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

Model Number AA61161002

Device Problem Infusion or Flow Problem (2964)

Patient Problems Pain (1994); Perforation (2001); Burning Sensation (2146); Hematuria (2558)

Event Date 07/01/2021

Event Type  Injury  

Manufacturer Narrative

The product was returned for evaluation.The flow rate was measured three times, and was determined to be ok.

Event Description

According to the available information, the catheter did not drain the bladder properly, resulting in a double perforation during the passage of the awls for placing the suburethral strip.The strip had to be removed on d + 2.The incident resulted in pain, hematuria, and burning during urination.The procedure was extended by 30 minutes.

Event Description

Additional information received further clarified that the perforation was in the bladder.The balloon had been tested prior to use with no issue; there was no visible anomaly.The catheter was correctly in place, and was not difficult to insert.The catheter did not properly drain the bladder from the start.It was noted the surgeon was experienced.The perforation occurred because the bladder was not empty, as the catheter did not empty the bladder.

• Brand Name: FOLYSIL CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 12266832
• MDR Text Key: 264728442
• Report Number: 9610711-2021-00061
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040127490
• UDI-Public: 03600040127490
• Combination Product (y/n): N
• PMA/PMN Number: K013174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 09/21/2021

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
• Device Operator: Health Professional
• Device Model Number: AA61161002
• Device Catalogue Number: AA6116
• Device Lot Number: 7810304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Initial Date Manufacturer Received: 07/06/2021
• Initial Date FDA Received: 08/03/2021
• Supplement Dates Manufacturer Received: 08/12/2021
• Supplement Dates FDA Received: 09/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other