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

Model Number BCFG741002

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Type  malfunction  

Manufacturer Narrative

D4 lot number: 9070782.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 item number was a 7 ch/fr device; however, the stent in the package was 8 ch/fr.The pusher was 7 ch/fr, so the connection did not fit intraoperatively.

Manufacturer Narrative

We have been informed about a defect product: jj in ch.8 in the packaging according to the complaint description, the sample are available and the lot number.After receiving this complaint, we searched for other complaints with the same lot number 9070782.Checking the quality database revealed no anomaly in relation with the describe defect.On july we received sealed sample.After observation we note that jj item number ycv284 ch8 were packaged instead of jj item number ych17490 ch7 were packaged.Production unit for this product was informed about this defect.An awareness was already done about this topic on may.

• Brand Name: VORTEK HYDRO-COATED 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: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 17089972
• MDR Text Key: 317687557
• Report Number: 9610711-2023-00115
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K170362
• 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: BCFG741002
• Device Catalogue Number: BCFG74
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/01/2023
• 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