MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC MAMMOMARK; BIOPSY SITE IDENTIFIER

Model Number	MMK0803
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The sales representative reported that during procedure the sheath came out with clip into breast tissue.The procedure was completed but the patient is having excisional surgery to remove radial scar along with the sheath.
Additional Manufacturer Narrative
The mammomark biopsy site identifiers are composed of a bioresorbable collagen plug embedded with a non-resorbable permanent radiopaque titanium wire marker.Each mammomark site identifier is packaged sterile in a flexible, disposable applicator for single patient use.The packaging also includes a sterile marker sheath at the distal end of the applicator shaft designed to retain the marker within the applicator shaft prior to use with mammotome revolve biopsy probes.The sales representative reported that during procedure the sheath came out with clip into breast tissue.The procedure was completed but the patient is having excisional surgery to remove radial scar along with the sheath.We reached out to the reporter for additional information and the patient is scheduled to have surgery at the end of the month to get the sheath removed.The mammomark instructions for use instruct the user to "remove marker sheath prior to insertion into probe.Based on the available information this event did not occur as a result of device malfunction.
Additional Manufacturer Narrative
The initial report was submitted on (b)(6) 2023.The purpose of this follow up report is to correct g6 in the initial report which should have the "initial" box checked.D4 serial & lot number sections were corrected.The number was removed from serial number section and added to the lot number section.In addition, e1 contact information was updated to contain the correct contact name and email address.

• Brand Name: MAMMOMARK
• Common Device Name: BIOPSY SITE IDENTIFIER
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS INC; 300 e business way fifth floor; cincinnati OH 45241
• Manufacturer (Section G): DEVICOR MEDICAL PRODUCTS DE MEXICO; sor juanaines de la cruz; #20152 4-b; parque industrial, tijuana 22440 ; MX 22440
• Manufacturer Contact: vivian boyd ; 300 e business way fifth floor; cincinnati, OH 45241
• MDR Report Key: 16539449
• Report Number: 3008492462-2023-00006
• Device Sequence Number: 12542214
• Product Code: NEU
• UDI-Device Identifier: 00841911100492
• UDI-Public: (01)00841911100492(17)240204(10)F12230357D
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K082278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2024

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 Expiration Date: 02/04/2024
• Device Model Number: MMK0803
• Device Lot Number: F1223057D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/16/2023
• Supplement Date Received by Manufacturer: 02/16/2023
• Initial Report FDA Received Date: 03/14/2023
• Supplement Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• 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: Other
• Patient Sex: Unknown