MAUDE Adverse Event Report: CIANNA MEDICAL INC. / MERIT MEDICAL SYSTEMS, INC. SAVI SCOUT REFLECTOR & DELIVERY SYSTEM; MARKER, RADIOGRAPHIC, IMPLANTABLE

Lot Number ML04900

Device Problems Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/13/2020

Event Type  malfunction  

Event Description

Patient was undergoing breast savi scout placement when the reflector did not deploy properly from the savi scout device.The reflector was stuck in the end of the needle.Second device obtained and reflector deployed without incident fda safety report id# (b)(4).

• Brand Name: SAVI SCOUT REFLECTOR & DELIVERY SYSTEM
• Type of Device: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): CIANNA MEDICAL INC. / MERIT MEDICAL SYSTEMS, INC.
• MDR Report Key: 10065054
• MDR Text Key: 191401758
• Report Number: MW5094526
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: ML04900
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 68 YR