MAUDE Adverse Event Report: COLOPLAST A/S X-FLOW CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number	AB63181002
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
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.
Event or Problem Description
According to available information, this device had a burst.The balloon burst after being inflated with less than 50 ml of sterile water.No other adverse patient effects were reported.
Additional Manufacturer Narrative
We have been informed about a defect product, balloon burst on a prostatic product.According to the complaint description lot number is available but no sample.After receiving this complaint, we searched for other complaints and found three similar complaints on the lot number 8899133.Checking the quality databases revealed one non-conformity in relation to the described defect and a corrective and preventive action are ongoing.A documentary investigation revealed no anomaly recorded during production; products were 100% tested at the end of the production.The issue of defect silicone balloon could come from various causes.In this case, we cannot identify any specific root cause because the information provided is insufficient to do so.

• Brand Name: X-FLOW CATHETER
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; sarlat-la-caneda 24206 ; FR 24206
• Manufacturer Contact: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 16943764
• Report Number: 9610711-2023-00092
• Device Sequence Number: 2098876
• Product Code: EZL
• UDI-Device Identifier: 03600040144183
• UDI-Public: 03600040144183
• Combination Product (Y/N): N
• PMA/510(K) Number: K013172
• 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): 08/22/2023

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
• Operator of Device: Health Professional
• Device Model Number: AB63181002
• Device Catalogue Number: AB6318
• Device Lot Number: 8899133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/18/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 05/17/2023
• Supplement Report FDA Received Date: 08/22/2023
• Date Device Manufactured: 11/29/2022
• 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