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

Catalog Number HERO1001

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/04/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Account alleges that a long-standing hemodialysis access graft patient from another hospital was diagnosed with a separated venous outflow component [voc].The account states that the voc had separated into two pieces within the patient's superior vena cava [svc].The distal part of the voc was identified within the patient's heart and was removed through the svc via thoracic surgery.The account noted that the voc was pinched between the patient's clavicle and the first rib.An additional surgical procedure may be necessary to remove the proximal voc in the future.

• Brand Name: HERO VENOUS OUTFLOW COMPONENT
• Type of Device: VENOUS OUTFLOW COMPONENT
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC.; 1600 w merit parkway; south jordan 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC.; 1600 w merit parkway; south jordan 84095
• Manufacturer Contact: katie swenson, cqe, cba, cqpa ; 1600 w merit parkway; south jordan 84095 ; 8012081600
• MDR Report Key: 7685377
• MDR Text Key: 113893225
• Report Number: 1721504-2018-00068
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: HERO1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2018
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention