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

Model Number	00884450386521
Medical Device Problem Codes	Fracture (1260); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/23/2020
Type of Reportable Event	Malfunction
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 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.
Additional 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
• Common Device Name: VENOUS OUTFLOW COMPONENT - VASCULAR GRAFT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan UT 84095
• MDR Report Key: 10786096
• Report Number: 1721504-2020-00091
• Device Sequence Number: 19589458
• Product Code: DSY
• UDI-Device Identifier: 00884450386521
• UDI-Public: 00884450386521
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• PMA/510(K) Number: K172637
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 10/23/2020
• Supplement Date Received by Manufacturer: 11/09/2020
• Initial Report FDA Received Date: 11/04/2020
• Supplement Report FDA Received Date: 11/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1