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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S VORTEK PERCUTANEOUS NEPHROSTOMY KIT WITH J CATHETER; UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE
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COLOPLAST A/S VORTEK PERCUTANEOUS NEPHROSTOMY KIT WITH J CATHETER; UROLOGICAL SURGICAL PROCEDURE KIT, NON-MEDICATED, SINGLE USE Back to Search Results
Catalog Number RJA208
Device Problems Fracture (1260); Compatibility Problem (2960)
Patient Problem Foreign Body In Patient (2687)
Event Type  Injury  
Event Description
According to the available information the metal guide of the implant (supplied in the kit) broke during passage through the drain.The piece that remained in the patient was removed under a brightness enhancer.
 
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Brand Name
VORTEK PERCUTANEOUS NEPHROSTOMY KIT WITH J CATHETER
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 Key18607447
MDR Text Key334105700
Report Number9610711-2024-00025
Device Sequence Number1
Product Code LJE
UDI-Device Identifier03600040257883
UDI-Public3600040257883
Combination Product (y/n)N
PMA/PMN Number
K211911
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 01/30/2024
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 Catalogue NumberRJA208
Device Lot Number9213378_RJA2081002
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/30/2024
Date Device Manufactured05/31/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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