to this occurrence? no did the product cause or contribute to the need for additional procedures? no has the complainant reported any adverse effects on the patient due to this occurrence? no has the complainant reported that the product caused or contributed to the adverse effects? n/a was the device flushed before use? yes what was flushed through the device (water, saline, etc.)? mixture of hot water & ky were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? catheter appeared to be kinking while we were attempting to remove the guidewire.Was lubrication applied to the decompression tube? yes details of the wire guide used (diameter, type, make)? the wire that comes in the 14fr.Decompression set please advise the anatomical location of the intended target site.The colon how experienced was the physician with using the cdsg? 3-5 years of experience if i had to guess.What intervention (if any) was required? none.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a.What is the endoscope manufacturer and model number that was used? olympus pcf-h190dl.Was resistance encountered when advancing the decompression tube into position? no.If resistance was encountered, was the endoscope withdrawn a short distance? n/a.How often was the decompression tube irrigated? once.Did any section of the device detach inside the endoscope or patient? no.How long was the set left in dwelling? inserted (b)(6) 2022, removed (b)(6) 2022.

Manufacturer Narrative

Pma/510(k) # k171619.This follow up cancellation report is being submitted as the device used in the procedure was confirmed to be not used as off-label on 10-nov-2022.

Event Description

This follow up cancellation report is being submitted as the device used in the procedure was confirmed to be not used as off-label on 10-nov-2022."usage of cdsg for flexible sigmoidoscopy is not off-label.".

• 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: 15769822
• MDR Text Key: 308020054
• Report Number: 3001845648-2022-00762
• Device Sequence Number: 1
• Product Code: FEG
• UDI-Device Identifier: 00827002221819
• UDI-Public: (01)00827002221819(17)250516(10)C1942082
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: G22181
• Device Catalogue Number: CDSG-14-175
• Device Lot Number: C1942082
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/07/2022
• Event Location: Hospital
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2022
• 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
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 94 KG