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

Model Number ACA1081002

Device Problem Partial Blockage (1065)

Patient Problems Pain (1994); Hematuria (2558)

Event Type  Injury  

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 required additional surgery due to pain.The patient had abdominal pain from the device stiffness.The bag replacement caused hematuria and produced deposits inside the device lumen so the urine did not flow well.No other adverse patient effects were reported.

Manufacturer Narrative

According to the complaint description, the incriminated sample is not available, but we have the lot number.After receiving this complaint, we searched for other complaints and found none regarding the lot number 1001079.The sample of product reference (b)(4), lot number 10010719 was manufactured in february 2010.The expiry date is january 2015.Checking the quality databases did not reveal any anomaly in relation to the described defect.Documentary investigation revealed that product was expiry since january 2015.So, this product should not have been used after this date.Rmf identification was done based on criq215 risk no:10300 product performance does not meet specifications.

• 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: 16539769
• MDR Text Key: 311256394
• Report Number: 9610711-2023-00038
• 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: 04/25/2023

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 Expiration Date: 01/01/2015
• Device Model Number: ACA1081002
• Device Catalogue Number: ACA108
• Device Lot Number: 10010719
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2023
• Initial Date FDA Received: 03/14/2023
• Supplement Dates Manufacturer Received: 04/20/2023
• Supplement Dates FDA Received: 04/25/2023
• Date Device Manufactured: 01/01/1900
• 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