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

Model Number	AA61061002
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2021
Type of Reportable Event	Serious Injury
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 supplemental reports, a follow-up report will be submitted.
Event or Problem Description
According to the available information, the device was damaged.
Event or Problem Description
According to the available information, the catheter tears off after about two hours at the junction with the branch.This is a predetermined breaking point when the catheter twists back and forth due to the child¿s movement.When the catheter breaks off, it unblocks and slips out.The catheter was placed for drainage and urethral leaking, and tutoring following urethroplasty surgery.The catheter was placed for bladder drainage and splinting of the urethroplasty.The patient¿s pathology was hypospadias.A suprapubic catheter had to be placed under anesthesia.The result of the urethroplasty surgery is not certain because the catheter is missing as a placeholder in the urethroplasty.It was noted this device issue occurred in about five cases, but the outcome was not severe in the other cases.The patients were about 5 or 6 years old, or a little older.When they wake up from anesthesia, they are very active, kicking and moving around a lot.It was noted no adhesive was used to secure the catheter/there was no stuck adhesive on the catheter.The physician attempted to recreate the defect but was not successful.The force he had to use to tear the sample catheter at the site of the rupture was quite high.In the actual incident, the catheter had ruptured with little effort.
Additional Manufacturer Narrative
Sealed products were returned; the products that had been used were not received for analysis.

• Brand Name: FOLYSIL CATHETER
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; sarlat-la-caneda 24206 ; FR 24206
• MDR Report Key: 12362435
• Report Number: 9610711-2021-00062
• Device Sequence Number: 3812492
• 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: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AA61061002
• Device Catalogue Number: AA6106
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/29/2021
• Supplement Date Received by Manufacturer: 07/29/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 10/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention