MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. SUPERHERO HEMODIALYSIS RELIABLE OUTFLOW; VASCULAR GRAFT PROSTHESIS

Catalog Number SUPERHERO

Device Problem Migration (4003)

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

Event Date 11/17/2023

Event Type  malfunction  

Event Description

The account alleges that approximately 2-3 weeks post venous outflow component [voc] implant procedure, the voc implant had migrated out of the patient's right atrium and had rotated laterally inside the patient's arm just past the patient's shoulder.The physician elected to extract the voc along with the graft from the patient's arm.The patient is currently receiving dialysis via a central venous catheter.No patient injury to report.

Manufacturer Narrative

The suspect device is not expected to return for evaluation.The complaint could not be confirmed.The root cause could not be determined.A review of the device history and complaint database could not be performed since the lot number was not provided.Should the device be returned later, the investigation will be reopened.

• Brand Name: SUPERHERO HEMODIALYSIS RELIABLE OUTFLOW
• Type of Device: VASCULAR GRAFT PROSTHESIS
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit pkwy; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit pkwy; south jordan UT 84095
• Manufacturer Contact: bryson heaton bsn.rn ; 1600 merit pkwy; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 18441102
• MDR Text Key: 331924257
• Report Number: 1721504-2024-00001
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00884450563908
• UDI-Public: 884450563908
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/15/2023

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 Operator: Health Professional
• Device Catalogue Number: SUPERHERO
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2023
• Initial Date FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1