MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. MERIT ADVANCE®; TROCAR

Model Number 00884450008997

Device Problems Fracture (1260); Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/29/2022

Event Type  Injury  

Event Description

The account alleges that the angiographic needle snapped from its hub during ct guided biopsy and aspiration.The needle was not retrievable.It was decided to refer the patient to the cardio-thoracic specialist for removal.

Manufacturer Narrative

The suspect device is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.

Manufacturer Narrative

The suspect device was not returned 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.

• Brand Name: MERIT ADVANCE®
• Type of Device: TROCAR
• 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: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 14778492
• MDR Text Key: 294535473
• Report Number: 1721504-2022-00051
• Device Sequence Number: 1
• Product Code: DRC
• UDI-Device Identifier: 00884450008997
• UDI-Public: 00884450008997
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/13/2022

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 Model Number: 00884450008997
• Device Catalogue Number: AD19U71W
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 06/22/2022
• Supplement Dates Manufacturer Received: 07/12/2022
• Supplement Dates FDA Received: 07/13/2022
• 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