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

Model Number ACB1C31002

Device Problem Fracture (1260)

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

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 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.

Event Description

According to available information, this device was not able to be used due to a break.The device was taken out of the package and it was already broken.The packaging was noted to be in perfect condition.No other adverse patient effects were reported.

Manufacturer Narrative

We have been informed about a defect product, broken stent, on a vortek product.According to the complaint description lot number and one picture are available, but no sample.After receiving this complaint, we searched for other complaints and found none regarding the lot number.Checking the quality databases did not reveal any anomaly in relation to the described defect.We showed the picture to the operators who manufacture this product.According to them, this part is defective.The hypothesis put forward was a machine fault, and that this piece had not been correctly oriented after manufacturing, and should have been destroyed.Following this exchange, we resensitized them to good practices.However, the person responsible for this manufacturing operation no longer works for the company.This issue was due to an human error.

• Brand Name: VORTEK DOUBLE 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: 16894430
• MDR Text Key: 314812244
• Report Number: 9610711-2023-00078
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2023
• Device Model Number: ACB1C31002
• Device Catalogue Number: ACB1C3
• Device Lot Number: 8423656
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2023
• Date Device Manufactured: 01/31/2022
• 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