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

Model Number	00884450310151
Medical Device Problem Codes	Material Separation (1562); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
The account alleges that during a thrombectomy procedure using a balloon to clear the excessive thrombus from the venous output component [voc], the distal ring on the voc device detached and migrated to the patient's lung.A new voc was placed for continued treatment.The patient tolerated the procedure well and remained asymptomatic.No additional procedures have been scheduled.
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.The complaint is confirmed.The root cause is attributed to the manufacturing process.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.Corrective action for this issue has been implemented via re-design of the product.

• Brand Name: HERO VENOUS OUTFLOW COMPONENT
• Common Device Name: HERO GRAFT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan,, ut
• MDR Report Key: 9857530
• Report Number: 1721504-2020-00014
• Device Sequence Number: 3307311
• Product Code: DSY
• UDI-Device Identifier: 00884450310151
• UDI-Public: 00884450310151
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K124039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2020

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 Model Number: 00884450310151
• Device Catalogue Number: HERO1001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2020
• Initial Date Received by Manufacturer: 02/19/2020
• Supplement Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 03/19/2020
• Supplement Report FDA Received Date: 06/19/2020
• 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: PCI BALLOON