MAUDE Adverse Event Report: POTRERO MEDICAL, INC. ACCURYN SMARTFOLEY 16FR IAP UO TEMP; CATHETER, RETENTION TYPE, BALLOON

Catalog Number FGS-O6-AIP.16FST

Patient Problem Insufficient Information (4580)

Event Date 01/08/2024

Event Type  malfunction  

Event Description

Foley balloon inflation ports have been spontaneously breaking on several patients, most recent one this morning.The manufacturer and kit are accuryn smartfoley 16fr iap uo temp ref#fgs-06-aip.16fst.

• Brand Name: ACCURYN SMARTFOLEY 16FR IAP UO TEMP
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): POTRERO MEDICAL, INC.
• MDR Report Key: 18782039
• MDR Text Key: 336333584
• Report Number: MW5151968
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 02/12/2024

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
• Device Catalogue Number: FGS-O6-AIP.16FST
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/23/2024
• Patient Sequence Number: 1