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	Material Split, Cut or Torn (4008); Unintended Deflation (4061)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and found none regarding the lot number 9772595.
Event or Problem Description
According to the available information the patient received a new flushing catheter at the urology outpatient clinic in the morning around 10:30 am.At 12:30 pm the catheter was next to the patient.The patient was sitting on the edge of the bed.The balloon of the catheter was deflated.When examining the catheter, it appears that the injection point for the balloon has been completely torn off, causing water to escape from the balloon and the catheter to fall out.A new flushing catheter was inserted.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and found none regarding the lot number 9772595.On 28th august, we received one used sample.After decontamination, we observed that the inflation track is torn off.This issue may due to an excess of force which was caused by a patient's moove.Based on the supplier's investigation, the root cause may due to a wrong patient movement that may have caused the tear.According to the information known and investigation done quality database was checked and revealed no anomaly in relation to the described defect.A similar case study was performed based on same item number ab63xx, defect: damaged broken over last four years: 6 similar cases were found.
Event or Problem Description
According to the available information the patient received a new flushing catheter at the urology outpatient clinic in the morning around 10:30 am.At 12:30 pm the catheter was next to the patient.The patient was sitting on the edge of the bed.The balloon of the catheter was deflated.When examining the catheter, it appears that the injection point for the balloon has been completely torn off, causing water to escape from the balloon and the catheter to fall out.A new flushing catheter was inserted.

• 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 Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 19923769
• Report Number: 9610711-2024-00199
• Device Sequence Number: 7602415
• Product Code: EZL
• UDI-Device Identifier: 03600040144442
• UDI-Public: 3600040144442
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 12/31/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: AB6322
• Device Lot Number: 9772595_AB63221002
• Is the Reporter a Health Professional?: Yes
• 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: 08/06/2024
• Supplement Report FDA Received Date: 12/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• 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