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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S VORTEK DOUBLE LOOP URETERAL STENT KIT; UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE

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COLOPLAST A/S VORTEK DOUBLE LOOP URETERAL STENT KIT; UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE Back to Search Results
Catalog Number ACBC55
Device Problem Calcified (1077)
Patient Problem Insufficient Information (4580)
Event Date 11/27/2023
Event Type  malfunction  
Event Description
According to the available information during observation uretroscopy surgery evidence of severe indication and calcification on double j catheters.
 
Manufacturer Narrative
We have been informed about a defect product, "calcification on stent", on a vortek double loop ureteral stent.After receiving this complaint, we searched for other complaints and we didn't find any other complaint regarding the lot number 8340286.On 10th january, we received one used sample.At visual examination, we see that the stent is calcified.Checking the quality database revealed no anomaly in relation with the described product.According to the instructions for use, the following events have been reported although their occurrence greatly depends on patients¿ medical conditions: infection, encrustation, obstruction, rupture, migration, bladder irritation symptoms, pain, hematuria, erosion.Regular monitoring for these adverse events should nevertheless be implemented following placement.Periodic monitoring by ultrasonography, radiography and/or cystoscopy is recommended to evaluate stent efficiency and identify any complications.The stent should be removed if drainage is obstructed by encrustation, if there are any signs of infection in the area around the stent or in the event of migration or rupture.Based on the above, this complaint is not confirmed as a product defect but is considered as possible event with the use of this kind of device.
 
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Brand Name
VORTEK DOUBLE LOOP URETERAL STENT KIT
Type of Device
UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE
Manufacturer (Section D)
COLOPLAST A/S
1 holtedam humlebaek, dk 3050
humlebaek 3050
DA  3050
Manufacturer (Section G)
CMF-SARLAT
9 avenue edmond rostand
sarlat-la-caneda
FR  
Manufacturer Contact
usbes brian schmidt
1601 west river road n
minneapolis, MN 55411
MDR Report Key18513863
MDR Text Key332924406
Report Number9610711-2024-00017
Device Sequence Number1
Product Code FAD
Combination Product (y/n)N
Reporter Country CodeIR
PMA/PMN Number
K180057
Number of Events Reported1
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 05/28/2024
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 Catalogue NumberACBC55
Device Lot Number8340286_ACBC551002
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/15/2024
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received05/28/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured11/30/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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