MAUDE Adverse Event Report: COLOPLAST A/S VORTEK DOUBLE LOOP URETERAL STENT; STENT, URETERAL

Model Number ACB1C51002

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

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

Event Date 06/03/2022

Event Type  malfunction  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional information prompt us to alter or supplement any information or conclusions contained in this report, a follow-up report will be submitted.

Event Description

According to the available information, the end of the device detached.The procedure was prolonged, and another product was used.

• Brand Name: VORTEK DOUBLE LOOP URETERAL STENT
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; sarlat-la-caneda 24206 ; FR 24206
• Manufacturer Contact: usaby angela kilian ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 15193417
• MDR Text Key: 302929556
• Report Number: 9610711-2022-00057
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K180057
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2023
• Device Model Number: ACB1C51002
• Device Catalogue Number: ACB1C5
• Device Lot Number: 8355189
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/15/2021
• 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