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

Catalog Number HERO1001

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/26/2016

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return.The complaint could not be confirmed.The root cause is unknown.A review of the complaint data base and device history record could not be performed since the lot number was not provided.

Event Description

Dr.(b)(6) performed a de-clot procedure using a 6x8mm balloon.He then took a final image at the end of the procedure and determined that the outflow component had separated from the graft and migrated distally during the procedure.The physician then had to retrieve the component by accessing the femoral vein and successfully snared the device from the patient.The graft remained open and the patient is fine.The outflow component was then replaced successfully.The patient's dialysis schedule was not delayed.

• Brand Name: HERO VENOUS OUTFLOW COMPONENT
• Type of Device: HERO®.VENOUS OUTFLOW COMPONENT.
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 w. merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 w. merit parkway; south jordan UT 84095
• Manufacturer Contact: casey hughes ms, cqe ; 1600 w. merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 6044905
• MDR Text Key: 57980251
• Report Number: 1721504-2016-00196
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2016

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?: Yes
• Device Operator: Physician
• Device Catalogue Number: HERO1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/20/2016
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention