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

Catalog Number	AB6322
Medical Device Problem Codes	Tear, Rip or Hole in Device Packaging (2385); Unintended Deflation (4061)
Health Effect - Clinical Code	Septic Shock (2068)
Date of Event	12/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we found none regarding the lot number 9102930.In this case according to the information received, the balloon was not inflated with the correct volume, 10ml instead of 30-50ml, this misuse could lead to balloon deflation.According to the information known, the quality database was checked and revealed the field safety notice associated with the corrective and preventive action z-0845-2025.All the affected products were recalled on the 5 previous years.The investigation resulted in some corrective actions like the change of the packaging foil, new control tools, and retraining of operators.A similar case study was performed based on scope of recall scope.Defect: packaging issue or infection from (b)(6) 2021 to (b)(6) 2025: 18 similar cases were found.A medical assessment was also performed which concluded: the risk of infection cannot be eliminated, essentially through a contamination cascade from the outer pouch breach to the external surface of the inner pouch, then to the surgeon¿s glove, then to the patient.Taking into account the multiple risk ratios for each step of the cascade, and based on the sensitivity analysis performed, the final risk is not expected to exceed the usual highest rates reported in literature for each device family.
Event or Problem Description
A new 22 fr 3-way catheter with a 10ml balloon was inserted.A balloon patency test was performed before insertion.Later that same night, the catheter was found outside the ureter, with the balloon deflated.The patient stated that he had not touched it.This was the second balloon deflation in two nights.After two balloon deflations, the surgeon suspected silicone porosity.During the night of (b)(6): patient with a fever of 38°c at 9:45 pm.The medical team administered medication to stop the infection and lower the temperature.Checks at 10:50 pm: 38.4°c; 2:00 am: 37.9°c; 5:00 am: 37.5°c.At 5:00 am, the patient complained of feeling cold and was given a duvet and fleece blanket, and the room heating was increased.On (b)(6) at 8:30 am, the patient was shivering, with a temperature of 41.1°c and oxygen desaturation at 86%.The patient was less alert.The patient was transferred to the intensive care unit for septic discharge.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and we found none regarding the lot number.In this case according to the informations received, the balloon was not inflated with the correct volume, 10ml instead of 30-50ml, this misuse could lead to balloon deflation.According to the information known, quality database was checked and revealed a field safety notifice associated with a corrective and preventive action opened on (b)(6) 2024.All the products packaged on the multivac 2 machine were recalled on the 5 previous years.The investigation conducts to some corrective actions like the change of the packaging foil, new control tools, and retraining of operators.The lot impacted in this complaint is part of this fsca.A similar case study was performed based on scope of recall scope, defect: packaging issue or infection from (b)(6) 2021 to (b)(6) 2025: 18 similar cases were found.A rmf evaluation was performed based on criq 250 - risk identified 10111 (hazardous situation: lack of sterile barrier properties for primary packaging) we can conclude that the overall residual risk associated with the use of the medical device when weighed against the benefit/risk ratio to the patient / user is not adequately or insufficiently controlled.Necessary actions need to be taken to review the risk mitigations and to reset the risk criteria in the green area.The harms, severity and occurrence are not within anticipated levels per the risk documentation.A medical assessment was also performed which conclude: the risk of infection appears as moderate but cannot be eliminated, essentially through a contamination cascade from the outer pouch breach to the external surface of the inner pouch, then to the surgeon¿s glove, then to the patient, which is likely to develop an infection process if his own immune system or the antibioprophylaxis are not sufficient.Taking into account the multiple risk ratios for each step of the cascade, and based on the sensitivity analysis performed, the final risk is not expected to exceed the usual highest rates reported in literature for each device family.
Event or Problem Description
A new 22 fr 3-way catheter with a 10ml balloon was inserted.A balloon patency test was performed before insertion.Later that same night, the catheter was found outside the ureter, with the balloon deflated.The patient stated that he had not touched it.This was the second balloon deflation in two nights.After two balloon deflations, the surgeon suspected silicone porosity.During the night of (b)(6): patient with a fever of 38°c at 9:45 pm.The medical team administered medication to stop the infection and lower the temperature.Checks at 10:50 pm: 38.4°c; 2:00 am: 37.9°c; 5:00 am: 37.5°c.At 5:00 am, the patient complained of feeling cold and was given a duvet and fleece blanket, and the room heating was increased.On december 6th at 8:30 am, the patient was shivering, with a temperature of 41.1°c and oxygen desaturation at 86%.The patient was less alert.The patient was transferred to the intensive care unit for septic discharge.

• 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 canéda cedex 24200 ; FR 24200
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 23596209
• Report Number: 9610711-2025-00477
• Device Sequence Number: 13357241
• Product Code: EZL
• UDI-Device Identifier: 03600040144442
• UDI-Public: 3600040144442
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: AB6322
• Device Lot Number: 9102930_AB63221002
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/03/2023
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0845-2025
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Hospitalization
• Patient Sex: Unknown