MAUDE Adverse Event Report: MERIT MEDICAL - ALISO VIEJO SCOUT; MARKER, RADIOGRAPHIC, IMPLANTABLE

Model Number SSR75-01

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

Patient Problem Hematoma (1884)

Event Date 05/08/2020

Event Type  Injury  

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.

Event Description

On april 6, 2021, a merit employee conducted a cer literature search for the scout product family.The study (see citation below) reports adverse events related to the savi scout system.One event alleges that a patient developed a postoperative haematoma that required surgical evacuation after placement of a scout reflector and use of the savi scout system.Study: tayeh, salim, samantha muktar, jennifer heeney, michael j.Michell, nicholas perry, tamara suaris, david evans, anmol malhotra, and kefah mokbel."reflector-guided localization of non-palpable breast lesions: the first reported european evaluation of the savi scout® system." anticancer research 40, no.7 (2020): 3915-3924.

• Brand Name: SCOUT
• Type of Device: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): MERIT MEDICAL - ALISO VIEJO; 6 journey unit 125; aliso viejo CA 92656
• Manufacturer (Section G): MERIT MEDICAL - ALISO VIEJO; 6 journey unit 125; aliso viejo CA 92656
• Manufacturer Contact: bryson heaton ; 1600 merit parkway; south jordan, UT 84095 ; 8012084662
• MDR Report Key: 12160286
• MDR Text Key: 261290245
• Report Number: 2032338-2021-00012
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00852205006024
• UDI-Public: 00852205006024
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K181007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SSR75-01
• Device Catalogue Number: SSR75-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2021
• 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