MAUDE Adverse Event Report: MERIT MEDICAL SYSTEM IRELAND ONE SNARE®; DEVICE, PERCUTANEOUS RETRIEVAL

Model Number 00884450094877

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

Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969); Great Vessel Perforation (2152)

Event Date 06/01/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to pmcf data, an account alleges that while retrieving a stent, from the peripheral vasculature, of an adult female, the patient experienced - stroke, myocardial infarction, and vessel perforation; however, no additional treatment were required.No additional details available.

Manufacturer Narrative

The suspect device was not returned for investigation.The complaint could not be confirmed.The root cause could not be determined.The device history record was reviewed, and no exception documents were found.A search of the complaint database was performed and no similar complaints for this lot number were identified.Should the device be returned later, the investigation will be re-opened.

• Brand Name: ONE SNARE®
• Type of Device: DEVICE, PERCUTANEOUS RETRIEVAL
• Manufacturer (Section D): MERIT MEDICAL SYSTEM IRELAND; parkmore business park west; ballybrit, galway ; EI
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 15114710
• MDR Text Key: 296712147
• Report Number: 9616662-2022-00015
• Device Sequence Number: 1
• Product Code: MMX
• UDI-Device Identifier: 00884450094877
• UDI-Public: 00884450094877
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 00884450094877
• Device Catalogue Number: ONE1001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/07/2022
• 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): Life Threatening
• Patient Sex: Female