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

Model Number ACA1061002

Device Problem Physical Resistance/Sticking (4012)

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

Event Type  malfunction  

Event Description

According to available information, this device required removal due to sticking.When the device was inserted into the guidewire, it was difficult to move forward.The guidewire was not able to be removed from the stent.The stent and the guidewire were both removed.No other adverse patient effects were reported.

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.

Manufacturer Narrative

After receiving this complaint, we could not search for other complaint as the lot number is not available.Unfortunately we have not been given sufficient information to perform a documentary investigation.Checking the quality database revealed no anomaly in relation with the described defect.On 9 june we received one used sample.Sample received was not complete, we received only one part of this medical device.Medical device was not complete, an a little part of this was shredded.Specification length ws 970 +- 2 mm and we received a device with length 391 mm.Guidewire was blocked at 35.3cm after several attempt a gluing matter was found and extract from stent.However we cannot identify this matter ( too little quantity), and the gluing property not corresponding to a product used for this production.

• 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: 17086041
• MDR Text Key: 316805765
• Report Number: 9610711-2023-00111
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2023

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 Model Number: ACA1061002
• Device Catalogue Number: ACA106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/11/2023
• Initial Date FDA Received: 06/08/2023
• Supplement Dates Manufacturer Received: 08/30/2023
• Supplement Dates FDA Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: 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