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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COLOPLAST A/S X-FLOW PROSTATECTOMY CATHETER; INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL

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COLOPLAST A/S X-FLOW PROSTATECTOMY CATHETER; INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL Back to Search Results
Catalog Number AB6H22
Device Problem Burst Container or Vessel (1074)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
According to the available information the balloon burst inside the patient.
 
Manufacturer Narrative
We received the incriminated sample which allowed us to retrieve the lot number.After decontamination, we see that the balloon was burst without missing part.We searched for other complaints and we didn't find any other complaints regarding the lot number 9177710.This product was made by our subcontractor which was informed about this issue.On january, we received documentary's investigation from our subcontractor, the probably root cause about this issue was raw material's balloon.Checking the quality databases revealed one non-conformity in relation to the described defect and a corrective and preventive action are ongoing: - nc (b)(4): "pb ballons (bulles + agglutinés)" opened in 16 january 2023.For this nc, the used of clumped balloons should be responsible of some weakness on the balloon and being responsible of bursting.- capa-000152: "balloon bursting trending for folysil and silicone prostatic catheters".The trending for balloon bursting is specifically monitored.A similar case study was done based on same item number (b)(4), same defect "balloon burst", over last four year, 6 similar case were found.
 
Event Description
According to the available information the balloon burst inside the patient.
 
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Brand Name
X-FLOW PROSTATECTOMY CATHETER
Type of Device
INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL
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 Key18695951
MDR Text Key335305022
Report Number9610711-2024-00034
Device Sequence Number1
Product Code EZL
UDI-Device Identifier03600040147009
UDI-Public3600040147009
Combination Product (y/n)N
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 Followup
Report Date 06/04/2024
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 NumberAB6H22
Device Lot Number9177710_AB6H221002
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/13/2024
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received06/04/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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