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

Model Number	MAM3001
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The mammomark biopsy site identifier is a 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.However, this failure mode is identified in the risk management file and will occur at the end of the procedure and involves the marker tip physically breaking.The failure mode involves the tip of a side deploy marker shearing on the cutter of a disposable probe and separating from the body of the marker.Should this failure mode occur, there is a chance the broken marker tip may be left in the patient's breast.Medical intervention is required to remove the sheared tip.Based on patient consequences of unintended piece of the device of the device left in the biopsy site, and the additional surgical procedure to remove, and purusant to 21 cfr 803.We are submitting this medwatch report.
Event or Problem Description
It was reported by the sales rep that during an ultrasound procedure they had an issue where the marker would not release from the plunger so he rotated it and it released however he then tried to remove the marker introducer and it became "stuck".He pushed forward and it seemed to release and he removed the marker.The doctor kept the plunger depressed while he pulled back on the marker most likely.Upon follow up they say the tip shear next to the clip.This event is documented in our system as complaint#(b)(4).

• Brand Name: MAMMOMARK
• Common Device Name: BIOPSY SITE IDENTIFIER
• Manufacturer (Section D): DEVICOR MEDICAL PRODUCTS, INC; 300 e. business way; fifth floor; cincinnati OH 45241
• MDR Report Key: 10982885
• Report Number: 3008492462-2020-00013
• Device Sequence Number: 16341603
• Product Code: NEU
• UDI-Device Identifier: 10841911101595
• UDI-Public: (01)10841911101595(17)211204(10)F12022532D
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K082278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/09/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/04/2021
• Device Model Number: MAM3001
• Device Catalogue Number: MAM3001
• Device Lot Number: F12022532D
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2020
• Initial Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention