MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL CATHETER; CATHETER, RETENTION TYPE, BALLOON

Model Number	AA63161002
Medical Device Problem Code	Burst Container or Vessel (1074)
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 required removal due to a balloon burst.The administrative technician at the medical facility said the device balloon burst after placement.It happened in less than a week of using the device by the user.No other adverse patient effects were reported.
Additional Manufacturer Narrative
According to available information, this device required removal due to a balloon burst.The administrative technician at the medical facility said the device balloon burst after placement.It happened in less than a week of using the device by the user.No other adverse patient effects were reported.According to the complaint description lot number is available but no sample.After receiving this complaint, we searched for other complaints and found none about the lot 765752.Checking the quality databases revealed one non-conformity in relation to the described defect and a corrective and preventive action is ongoing "balloon bursting trending for folysil and silicone prostatic catheters." however, the issue of bursting 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.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.

• Brand Name: FOLYSIL 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: 16585762
• Report Number: 9610711-2023-00041
• Device Sequence Number: 19241177
• Product Code: EZL
• UDI-Device Identifier: 03600040128770
• UDI-Public: 03600040128770
• Combination Product (Y/N): N
• PMA/510(K) Number: K013174
• 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): 06/12/2023

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 Expiration Date: 11/02/2025
• Device Model Number: AA63161002
• Device Catalogue Number: AA6316
• Device Lot Number: 7657522
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 03/21/2023
• Supplement Report FDA Received Date: 06/12/2023
• Date Device Manufactured: 11/05/2020
• 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