MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. HERO ARTERIAL GRAFT; CATHETER

Catalog Number HERO1001

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/15/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The account alleges that during a percutaneous thrombectomy of a hemodialysis graft, the marker band detached within the patient.The physician had acquired hemodialysis graft access and had inserted an interventional guidewire distally through the patient's inferior vena cava under fluoroscopy.A compliant balloon was then inserted over the wire and introduced into the outflow component.The physician states that the balloon was not inflated near the marker band during procedure.The radiopaque marker band at the end of the venous outflow component [voc] detached and migrated over the guidewire towards the patient's groin.The physician then acquired antegrade femoral venous access, and a long introducer sheath was placed.The physician introduced a vascular snare device and successfully removed the marker band from the patient.

• Brand Name: HERO ARTERIAL GRAFT
• Type of Device: CATHETER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; south jordan, UT 84095
• Manufacturer Contact: katie swenson cqe,cba,cqpa. ; 1600 merit parkway; south jordan, UT 84095 ; 8012531600
• MDR Report Key: 7814955
• MDR Text Key: 241263876
• Report Number: 1721504-2018-00084
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/15/2018
• Initial Date FDA Received: 08/24/2018
• 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): Life Threatening; Required Intervention