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

Catalog Number ACBC55

Device Problem Calcified (1077)

Patient Problem Insufficient Information (4580)

Event Date 11/27/2023

Event Type  malfunction  

Event Description

According to the available information during observation uretroscopy surgery evidence of severe indication and calcification on double j catheters.

Manufacturer Narrative

We have been informed about a defect product, "calcification on stent", on a vortek double loop ureteral stent.After receiving this complaint, we searched for other complaints and we didn't find any other complaint regarding the lot number 8340286.On 10th january, we received one used sample.At visual examination, we see that the stent is calcified.Checking the quality database revealed no anomaly in relation with the described product.According to the instructions for use, the following events have been reported although their occurrence greatly depends on patients¿ medical conditions: infection, encrustation, obstruction, rupture, migration, bladder irritation symptoms, pain, hematuria, erosion.Regular monitoring for these adverse events should nevertheless be implemented following placement.Periodic monitoring by ultrasonography, radiography and/or cystoscopy is recommended to evaluate stent efficiency and identify any complications.The stent should be removed if drainage is obstructed by encrustation, if there are any signs of infection in the area around the stent or in the event of migration or rupture.Based on the above, this complaint is not confirmed as a product defect but is considered as possible event with the use of this kind of device.

• Brand Name: VORTEK 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: 18513863
• MDR Text Key: 332924406
• Report Number: 9610711-2024-00017
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: IR
• PMA/PMN Number: K180057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/28/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: ACBC55
• Device Lot Number: 8340286_ACBC551002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/28/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/30/2021
• 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