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

Catalog Number AB6R18

Device Problem Material Rupture (1546)

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

Event Type  malfunction  

Event Description

According to the available information that when the patient was turned over in bed, the urinary catheter fell out and the balloon was observed to be deflated.When the healthcare professional tested the balloon, a fissure was noted in the balloon.A new catheter was inserted.

Event Description

According to the available information that when the patient was turned over in bed, the urinary catheter fell out and the balloon was observed to be deflated.When the healthcare professional tested the balloon, a fissure was noted in the balloon.A new catheter was inserted.

Manufacturer Narrative

In november, we received one used sample.We observed that balloon was burst without missing part.The sample had a red valve ch18 lot number 8854622.After made a tracking we found that the product reference is ab6r181002 lot number 9041111 manufactured in february 2023 for (b)(4).The expiry date is february 2028.After receiving this complaint, we searched for other complaint and we didn't find other complaint regarding the lot number 9041111.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.Capa-000152: "balloon bursting trending for folysil and silicone prostatic catheters".The trending for balloon bursting is specifically monitored.A similar case study was performed based on item number ab6r, defect balloon deflation.Balloon burst; defective balloon over last four year, 15 similar cases were found.To our knowledge / understanding of the event, the prostatic catheter ref.Ab6r18 was placed for unknown indication and the balloon burst (¿fissure¿) when the patient returned to his room requiring re-intervention for change of catheter possibly under general anesthesia, which is severity parameter 3.

• 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: 18118763
• MDR Text Key: 327913394
• Report Number: 9610711-2023-00243
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040278369
• UDI-Public: 3600040278369
• 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: 11/13/2023

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: AB6R18
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/13/2023
• 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