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

Model Number	MAM3008
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/15/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mammomark biopsy site identifier is a sterile, single use device intended for use after an open surgical or percutaneous breast biopsy procedure to mark the biopsy site.The device is not available for analysis, which precludes a full investigation and analysis of the root cause.However, this failure mode is identified in the risk management file and will occur at the end of the procedure and involves the marker tip physically breaking.The failure mode involves the tip of a side deploy marker shearing on the cutter of a disposable probe and separating from the body of the marker.Should this failure mode occur, there is a chance the broken marker tip may be left in the patient's breast.Current ifu lists this failure mode as a potential adverse event if device is misused.Based on patient consequences of unintended piece of the device of the device left in the biopsy site, we are submitting this medwatch report.
Event or Problem Description
It was reported by the affiliate that during a clip placement/ biopsy site marking procedure at the end of the procedure, the radiologist tried to place a biopsy marker.But the marker guide extremity broke inside the patient's breast leaving a 16mm debris in the breast.This event is documented in our system as (b)(4).

• 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
• MDR Report Key: 11654167
• Report Number: 3008492462-2021-00006
• Device Sequence Number: 19706789
• Product Code: NEU
• UDI-Device Identifier: 10841911100444
• UDI-Public: (01)10841911100444(17)220421(10)F12043206D
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K082278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/12/2021

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 Expiration Date: 04/21/2022
• Device Model Number: MAM3008
• Device Catalogue Number: MAM3008
• Device Lot Number: F12043206D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 04/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1