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

Catalog Number	ACP405
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
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.B3: unknown date.
Event or Problem Description
According to the available information, the guide wire in the ureteral stent was incorrectly shaped.Typically, the end is shaped into a loop.In this case, the end is pointed and sharp-edged and the doctor pricked his right thumb when pulling out the catheter.The doctor's injury was repaired.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we found none regarding the lot number 10084234.On the picture received, we can see that the metallic loop of the mandrel was broken.According to the information received no other case was known.As a reminder in our ifu sh4033 in warnings and precautions paragraph: "please check the integrity of the device before using this device" and "do not use if the device is damaged".On may 2025, we received the packaging site investigation which conclude: "we could not find any non-conformity regarding this item from the past regarding damage issue.We sorted out lot 9877050 which was available on stock and we also could not find any non-conformity.We tried to recreate the failure on the machine and also by handling the material and we could not do it with normal process.It is also stated in our production procedure, that damaged raw material is not accepted and the operators are handling and inspecting the products according to that.Based on our investigation, the issue did not occured at our site." no root cause could be found about this issue.According to the information known quality database was checked and revealed no anomaly in relation to the describe defect.A similar case study was performed based on ureteric product with defect metallic mandrel broken, between april 2021 and april 2025, no similar case was found a rmf evaluation was also performed based on (b)(4) - 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.It is concluded that the risks identified are still acceptable and considered as safe.
Event or Problem Description
According to the available information, the guide wire in the ureteral stent was incorrectly shaped.Typically, the end is shaped into a loop.In this case, the end is pointed and sharp-edged and the doctor pricked his right thumb when pulling out the catheter.The doctor's injury was repaired.

• 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 Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 21805066
• Report Number: 9610711-2025-00069
• Device Sequence Number: 20725086
• Product Code: EYB
• UDI-Device Identifier: 03600040966624
• UDI-Public: 3600040966624
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: ACP405
• Device Lot Number: 10084234_ACP4054002
• Was Device Available for Evaluation?: No
• 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: 04/09/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/29/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown