MAUDE Adverse Event Report: MERIT MEDICAL SYSTEMS INC. SCOUT DELIVERY NEEDLE AND REFLECTOR; INTERNAL TISSUE MARKER

Model Number	SSR75-01
Medical Device Problem Code	No Audible Prompt/Feedback (2282)
Health Effect - Clinical Codes	Emotional Changes (1831); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	05/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect reflector is not expected to return for evaluation.A follow up will be submitted when the evaluation is complete.
Event or Problem Description
"the reporter alleges that during an excisional biopsy procedure, the attending physician was advised of a reflector's location by the radiologist.Prior to prepping the patient, the physician surveyed the breast with a backup guide in attempts to locate the reflector.Several beeps were received repeatedly.The physician used an ultrasound probe to try and locate the reflector but was unsuccessful.The physician decided to make an incision.The guide was placed within the patient's breast, no signal could be heard.Moving the guide around, the physician was eventually able to hear a cadence, on the left breast at the lower inner quadrant.The physician began forming a large ball with the cutting bovie to ensure that the reflector would be removed with the specimen.Once the specimen was out of the body, a cadence was heard.The physician placed the guide back in the patient and heard a cadence in a position where there was no longer any breast tissue.The physician removed another specimen from the patient but could not locate the reflector.The physician put the guide back in the cavity where the specimen came out and heard a steady consistent cadence.The physician placed the guide on the opposite side of the breast and received a steady cadence.The physician went back to the patient and cut out another very small specimen.After the specimen was removed.Again, the physician could not locate the reflector with the guide.There were multiple occasions where the cadence and depth did not lead to where the reflector was located.The physician was concerned that a patient ended up with a partial mastectomy while searching for a reflector.The procedure was completed without locating the reflector.The guide used for this procedure was reliable.When the guide was not in use, there was no interference.The patient did not have anything on them that could have interfered with the probe.
Additional Manufacturer Narrative
The suspect device was not returned for investigation.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.Should the device be returned at a later date, the investigation will be re-opened.

• Brand Name: SCOUT DELIVERY NEEDLE AND REFLECTOR
• Common Device Name: INTERNAL TISSUE MARKER
• Manufacturer (Section D): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; UT 84095
• Manufacturer (Section G): MERIT MEDICAL SYSTEMS INC.; 1600 merit parkway; UT 84095
• Manufacturer Contact: bryson heaton bsn,rn. ; 1600 merit parkway; 8012084662
• MDR Report Key: 14438454
• Report Number: 2032338-2022-00002
• Device Sequence Number: 5202981
• Product Code: NEU
• UDI-Device Identifier: 00852205006024
• UDI-Public: 00852205006024
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K141318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2022

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: SSR75S-01
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2022
• Supplement Date Received by Manufacturer: 07/11/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Disability
• Patient Sex: Female