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

Lot Number C23071001

Patient Problem Failure of Implant (1924)

Event Date 02/13/2024

Event Type  malfunction  

Event Description

Patient had potrero accuryn iap uo temp foley placed 6 days ago (ref: fgs-06-uot.16fst, lot# c23071001).Today the balloon inflation port spontaneously broke off necessitating foley replacement.An identical break happened to a different patient with same brand foley about 2 weeks ago.

• Brand Name: POTRERO ACCURYN IAP UO TEMP FOLEY
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): POTRERO MEDICAL, INC.
• MDR Report Key: 18798463
• MDR Text Key: 336546573
• Report Number: MW5152061
• 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: Other
• Type of Report: Initial
• Report Date: 02/14/2024

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 Lot Number: C23071001
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/27/2024
• Patient Sequence Number: 1