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

Model Number	00884450452462
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	08/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has been returned for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem 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.
Additional 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
• Common Device Name: DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): MERIT MEDICAL SYSTEM; parkmore business park west; ballybrit, galway ; EI
• MDR Report Key: 10485338
• Report Number: 9616662-2020-00011
• Device Sequence Number: 19480702
• Product Code: MMX
• UDI-Device Identifier: 00884450452462
• UDI-Public: 00884450452462
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151497
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/17/2020
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 09/02/2020
• Supplement Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: VAS-CATH DIALYSIS CATHETER - BARD
• Outcome Attributed to Adverse Event: Required Intervention