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

Model Number MAM3001

Device Problem Mechanical Problem (1384)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/17/2020

Event Type  malfunction  

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 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
• 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: jack cummings ; 300 e business way; fifth floor; cincinnati, OH 45241
• MDR Report Key: 10982885
• MDR Text Key: 220694288
• Report Number: 3008492462-2020-00013
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 10841911101595
• UDI-Public: (01)10841911101595(17)211204(10)F12022532D
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/04/2020
• 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
• Patient Outcome(s): Required Intervention