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

Model Number 00884450310151

Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/19/2020

Event Type  malfunction  

Manufacturer Narrative

The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.

Event 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.

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
• Type of Device: HERO GRAFT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan,, ut
• MDR Report Key: 9857530
• MDR Text Key: 198856386
• Report Number: 1721504-2020-00014
• Device Sequence Number: 1
• Product Code: DSY
• UDI-Device Identifier: 00884450310151
• UDI-Public: 00884450310151
• Combination Product (y/n): N
• PMA/PMN Number: K124039
• 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: 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
• Device Operator: 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 Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/19/2020
• Supplement Dates Manufacturer Received: 06/02/2020
• Supplement Dates FDA Received: 06/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PCI BALLOON