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U.S. Department of Health and Human Services

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

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COLOPLAST A/S VORTEK DOUBLE LOOP URETERAL STENT Back to Search Results
Model Number ACBC641002
Device Problem Obstruction of Flow (2423)
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 the tube not being perforated.The device was not able to be fitted.No other adverse patient effects were reported.
 
Manufacturer Narrative
We have been informed about a defect product, difficult to fit the catheter, on a vortek catheter.According to the complaint description lot number and sample are available.No other complaints were found regarding the lot number 8290362.Checking the quality databases did not reveal any anomaly in relation to the described defect.According to the complaint's description the issue described is "unperforated tube causing inability to mount the catheter".However we cannot consider this a defect, as this reference is a stent with one open side and one closed side.It therefore complies with the product description.What's more, the sample received complies with the specifications expected for this reference.
 
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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 Key17015384
MDR Text Key316238523
Report Number9610711-2023-00101
Device Sequence Number1
Product Code FAD
Combination Product (y/n)N
PMA/PMN Number
K180057
Number of Events Reported1
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 08/22/2023
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 NumberACBC641002
Device Catalogue NumberACBC64
Device Lot Number8290362
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/05/2023
Initial Date FDA Received05/27/2023
Supplement Dates Manufacturer Received08/21/2023
Supplement Dates FDA Received08/22/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/05/2021
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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