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

Model Number	AA61061002
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 balloon was not checked for inflation or deflation before placement because the user did not intend to inflate it.They only wanted to perform an evacuating catheterization, but they did not have the right sized device available.The flow was very slow so the balloon was inflated about 10 minutes.After various attempts to deflate the balloon (2 ml, 1 ml, 20 ml syringe, ll), he finally added 0.5 ml of sterile water in the balloon (i.E.2 ml instead of 1.5 ml) and the balloon burst.The user was able to remove the device without any problem.No piece of balloon remained in the patient.
Additional Manufacturer Narrative
We have been informed about a defect product: balloon deflation impossible; on a folysil catheter.After receiving this complaint, we searched for other complaints and found none regarding lot 8996565.Checking the quality databases did not reveal any anomaly in relation to the described defect and a corrective and preventive action is ongoing tw (b)(4) "balloon bursting trending for folysil and silicone prostatic catheters." a similar case study was done on item number aa6106 and defect deflation impossible or difficult, 1 similar case was found.On 15th may, we received one used sample.After disinfection with anioxide 1000 sample was tested.Balloon was burst but we can test the valve.We have injected and collected air and water from the valve, no issue was observed.No root cause could be established after sample's investigation.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.

• 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: 16913399
• Report Number: 9610711-2023-00081
• Device Sequence Number: 2189037
• Product Code: EZL
• UDI-Device Identifier: 03600040126844
• UDI-Public: 03600040126844
• 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): 07/20/2023

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: AA61061002
• Device Catalogue Number: AA6106
• Device Lot Number: 8996565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/14/2023
• Supplement Date Received by Manufacturer: 06/27/2023
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2023
• 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 Age: 1 MO
• Patient Sex: Unknown