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

Catalog Number	AB6020
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
According to the available information during testing of the catheter outside the patient, the balloon was very hard to inflate and impossible to deflate.The balloon was inflated with a 50ml syringe and sterile water.A new catheter was used to complete the case.
Event or Problem Description
According to the available information during testing of the catheter outside the patient, the balloon was very hard to inflate and impossible to deflate.The balloon was inflated with a 50ml syringe and sterile water.A new catheter was used to complete the case.
Additional Manufacturer Narrative
On 30th october, we received one used sample.The sample had a yellow valve ch20 lot number 8352035.After made a tracking we found that the product reference is ab63201002 lot number 8559636 manufactured in may 2022 for 1175 pieces.The expiry date is may 2027.After receiving this complaint, we searched for other complaint and we didn't find other complaint regarding lot number 8559636.Checking the quality databases revealed one anomaly in connection with the described defect, a capa monitoring (capa-000152) on balloon issues on folysil and silicone prostatic catheters.The trending for inflation and deflation issues is followed and is below the threshold of 25 ppm.On 30th october, we received the sample with the balloon inflated.After decontamination with anioxyde 1000, we observed the balloon and we tested the deflation of it and we didn't have problems on 29th december, we received investigation from our subcontractor : "a leak test was carried out, and no defects were detected, the inflation and deflation of the balloon was carried out easily and without difficulty".

• 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: 18040461
• Report Number: 9610711-2023-00234
• Device Sequence Number: 15289880
• Product Code: EZL
• UDI-Device Identifier: 03600040143230
• UDI-Public: 3600040143230
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2024

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: AB6020
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 04/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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