MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS INC HYDROMARK BREAST BIOPSY SITE MARKER; BIOPSY SITE IDENTIFIER

Catalog Number	4010-03-09-T3
Medical Device Problem Code	Retraction Problem (1536)
Health Effect - Clinical Code	Abrasion (1689)
Date of Event	03/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by sales representative that during the procedure after the marker was deployed the patient passed out.The probe was quickly retracted out but a spring was caught in the breast.While removing the spring the technician rammed her knuckle into the probe.The technician had to go to the emergency room for bbf protocol.
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 the patient passed out at the end of the procedure with the probe was still in the patients breast.The user quickly retracted the probe causing the spring to be caught.While pulling the spring out of the breast the technician jammed her knuckle into the probe.The technician did puncture her hand on the probe causing a wound on her hand.The technician visited the emergency room for blood and body fluid exposure.The technician has reported that her knuckle is still swollen but is doing fine.

• Brand Name: HYDROMARK BREAST BIOPSY SITE MARKER
• 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: 14079740
• Report Number: 3008492462-2022-00004
• Device Sequence Number: 16668183
• Product Code: NEU
• UDI-Device Identifier: 10841911100147
• UDI-Public: (01)10841911100147(17)240620(10)F12127108D
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121113
• 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: Company Representative
• 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: 06/20/2024
• Device Catalogue Number: 4010-03-09-T3
• Device Lot Number: F12127108D
• 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: 03/14/2022
• Initial Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2021
• 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