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

Model Number	00884450310151
Medical Device Problem Codes	Material Separation (1562); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem 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.
Additional 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.
• Common Device Name: HERO GRAFT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 10785308
• Report Number: 1721504-2020-00090
• Device Sequence Number: 14209585
• Product Code: DSY
• UDI-Device Identifier: 00884450310151
• UDI-Public: 00884450310151
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K124039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Initial Date Received by Manufacturer: 10/26/2020
• Supplement Date Received by Manufacturer: 01/05/2021
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 01/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BOSTON SCI - MAVERICK PTCA BALLOON; BOSTON SCI - MAVERICK PTCA BALLOON
• Outcome Attributed to Adverse Event: Required Intervention