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

Catalog Number AB6022

Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)

Patient Problems Unspecified Infection (1930); Foreign Body In Patient (2687)

Event Date 09/28/2023

Event Type  Injury  

Event Description

According to the available information, the prostatic catheter was placed on (b)(6) in the indication of continuous bladder irrigation / lavage for macrohematuria, with a bladder irrigation every 24 hours.After 14 days, the catheter burst during the night of (b)(6).The patient was found in the presence of blood, was conscious and able to identify bladder pain.The patient¿s hematuria was reported to have been related to cancer.Upon removal of the catheter, pieces of the balloon were missing.A cystoscopy was not performed and the catheter was not replaced due to the patient's medical condition.The patient was noted be elderly with multiple underlying conditions such as metastatic prostatic cancer, diabetes, and high blood pressure.The patient passed away on (b)(6) due to infection, which was associated with bacteriemia and was of unknown origin.Cytobacteriological examination of urine was not performed.It was reported the catheter had performed irrigation correctly, irrigating nacl 0.9% at 1 liter per 24 hours.The balloon did not burst during irrigation.It was also reported the catheter drained correctly.The patient did not have a history of surgery.It was noted the balloon had been tested (inflated/deflated) before use and had been filled with 50ml eppi.

Manufacturer Narrative

After receiving this complaint, we searched for other complaints and found none on the lot 8763695.Checking the quality databases revealed one non-conformity in relation to the described defect and a corrective and preventive action: (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.Monitoring capa-000152: "balloon issues on folysil and silicone prostatic catheters".The trending for balloon bursting is specifically monitored.A documentary investigation of the balloon component lot number and the intermediate component lot number were carried out, and no quality defect was registered during manufacturing.A similar case study based on item number and defect [misuse], over last four years was performed: no similar case was found.A risk management framework evaluation was performed and concluded that residual risks are adequately controlled and reduced as far as possible, and the residual risks associated with the use of the product are acceptable when weighed against the benefits to the patient/user.It is concluded that the risks identified are still acceptable and considered as safe.A clinical assessment was performed and concluded: "prostatic catheters must only be used by trained and experienced professionals as mentioned in the instructions for use.Balloon burst is a known issue that may be due to a weakness zone in the silicone material of the balloon, a phenomenon reinforced in this case by an inappropriate duration of use for blood bladder irrigation/lavage (14 days vs 7 days maximum).However, even with a duration of use of 14 days, a balloon burst is not expected to cause an infection after a short period of time and even less a patient¿s death.This is in line with post market surveillance data on coloplast prostatic catheters and on comparable devices: no death related to balloon burst was ever reported with a prostatic catheter.Whatever the origin of infection, and considering the chronology of events, coloplast considers that the death of patient is not related to the balloon burst, but to the patient¿s initial condition (metastatic prostate cancer in a non-insulin dependent-diabetes patient, with high blood pressure).In the present case the balloon burst was associated with hematuria, however, we consider that it was more likely related to the previous macroscopic hematuria than a lesion caused by balloon burst.Correction: f12 was removed.

• 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 Key: 18049274
• MDR Text Key: 327090596
• Report Number: 9610711-2023-00238
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• 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: 05/29/2024

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 Catalogue Number: AB6022
• Device Lot Number: 8763695_AB60221002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/01/2023
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/02/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other