MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. MAMMOMARK BREAST BIOPSY SITE MARKER

Model Number MMK1002

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/21/2018

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.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

Devicor medical products, inc.Received a user medwatch stating, "(b)(6) 2018 mammogram stereotactic right breast biopsy for indeterminate right breast microcalcifications, multiple passes were made under ultrasound guidance using a vacuum assisted 10-guage elite device.A titanium clip was placed at biopsy site.Specimen was sent to pathology for review.Microcalcifications were noted in the specimen radiograph.Post stereotactic biopsy right breast mammogram confirmed titanium clip was in the appropriate location.In addition, on the right mlo view, a 12x2.4 mm cylindrical structure, which likely corresponded to the radiopaque tip of the mammotome mark which sheared off during the procedure, located approx 7cm proximal to the titanium clip, superficially.The pt was informed of the sheared mammomark catheter tip and concurred with the surgeon's plan to leave the tip in place.The surgical pathology report revealed benign microcalcifications.The pt had no complaints of pain until (b)(6) 2018.On (b)(6) 2018, the pt underwent exploration and removal of foreign body in right breast under local anesthesia plus sedation.The tip of the mammotome was taken out and sent to pathology.On (b)(6) 2018 , the pt was seen in the surgery clinic and was doing well with well healing wounds.Dates of use: (b)(6) 2018.Diagnosis or reason for use: stereotactic right breast biopsy.The product was not compounded; the product was not over-the-counter".Report number mw5080699.This has been documented in our system as record # (b)(4).

• Brand Name: MAMMOMARK BREAST BIOPSY SITE MARKER
• Type of Device: BREAST BIOPSY SITE MARKER
• 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
• Manufacturer Contact: jill burnett ; 300 e. business way; fifth floor; cincinnati, OH 45241
• MDR Report Key: 8379864
• MDR Text Key: 137559744
• Report Number: 3008492462-2019-00011
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00841911101628
• UDI-Public: (01)00841911101628(17)181201(10)F11721481D
• 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: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2018
• Device Model Number: MMK1002
• Device Catalogue Number: MMK1002
• Device Lot Number: F11721481D
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/31/2017
• 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