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

Model Number	AA61181002
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Pain (1994)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information, during loading of the guidewire, the guide wire didn't slide in the catheter, thus the guide wire looped in the extremity and never got out.The replacement of the catheter assisted by guidewire can't be done and finished without it.Clinical consequences: use of cystocath, so heavy pain and mobilization of medical and paramedical staff, ultrasound, anesthetic gas, etc.It was noted "use of a lot of xylocaine gel," and that the cause of the event was the product.

• Brand Name: FOLYSIL CATHETER
• Common Device Name: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 12668522
• Report Number: 9610711-2021-00100
• Device Sequence Number: 1231265
• Product Code: EZL
• UDI-Device Identifier: 03600040127605
• UDI-Public: 03600040127605
• 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
• Report Date (Section B): 10/20/2021

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 Expiration Date: 03/09/2026
• Device Model Number: AA61181002
• Device Catalogue Number: AA6118
• Device Lot Number: 7919593
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 10/20/2021
• 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