MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. HERO.VENOUS OUTFLOW COMPONENT.; HERO GRAFT

Model Number 00884450310151

Device Problems Material Separation (1562); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during a long-term hemodialysis de-clotting procedure, the distal outflow components radiopaque ring detached while deploying a 7mm x 40mm balloon within a clot located within the hemodialysis outflow component.The account states that all balloon inflations were close to the outflow component radiopaque marker band.Post balloon inflations, the marker band detached from the component but remained on the guidewire.A vascular snare device was quickly advanced to successfully capture the foreign body for safe removal from the patient.No patient injury to report.

Manufacturer Narrative

The suspect device has been returned for evaluation.The product was examined visually.The complaint is confirmed.The root cause was attributed to inflation of the balloon too close to the marker band.A review of the device history and complaint database could not be performed since the lot number was not provided.

• Brand Name: HERO.VENOUS OUTFLOW COMPONENT.
• Type of Device: HERO GRAFT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 10785308
• MDR Text Key: 214565951
• Report Number: 1721504-2020-00090
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00884450310151
• UDI-Public: 00884450310151
• Combination Product (y/n): N
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 00884450310151
• Device Catalogue Number: HERO1001/B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2020
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BOSTON SCI - MAVERICK PTCA BALLOON; BOSTON SCI - MAVERICK PTCA BALLOON
• Patient Outcome(s): Required Intervention