MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. MAMMOTMARK BIOPSY SITE IDENTIFIER; BIOPSY SITE MARKER

Model Number MMK1001

Device Problem Device Damaged by Another Device (2915)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 10/24/2017

Event Type  Injury  

Manufacturer Narrative

The mammomark biopsy site identifier is sterile, single use device intended for use after an open surgical or percutaneous breast biopsy procedure to mark the biopsy site.The device is not available for analysis, which precludes a full investigation and analysis of the root cause.Our mammotome vacuum assisted biopsy probes contain extremely sharp edges along the aperture opening to effectively excise tissue.Activating the cutter once the spring is exposed creates the possibility of it catching on one of these edges.As a mitigation step to address this risk, we provide instructions within the instructions for use: caution: do not activate the probe cutter or other clinical functions while a marker is inserted in the probe.Follow up with the customer revealed that the patient has not had the tip removed.The doctor has been retrained on the proper procedure for device usage.Based on the patient consequence of unintended piece of the device in the biopsy site, and the likely additional surgical procedure to remove, and pursuant to 21 cfr 803, we are submitting this medwatch report.

Event Description

The sales rep reported that mammomark tip was sheared off in patients breast.The rad closed the aperture while marker was still in place.

• Brand Name: MAMMOTMARK BIOPSY SITE IDENTIFIER
• Type of Device: BIOPSY SITE MARKER
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC.; 300 e-business way; 5th 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; 5th floor; cincinnati, OH 45241 ; 5138649178
• MDR Report Key: 7053026
• MDR Text Key: 92768876
• Report Number: 3008492462-2017-00087
• 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: 10/27/2017

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: MMK1001
• Device Catalogue Number: MMK1001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 11/22/2017
• 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
• Patient Outcome(s): Other