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

Catalog Number HERO1002/B

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 10/16/2018

Event Type  Injury  

Manufacturer Narrative

The device is expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during an arteriovenous graft implant procedure, the last 17 cm of the arterial graft at the patient's anastomosis was found weeping.The graft had not matured yet and had not been used for patient dialysis.A new arteriovenous graft was sutured onto the arterial graft component.

Manufacturer Narrative

The suspect device was returned for evaluation.The device was examined visually and functional testing was performed.The complaint is confirmed.The root cause was unable to be determined.A review of the device history record was performed and no exception documents were found.A review of the complaint database was performed and no similar complaints for this lot number were found.

• Brand Name: HERO ARTERIAL GRAFT
• Type of Device: CATHETER, INTRAVASCULAR
• 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: 8078016
• MDR Text Key: 127385657
• Report Number: 1721504-2018-00120
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K124039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: HERO1002/B
• Device Lot Number: H1330335
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/03/2018
• 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; Required Intervention