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

Model Number MAM3008

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/04/2013

Event Type  malfunction  

Event Description

The sales rep reported that two doctors at same account indicated they have both had recent deployment issues with difficult or no marker coming out with one instance resulting in a tip shear.Physician indicated the sheared tip remains in the patient, who is doing fine at this time.

Manufacturer Narrative

(b)(4).Investigation summary: the device was not returned for investigation; therefore, a definitive conclusion could not be reached regarding this specific event.Based on our knowledge of the device design and its prescribed use, 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 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.

• 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: 3554511
• MDR Text Key: 4103964
• Report Number: 3008492462-2013-00033
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAM3008
• Device Catalogue Number: MAM3008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/04/2013
• Initial Date FDA Received: 01/03/2014
• 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