MAUDE Adverse Event Report: COLOPLAST A/S URETERIC CATHETER FOR RETROGRADE URETERO-PYELOGRAPHY; URETERAL CATHETER

Catalog Number	AC5910
Medical Device Problem Code	Degraded (1153)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and did not find any other complaints regarding lot number 9729573.
Event or Problem Description
According to the available information, the catheter tip has a defect with a high risk that the tip could break off in the patient.A new catheter was used.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and did not find any other complaints regarding lot number 9729573.This product was made in our manufacturing and packaged at our hungary's site.After analysing the sample, this type of defect is unlikely to have been caused during the manufacture of the product.We believe that it could have occurred during the packaging stage, but unfortunately the defect could not be reproduced, so no root cause could be determined.The operators have been informed about this failure and we will monitor similar issues according to the informations known, quality database was checked and revealed no anomaly in relation to the describe defect.
Event or Problem Description
According to the available information, the catheter tip has a defect with a high risk that the tip could break off in the patient.A new catheter was used.

• Brand Name: URETERIC CATHETER FOR RETROGRADE URETERO-PYELOGRAPHY
• Common Device Name: URETERAL CATHETER
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 20725750
• Report Number: 9610711-2024-00317
• Device Sequence Number: 20909179
• Product Code: EYB
• UDI-Device Identifier: 03600040964255
• UDI-Public: 3600040964255
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K182122
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2025

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 Catalogue Number: AC5910
• Device Lot Number: 9729573_AC59104002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2024
• 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): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown