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 07/01/2016

Event Type  Injury  

Manufacturer Narrative

The device has not returned for analysis at this time, which precluded a full investigation and analysis of the root cause.However, based on information received from the customer the event occurred as a result of user error.Tip shear has been identified as a potential risk whenever the applicator shaft is removed separately through the biopsy probe once it has been positioned in the probe aperture for marker deployment.Our mammotome vacuum assisted biopsy probes contain extremely sharp edges along the aperture opening to effectively excise tissue.Removing the applicator shaft once it is exposed to the probe aperture creates the possibility of the applicator catching on one of these edges and shearing.As a mitigation step to address this risk, we provide warnings and precaution language and instruction within the instructions for use: warning: failure to align the mammomark applicator as specified may result in improper deployment of the collagen plug and possible tip shear.Warning #10: remove the mammomark applicator and the mammotme biopsy probe together as a single unit from the site and obtain images to confirm marker placement.Retraining was conducted following the event.Follow up with the customer revealed that the patient has a papilloma and the tip will be removed at the time of the surgery.The surgery has not been scheduled at the time of this report.However, due to the subsequent procedure and pursuant to 21 cfr 803 we are submitting this medwatch report.

Event Description

The sales rep reported a tip shear has occurred.The radiologist pulled out the tm alone instead of all as one with the probe.The patient was previously scheduled to have surgery and the sheared tip will be removed at that time.

• 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: 5826671
• MDR Text Key: 50574936
• Report Number: 3008492462-2016-00031
• 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: 07/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2017
• Device Model Number: MAM3008
• Device Catalogue Number: MAM3008
• Device Lot Number: F11608501D1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/01/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/15/2016
• 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