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

Catalog Number AJ4U85

Device Problem Nonstandard Device (1420)

Patient Problem Insufficient Information (4580)

Event Date 10/12/2023

Event Type  malfunction  

Event Description

According to the available information, the stent did not open at the kidney end.The end of jj was not permeable, and it was impossible to pass guide through jj.

• Brand Name: IMAJIN DOUBLE LOOP URETERAL STENT KIT IN SILICONE
• 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: 18110597
• MDR Text Key: 328062245
• Report Number: 9610711-2023-00242
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 03600040203453
• UDI-Public: 3600040203453
• Combination Product (y/n): N
• PMA/PMN Number: K213185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AJ4U85
• Device Lot Number: 9320415_AJ4U851002
• Is the Reporter a Health Professional?: Yes
• Date Device Manufactured: 08/07/2023
• 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