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

Catalog Number	AB6318
Medical Device Problem Codes	Inflation Problem (1310); Failure to Deflate (4060); Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to available information, this device required replacement due to difficult inflation.The device was difficult to inflate and impossible to deflate.The device eventually self-deflated.The balloon was intact after device removal.It is suspected that the problem was with the valve.No other adverse patient effects were reported.
Additional 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.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and found none on the lot 9018842.Checking the quality databases revealed one corrective and preventive action are ongoing documentary investigation was performed about this lot, no issue were registered during production.On august we received one used sample.After disinfection, medical device was tested.The balloon can be inflated with water but the valve is leaking and the green piston inside the valve is askew and seems to be pushed in.On 27th october, we received the investigation from our subcontractor : the cause of the defect is a valve problem (offset piston).
Event or Problem Description
According to available information, this device required replacement due to difficult inflation.The device was difficult to inflate and impossible to deflate.The device eventually self-deflated.The balloon was intact after device removal.It is suspected that the problem was with the valve.No other adverse patient effects were reported.

• Brand Name: X-FLOW PROSTATECTOMY CATHETER
• Common Device Name: 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 Key: 17549895
• Report Number: 9610711-2023-00171
• Device Sequence Number: 15169290
• Product Code: EZL
• UDI-Device Identifier: 03600040144183
• UDI-Public: 3600040144183
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2024

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 Catalogue Number: AB6318
• Device Lot Number: 9112206_AB63181002
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2023
• Supplement Report FDA Received Date: 01/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown