MAUDE Adverse Event Report: COLOPLAST A/S URETERIC INTERVENTIONAL CATHETER; URETERAL CATHETER

Catalog Number	ACP305
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/02/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is not yet complete, a follow up report will be submitted on completion of the investigation.
Event or Problem Description
According to the available information the catheter was inserted without difficulty and the contrast agents were administered.During removal, the catheter broke in two, resulting in a piece of the catheter remaining in the ureter.Foreign body forceps were used to remove the piece of catheter stuck in the ureter.The piece was successfully removed.
Event or Problem Description
According to the available information the catheter was inserted without difficulty and the contrast agents were administered.During removal, the catheter broke in two, resulting in a piece of the catheter remaining in the ureter.Foreign body forceps were used to remove the piece of catheter stuck in the ureter.The piece was successfully removed.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we found none regarding the lot number.A documentary investigation was performed and revealed no anomaly registered during production.According to the information known quality database was checked and revealed no anomaly in relation to the describe defect.No sample was received, if the sample is received, the complaint will be reopened for analysis.A similar case study was performed based on ureteric product, damaged / broken during use over last four year: 3 three similar cases were found a rmf evaluation was performed based on criq 208 - risk identified 11606 (hazardous situation: catheter cannot be removed entirely) the evaluation has showed that risks are adequately controlled and reduced as far as possible in the state of art level.Based on this, we can conclude that residual risks are adequately controlled and reduced as far as possible, and the residual risks associated with the use of the product are acceptable when weighed against the benefits to the patient/user.The harms, severity and occurrence are within anticipated levels per the risk documentation.It is concluded that the risks identified are still acceptable and considered as safe.

• Brand Name: URETERIC INTERVENTIONAL CATHETER
• Common Device Name: URETERAL CATHETER
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer (Section G): CMF-SARLAT; 9 avenue edmond rostand; sarlat la canéda cedex 24200 ; FR 24200
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 23169345
• Report Number: 9610711-2025-00428
• Device Sequence Number: 8991654
• Product Code: EYB
• UDI-Device Identifier: 03600040966266
• UDI-Public: 3600040966266
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K171043
• 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): 01/06/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ACP305
• Device Lot Number: 10259398_ACP3054002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown