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

Model Number MMK0803

Device Problem Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2018

Event Type  malfunction  

Manufacturer Narrative

The mammomark biopsy site identifier is sterile, single use device intended for use after an open surgical or percutaneous breast biopsy procedure to mark the biopsy site.The device has not been returned for analysis, which precludes a full investigation.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 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: *remove the mammomark applicator and the mammotome biopsy probe together as a single unit from the site and obtain images to confirm marker placement.No additional information about the patient is known at this time.Based on the potential for a unintended piece of the device to be left in the biopsy site, and the likely additional surgical procedure to remove, and pursuant to 21 cfr 803, we are submitting this medwatch report.

Event Description

The sales rep reported that during deployment of a mammomark marker through 8g revolve, the clip was reported to have met severe resistance during attempt.When marker would not deploy doctor tried to remove the applicator out the back of the probe, which also resulted in resistance.She then backed the needle out of the breast and when trying to remove applicator tip/marker broke within needle.She proceeded to free hand deploy another marker at proper depth by using length of needle for reference.This time it worked and placement was accurate.Patient was reported to have bleeding more than normal.

• Brand Name: MAMMOMARK BIOPSY SITE IDENTIFIER
• Type of Device: BIOPSY SITE MARKER
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 e-business way; 5th floor; cincinnati OH 45241
• Manufacturer (Section G): DEVICOR MEDICAL PRODUCTS DE MEXICO; sor juana ines de la cruz; #20152 4-b, parque industrial; tijuana, baja california 22440 ; MX 22440
• Manufacturer Contact: shawna rose ; 300 e-business way; 5th floor; cincinnati, OH 45241 ; 5138649178
• MDR Report Key: 7274453
• MDR Text Key: 100452895
• Report Number: 3008492462-2018-00010
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2019
• Device Model Number: MMK0803
• Device Catalogue Number: MMK0803
• Device Lot Number: F11728486D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2018
• Initial Date FDA Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other