MAUDE Adverse Event Report: LUMENDI, LLC DILUMEN ENDOLUMENAL INTERVENTIONAL PLATFORM

Model Number	DILUMEN 130 CM
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient had a tortuous colon that was difficult to navigate.During navigation the doctor pushed the device too despite feeling resistance.One push rod separated from the fore balloon skirt.No adverse event.

• Brand Name: DILUMEN ENDOLUMENAL INTERVENTIONAL PLATFORM
• Common Device Name: DILUMEN
• Manufacturer (Section D): LUMENDI, LLC; 253 post road west; westport CT 06880
• Manufacturer (Section G): LUMENDI, LLC; 253 post road west; westport CT 06880
• Manufacturer Contact: dennis daniels ; 253 post road west; westport, CT 06880 ; 2034632669
• MDR Report Key: 14332336
• Report Number: 3013505983-2022-00023
• Device Sequence Number: 4961286
• Product Code: FDF
• UDI-Device Identifier: 00865309000225
• UDI-Public: 00865309000225
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K210851
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2022

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
• Device Expiration Date: 09/23/2023
• Device Model Number: DILUMEN 130 CM
• Device Catalogue Number: D-1001
• Device Lot Number: 75GA4837
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 05/08/2022
• Date Device Manufactured: 05/19/2021
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown