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

Model Number	MAM3001
Medical Device Problem Code	Device Damaged by Another Device (2915)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The mammomark biopsy site identifier is intended for use after an open surgical or percutaneous breast biopsy procedure to the biopsy site.The device is not available for analysis, which precludes a full investigation and analysis of the root cause.Our mammotome vacuum assisted biopsy probes contain extremely sharp edges along the aperture opening to effectively excise tissue.Removing the marker delivery system separately from the probe aperture once the spring is exposed creates the possibility of it catching on one of these edges.As a mitigation step to address this risk, we provide instructions within the instructions for use: directions: remove the delivery system and mammotome probe together as a single unit from the site, properly dispose and obtain images to confirm marker placement.Based on the patient consequence of an unintended piece of the device in the biopsy site, and the additional surgical procedure to remove, and pursuant to 21 cfr 803, we are submitting this medwatch report.
Event or Problem Description
Devicor medical products inc.Received a report from the affiliate stating, "during the procedure, confirmed that the tip of the inserter was left in breast from the mammo mark 11 ref# mam3001 11g marker".The tip has not yet been removed from the patient.This patient will be scheduled for a more extensive surgery in the future.As of october 26, the patient had not experienced any complications.This has been documented as report # (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: 8055703
• Report Number: 3008492462-2018-00082
• Device Sequence Number: 1654322
• Product Code: NEU
• UDI-Device Identifier: 00841911101598
• UDI-Public: (01)00841911101598(17)190801(10)F11805202D
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K082278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/16/2018

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: 08/01/2019
• Device Model Number: MAM3001
• Device Catalogue Number: MAM3001
• Device Lot Number: F11805202D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2018
• Initial Report FDA Received Date: 11/09/2018
• 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: Other; Required Intervention