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

Model Number MAM3008

Device Problem Use of Device Problem (1670)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/15/2021

Event Type  Injury  

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.Current ifu lists this failure mode as a potential adverse event if device is misused.Based on patient consequences of unintended piece of the device of the device left in the biopsy site, we are submitting this medwatch report.

Event Description

It was reported by the affiliate that during a clip placement/ biopsy site marking procedure at the end of the procedure, the radiologist tried to place a biopsy marker.But the marker guide extremity broke inside the patient's breast leaving a 16mm debris in the breast.This event is documented in our system as (b)(4).

• 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 juanaines de la cruz; #20152 4-b; parque industrial, 22440 ; MX 22440
• Manufacturer Contact: vivian rodriguez ; 300 e business way; fifth floor; cincinnati, OH 45241
• MDR Report Key: 11654167
• MDR Text Key: 249709254
• Report Number: 3008492462-2021-00006
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 10841911100444
• UDI-Public: (01)10841911100444(17)220421(10)F12043206D
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K082278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2022
• Device Model Number: MAM3008
• Device Catalogue Number: MAM3008
• Device Lot Number: F12043206D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/22/2020
• 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