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

Catalog Number HERO1003

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation (2001)

Event Date 07/22/2016

Event Type  Injury  

Manufacturer Narrative

The suspect device is not expected to return for evaluation.Because the unit was not returned 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

The user reported that after using the dilator from the kit to insert a guidewire into the vessel that the wire kept buckling.After injecting contrast he found either a dissection or perforation of the distal external jugular vein.The physician did not use fluoroscopy to advance the wire.He left the sheath in and surgically repaired the damaged vessel.The physician chose to discontinue the placement of the graft.

• Brand Name: HERO ARTERIAL GRAFT
• Type of Device: CATHETER, INTRAVASCULAR
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS, INC; 1600 west merit parkway; south jordan UT 84095
• Manufacturer Contact: casey hughes, ms, cqe ; 1600 west merit parkway; south jordan, UT 84095 ; 8013164932
• MDR Report Key: 5870504
• MDR Text Key: 51922540
• Report Number: 1721504-2016-00145
• 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: Other
• Type of Report: Initial
• Report Date: 07/22/2016

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: HERO1003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/22/2016
• Initial Date FDA Received: 08/11/2016
• 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): Required Intervention