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

Catalog Number ACP605

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

According to the available information during placement of the jj catheter, peeling/small blue fragments are seen in the ureter, which was suspected from either the ureteral catheter or peeling from the guide.No harm to patient.

• Brand Name: URETERIC INTERVENTIONAL CATHETER
• Type of Device: 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-caneda ; FR
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18727297
• MDR Text Key: 335700159
• Report Number: 9610711-2024-00038
• Device Sequence Number: 1
• Product Code: EYB
• Combination Product (y/n): N
• PMA/PMN Number: K171043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ACP605
• Device Lot Number: 9304369_ACP6051002
• Is the Reporter a Health Professional?: Yes
• Date Device Manufactured: 08/15/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other