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

Model Number	789789789
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
According to available information, this device had a balloon burst.The balloon was inflated with 40 ml of eppi.A few minutes later, the nurse noticed that the device was not holding as the balloon had ruptured.A second device of the same diameter was inserted with slightly less eppi (30-35 ml) but the balloon ruptured again.A third device of the same diameter with the same volume of eppi (30-35 ml) but from a different batch to the second was placed.The balloon burst again.Finally, a fourth device (30-35 ml of eppi in the balloon) was placed.As the patient left with this device and it was assumed that the balloon had held.No other adverse patient effects were reported.
Additional Manufacturer Narrative
Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.
Additional Manufacturer Narrative
After receiving this complaint, we searched for other complaints and found none on the lot number 8763695.Checking the quality databases revealed one non-conformity (nc) in relation to the described defect and a corrective and preventive action (capa).During manufacturing step no quality defect was registered during manufacturing on the intermediate component ab632080 lot number 8693909.Products were conformed.The evaluation has showed that risks are adequately controlled and reduced as far as possible in the state of art.Based on this, we can conclude 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.
Event or Problem Description
According to available information, this device had a balloon burst.The balloon was inflated with 40 ml of eppi.A few minutes later, the nurse noticed that the device was not holding as the balloon had ruptured.A second device of the same diameter was inserted with slightly less eppi (30-35 ml) but the balloon ruptured again.A third device of the same diameter with the same volume of eppi (30-35 ml) but from a different batch to the second was placed.The balloon burst again.Finally, a fourth device (30-35 ml of eppi in the balloon) was placed.As the patient left with this device and it was assumed that the balloon had held.No other adverse patient effects were reported.

• 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-caneda ; FR
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 17849128
• Report Number: 9610711-2023-00203
• Device Sequence Number: 14549584
• Product Code: EZL
• UDI-Device Identifier: 03600040144312
• UDI-Public: 3600040144312
• Combination Product (Y/N): N
• 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): 01/12/2024

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
• Device Model Number: 789789789
• Device Catalogue Number: AB6320
• Device Lot Number: 9019353_AB63201002
• 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: 09/30/2023
• Supplement Report FDA Received Date: 01/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown