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

Model Number MAM3008

Device Problem Device Damaged by Another Device (2915)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/06/2018

Event Type  Injury  

Manufacturer Narrative

The mammomark biopsy site identifier is intended for use after an open surgical or percutaneous breast biopsy procedure to 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.Removing the marker delivery system separately from the probe aperture 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: directions: remove the delivery system and mammotome probe together as a single unit from the site, properly dispose and obtain images to confirm marker placement.Based on the patient consequence of an unintended piece of the device in the biopsy site, and the additional surgical procedure to remove, and pursuant to 21 cfr 803, we are submitting this medwatch report.

Event Description

It was reported by the sales rep that during the procedure, post right-breast stereotactic biopsy, there was a failure of the tissue marker to deploy correctly.The plastic sheath broke off in the breast.The retained piece was visualized during post imaging.

• 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: 7361702
• MDR Text Key: 103173195
• Report Number: 3008492462-2018-00023
• 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: user facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2019
• Device Model Number: MAM3008
• Device Catalogue Number: MAM3008
• Device Lot Number: F11731392D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/31/2017
• 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
• Patient Age: 53 YR