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

Model Number	SSR75-01
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Wound Dehiscence (1154)
Date of Event	05/08/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
On (b)(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 (on full anticoagulation due to factor v leiden genotype) developed a partial wound dehiscence after placement of a scout reflector and use of the savi scout system.The wound was sutured under local anaesthesia in the outpatient setting.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
• Common Device Name: MARKER, RADIOGRAPHIC, IMPLANTABLE
• Manufacturer (Section D): MERIT MEDICAL - ALISO VIEJO; 6 journey unit 125; aliso viejo CA 92656
• MDR Report Key: 12160288
• Report Number: 2032338-2021-00013
• Device Sequence Number: 3490764
• Product Code: NEU
• UDI-Device Identifier: 00852205006024
• UDI-Public: 00852205006024
• Combination Product (Y/N): Y
• Initial Reporter Country: UK
• PMA/510(K) Number: K181007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/06/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: SSR75-01
• Device Catalogue Number: SSR75-01
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention