MAUDE Adverse Event Report: COLOPLAST A/S HYDRO X-FLOW CATHETER SILICONE WITH HYDROGEL COATING; INDWELLING URETHRAL DRAINAGE BALLOON CATHETER, NON-ANTIMICROBIAL

Catalog Number XB6318

Device Problem Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

According to the available information upon insertion of the catheter, the balloon burst on inflation at 30ml.No clinical consequence for the patient.

Event Description

According to the available information upon insertion of the catheter, the balloon burst on inflation at 30ml.No clinical consequence for the patient.

Manufacturer Narrative

According to the complaint description, the lot number is available but not the sample.After receiving this complaint, we searched for other complaints and found none on the lot number 9240226.Checking the quality databases revealed one non-conformity (nc) potentially in relation to the described defect and a corrective and preventive action (capa): - 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.- monitoring capa-000152: "balloon issues on folysil and silicone prostatic catheters".The trending for balloon bursting is specifically monitored.A similar case study was performed based on item number xb63, defect balloon deflation.Balloon burst; defective balloon over last four year, 42 similar cases were found.

• Brand Name: HYDRO X-FLOW CATHETER SILICONE WITH HYDROGEL COATING
• 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: 18222007
• MDR Text Key: 329168979
• Report Number: 9610711-2023-00255
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040260753
• UDI-Public: 3600040260753
• Combination Product (y/n): N
• 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
• Report Date: 11/28/2023

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 Number: XB6318
• Device Lot Number: 9240226_XB63181002
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/28/2023
• Date Device Manufactured: 06/29/2023
• 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