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

Model Number MAM3008

Device Problem Cut In Material (2454)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/01/2013

Event Type  Injury  

Event Description

A copy of medwatch report, (b)(4), was received from the (b)(4) at devicor on (b)(4) 2013.The report noted that the customer reported on (b)(6) 2013, that during an outpatient stereotactic procedure on (b)(6) 2013, for breast biopsy, the tip of the biopsy site marker was cut by the biopsy needle upon removing the sheath of the site marker.The report also noted that intervention was required.

Manufacturer Narrative

(b)(4).The device was not returned for investigation.Therefore, neither a comprehensive investigation, nor a definitive conclusion could be performed regarding this specific event.However, 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 fl; cincinnati OH 45241
• Manufacturer (Section G): DEVICOR MEDICAL PRODUCTS DE MEXICO S; de rl de cv, sor juana ines dela cruz; #20152 4-b, parque indust; chilpanciogo, tijuana ; MX
• Manufacturer Contact: 300 e-business way; fifth fl; cincinnati, OH 45241 ; 5138649178
• MDR Report Key: 3673998
• MDR Text Key: 4346258
• Report Number: 3008492462-2014-00003
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2014
• Device Model Number: MAM3008
• Device Catalogue Number: MAM3008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/17/2013
• Distributor Facility Aware Date: 10/01/2013
• Device Age: 15 MO
• Date Manufacturer Received: 12/27/2013
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2012
• 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): Required Intervention