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

Catalog Number	ACP606
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/03/2025
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information the catheter was found damaged before use (tip bent and twisted) in packaging.Another catheter was used.
Additional Manufacturer Narrative
The investigation is not yet complete, a follow up report will be submitted on completion of the investigation.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaint and we didn't find other complaint regarding the lot number.In october 2025, we received one used sample.After desinfection, sample was visually observed.One extremity of the catheter was crushed.This kind of defect can be done at packaging step.This medical device was pinch between the moulds of packaging equipment.However this product was packaged in two steps, and we cannot determined at what step did the defect occured.According to the informations known quality database was checked and revealed no anomaly in relation to the describe defect.A similar case study was performed based on ureteric catheter defect, damaged/broken over last four years: 11 similar cases were found.A rmf evaluation was performed based on criq208 - risk identified 11200b (hazardous situation: catheter cannot be used) 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.
Event or Problem Description
According to the available information the catheter was found damaged before use (tip bent and twisted) in packaging.Another catheter was used.

• 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: 23236160
• Report Number: 9610711-2025-00437
• Device Sequence Number: 13270371
• Product Code: EYB
• UDI-Device Identifier: 03600040967010
• UDI-Public: 3600040967010
• 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): 03/04/2026

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: ACP606
• Device Lot Number: 10187966_ACP6064002
• 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: 10/07/2025
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2025
• 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
• Patient Sex: Unknown