MAUDE Adverse Event Report: COLOPLAST A/S IMAJIN SILICONE HYDROGEL DOUBLE LOOP URETERAL STENT KIT; UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE

Catalog Number BCHF64

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Event Description

According to the available information the stent was placed in a cancer patient.It tore apart.However, the doctor was able to retrieve all broken pieces and did not leave any behind in the ureter.

• Brand Name: IMAJIN SILICONE HYDROGEL DOUBLE LOOP URETERAL STENT KIT
• Type of Device: UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE
• 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: 18518339
• MDR Text Key: 332931355
• Report Number: 9610711-2024-00018
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 05708932704380
• UDI-Public: 5708932704380
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180469
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BCHF64
• Is the Reporter a Health Professional?: Yes
• 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