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

Model Number 00884450386521

Device Problems Fracture (1260); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/23/2020

Event Type  malfunction  

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 the implant of the hero device, upon removing the peel-away sheath the hub detached and the sheath was left in the body and moved down the ivc.The surgeon and the ir physician were able to retrieve the sheath from the ivc.No patient injury to report.

Manufacturer Narrative

The suspect device was not returned for evaluation.The complaint could not be confirmed.The root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: HERO
• Type of Device: VENOUS OUTFLOW COMPONENT - VASCULAR GRAFT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 10786096
• MDR Text Key: 214583058
• Report Number: 1721504-2020-00091
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00884450386521
• UDI-Public: 00884450386521
• Combination Product (y/n): N
• PMA/PMN Number: K172637
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

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 Expiration Date: 09/09/2022
• Device Model Number: 00884450386521
• Device Catalogue Number: HERO1001VOC/A
• Device Lot Number: H1913105
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/04/2020
• Supplement Dates Manufacturer Received: 11/09/2020
• Supplement Dates FDA Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1