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

Model Number MAM3002

Device Problem Device Damaged by Another Device (2915)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/20/2016

Event Type  Injury  

Manufacturer Narrative

The device has not been return at this time, so specific device evaluation cannot be performed.However, based on our knowledge of the device design, its prescribed use, and customer feedback, the most likely scenario is that the user 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 biopsy probes contain extremely sharp edges along the aperture opening to effectively excise tissue.Removing the applicator shaft after exposure 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, we provide warnings and precaution language and instruction within the instructions for use: warning: failure to align the mammomark applicator as specified may result in improper deployment of the collagen plug and possible tip shear.Warning #10: remove the mammomark applicator and the mammotome biopsy probe together as a single unit from the site and obtain images to confirm marker placement.Attempts to contact the treating physician 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 during the us biopsy with legacy ex, the physician deployed mammomark2 biopsy site identifier (mam3002) following biopsy and then removed the marker deployment device from the probe.During marker confirmation mammogram it was seen that the physician had sheared off the tip of the marker deployment device and it was left in the breast along with the marker.

• 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: 5654638
• MDR Text Key: 45192547
• Report Number: 3008492462-2016-00021
• 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: 04/20/2016

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 Model Number: MAM3002
• Device Catalogue Number: MAM3002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2016
• Initial Date FDA Received: 05/13/2016
• Was Device Evaluated by Manufacturer?: No
• 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