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

Model Number MMK0803

Device Problem Device Damaged by Another Device (2915)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/15/2016

Event Type  Injury  

Manufacturer Narrative

The device has not yet been returned for evaluation, which prevented a complete investigation and analysis.However, based on our knowledge of the device and its prescribed use, the most likely scenario is that the user rotated the marker applicator and/or removed the marker applicator separately from the biopsy probe.Tip shear has been identified as a potential risk whenever the applicator shaft is removed separately through the biopsy probe once it has been positioned in the probe aperture for marker deployment.Our mammotome vacuum assisted biopsy probes contain extremely sharp edges along the aperture opening to effectively excise tissue.Removing the applicator shaft once it is exposed to the probe aperture creates the possibility of the applicator catching on one of these edges and shearing.As a mitigation step to address this risk, step 13 of the ifu provides the following instruction: remove the mammomark applicator and the mammotome revolve biopsy probe together as a single unit from the site and obtain images to confirm marker placement.Attempts to contact the customer for additional event information and patient follow up care have been unsuccessful.However, due to the potential for a subsequent procedure or other treatment intervention, we are submitting this medwatch report.

Event Description

The sales rep reported that the rad had trouble placing the marker and attempted to remove the marker from the probe causing the tip to shear off into the breast.

• Brand Name: MAMMOMARK
• Type of Device: 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 juana ines de la cruz; #20152 4-b, parque industrial; tijuana, baja california 22440 ; MX 22440
• Manufacturer Contact: shawna rose ; 300 e-business way; fifth floor; cincinnati, OH 45241 ; 5138649178
• MDR Report Key: 5420031
• MDR Text Key: 37797902
• Report Number: 3008492462-2016-00005
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/15/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2016
• Device Model Number: MMK0803
• Device Catalogue Number: MMK0803
• Device Lot Number: F115232211
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/15/2016
• Initial Date FDA Received: 02/09/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/02/2015
• 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