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

Model Number FGS-06-UOT.16FST

Device Problems Deflation Problem (1149); Device Dislodged or Dislocated (2923)

Patient Problems Hemorrhage/Bleeding (1888); Urinary Retention (2119)

Event Date 07/22/2022

Event Type  malfunction  

Event Description

Inserted foley catheter, urine return present.Balloon inflated after urine return present w/ 2 rn verification.During procedure, only 4 ml of urine output.Foley catheter flushed with urine and accuryn machine changed as well.No urine output.At end of case, catheter was halfway out of urethra and balloon was not inflated.Blood was also in the catheter.Foley catheter replaced with urine return and 2 rn verification per policy, balloon inflated after urine return.Immediate urine output of 200-300 mls before transferring patient to cardiac icu.

• Brand Name: ACCURYN SMARTFOLEY UO TEMP TRAY SYSTEM 16FR
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): POTRERO MEDICAL, INC.; 26142 eden landing rd; hayward CA 94545
• MDR Report Key: 15657362
• MDR Text Key: 302274533
• Report Number: 15657362
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: FGS-06-UOT.16FST
• Device Catalogue Number: FGS-06-UOT.16FST
• Device Lot Number: C21120101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/03/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Sex: Male
• Patient Weight: 91 KG