MAUDE Adverse Event Report: MERIT MEDICAL SYSTEM EN SNARE; DEVICE, PERCUTANEOUS RETRIEVAL

Model Number 00884450452462

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/14/2020

Event Type  Injury  

Manufacturer Narrative

The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.

Event Description

The account alleges that during a vascular procedure, the tip of a vascular snare device detached within the patient at the junction between the three loops and shaft, when the nephrologist was trying to withdraw a central venous catheter from the patients femoral vein.A surgeon was consulted, and the foreign body was successfully retrieved via a surgical incision forceps.No additional consequences to report.

Manufacturer Narrative

The suspect device was returned for evaluation.The complaint was confirmed; however, the root cause could not be determined.A search of the complaint database was performed and no similar complaints for this lot number were found.The device history record was reviewed, and no exception documents were found.

• Brand Name: EN SNARE
• Type of Device: DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): MERIT MEDICAL SYSTEM; parkmore business park west; ballybrit, galway ; EI
• MDR Report Key: 10485338
• MDR Text Key: 214146727
• Report Number: 9616662-2020-00011
• Device Sequence Number: 1
• Product Code: MMX
• UDI-Device Identifier: 00884450452462
• UDI-Public: 00884450452462
• Combination Product (y/n): N
• PMA/PMN Number: K151497
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00884450452462
• Device Catalogue Number: EN2006020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2020
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: VAS-CATH DIALYSIS CATHETER - BARD
• Patient Outcome(s): Required Intervention