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

Model Number MAM3001

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/29/2013

Event Type  malfunction  

Event Description

The sales rep reported that during the st biopsy, the 11g mammomark tip sheared off in the breast during removal.The clip deployed normally.During the removal of the marker introducer the plastic tip sheared off and remains in the patient's breast.

Manufacturer Narrative

(b)(4).Investigation summary: sales rep met with the rad week of december 9th to discuss event.It was confirmed that the doctor did not follow the ifu and removed the marker before removing the probe.The doctor informed the sales rep that she felt a little resistance when removing the marker and then rotated the aperture.After rotation, she removed the marker and discovered the tip had sheared off.Currently the tip remains in the patient's breast.The biopsy's results were benign so an additional procedure will be done to remove the tip.The device is with the account's risk management group, therefore, we are currently unable to evaluate the device itself to determine a definitive conclusion regarding this specific event.However, tip shear has been identified as a potential risk when attempting to remove the applicator shaft through the biopsy probe.Our mammotome vacuum assisted biopsy probes contain extremely sharp edges along the aperture opening to effectively excise tissue.Removing the applicator shaft creates the possibility of the applicator catching on one of these edges and shearing.As a mitigation step to address this risk, we provide contraindication language and instruction within the instructions for use: see scanned page.

• Brand Name: MAMMOMARK BIOPSY IDENTIFIER
• Type of Device: TISSUE MARKER
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 e-business way; fifth floor; cincinnati OH 45241
• Manufacturer (Section G): DEVICOR MEDICAL PRODUCTS DE MEXICO S DE RL DE CV; sor juana ines de la cruz #20152 4-b,; parque industrial, chilpancingo; tijuana ; MX
• Manufacturer Contact: 300 e-business way; fifth floor; cincinnati, OH 45241 ; 5138649178
• MDR Report Key: 3554513
• MDR Text Key: 4103965
• Report Number: 3008492462-2013-00031
• 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: 12/23/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAM3001
• Device Catalogue Number: MAM3001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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