MAUDE Adverse Event Report: MERIT MEDICAL EMBOSPHERES MICROSPHERES; AGENTS, EMBOLIC, FOR TREATMENT OF BENIGN PROSTATIC HYPERPLASIA

Model Number S420GH

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Death (1802); Dysphagia/ Odynophagia (1815); Renal Failure (2041); Low Oxygen Saturation (2477); Cognitive Changes (2551)

Event Date 07/10/2019

Event Type  Death  

Event Description

Subject reported to hosp on (b)(6) 2019 with generalized abdominal pain and dysphagia.Pt was transferred from the general medicine floor to the icu on (b)(6) 2019 for worsening encephalopathy as well as worsening renal function, likely due to hepatorenal syndrome.Overnight, the pt required hfnc at 60l at 100% fio2.During the morning of (b)(6) 2019, the pt was noted to be desatting on hfnc.Due to worsening mental status and concern for airway compromise, the pt was emergently intubated.Family was able to come in and decision was made to provide the pt comfort care.The pt was pronounced deceased at 1258 on (b)(6) 2019.Pt enrolled in study with ide device (b)(4).Local irb made aware on 07/11/2019.

• Brand Name: EMBOSPHERES MICROSPHERES
• Type of Device: AGENTS, EMBOLIC, FOR TREATMENT OF BENIGN PROSTATIC HYPERPLASIA
• Manufacturer (Section D): MERIT MEDICAL
• MDR Report Key: 8811373
• MDR Text Key: 151780011
• Report Number: MW5088259
• Device Sequence Number: 1
• Product Code: NOY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: S420GH
• Device Catalogue Number: S420GH/A
• Device Lot Number: X1168511-5
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/19/2019
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 65 YR
• Patient Weight: 104