MAUDE Adverse Event Report: COLOPLAST A/S VORTEK SINGLE LOOP URETERAL STENT

Model Number ACA2081002

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

According to available information, this device required revision due to repeated clogging.The device seems to be clogged by mucous deposits which persist despite flushing.The doctor noted the device clogs faster than usual with obstruction and has more frequent device revisions.The patient had unusual bleeding.The doctor noted that he is new to this device.

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 facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

• Brand Name: VORTEK SINGLE LOOP URETERAL STENT
• Type of Device: URETERAL STENT
• 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: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 16268942
• MDR Text Key: 308438946
• Report Number: 9610711-2023-00002
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K201436
• 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: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACA2081002
• Device Catalogue Number: ACA208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/18/2022
• Initial Date FDA Received: 01/30/2023
• 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): Required Intervention