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

Model Number	MAM3001
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/10/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The hydromark 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 instruction for use and deployment guide, provided with the device, must be followed to avoid the applicator from shearing.In accordance with iso 13485:2016 and iso 10993-1 requirements, the mammomark¿ biopsy site identifier devices have been tested for biocompatibility for their intended use and patient contact duration per iso 10993-1.The collagen marker and titanium clip are the only mammomark components classified as having "permanent patient contact." components of the applicator are classified as "limited patient contact" and qualified for the intended use during the procedure.Applicator materials are considered medical-grade but have not been evaluated for permanent implantation.As with any implanted device, the implant site should be monitored for any signs of irritation or reaction following the surgical procedure.It was reported that while doctor was inserting the marker clip, the sheath sheared and when surgeon took out sheath, a piece was left inside the breast.The foreign body was seen on the mammogram.The patient was then transferred to a room and the foreign body was removed.To date there has been no information of perrmanent impairment of a body function or permanent damage to a body structure, or a condition that necessitates an unexpected medical or surgical intervention to prevent such a disease, disorder or abnormal physical state or permanent impairment or damage.
Event or Problem Description
It was reported by the affiliate that while doctor was inserting the marker clip, the sheath sheared and when surgeon took out sheath, a piece was left inside.Foreign body was able to be seen by mammogram.Patient transferred to room for removal of foreign body with fluro.

• 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
• Manufacturer (Section G): DEVICOR MEDICAL PRODUCTS DE MEXICO; sor juanaines de la cruz; #20152 4-b; parque industrial, tijuana 22440 ; MX 22440
• Manufacturer Contact: vivian rodriguez ; 300 e business way fifth floor; cincinnati, OH 45241
• MDR Report Key: 14079703
• Report Number: 3008492462-2022-00006
• Device Sequence Number: 16677995
• Product Code: NEU
• UDI-Device Identifier: 00841911101598
• UDI-Public: (01)00841911101598(17)230226(10)F12134344D
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K082278
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/26/2023
• Device Model Number: MAM3001
• Device Catalogue Number: MAM3001
• Device Lot Number: F12134344D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2022
• Initial Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown