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

Model Number 4010-01-11-T3

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

The hydromark breast biopsy site marker is used to mark tissue during a percutaneous breast biopsy procedure, be visible under ultrasound for at least 6 week, and be permanently visible by x-ray and mri.The device has not been returned for evaluation, which prevents a full investigation and analysis of a root cause at this time.However, this failure mode has been identified in the risk management file for the effects of potential foreign body reaction with a potential for injury to the patient and/or user.Follow up medical intervention may be necessary.Although it could not be concluded that our device caused or contributed to this event, through evaluation by our medical advisor on similar events, this has been determined to be reportable pursuant to 21 cfr 803.

Event Description

Devicor medical products, inc.Received a report from the distributor stating, "marker clip was inserted in (b)(6) 2018.Patient follow up in (b)(6) 2019 showed a new nodule around the clip.Suspected to be a reaction to the gel marker clip.Marker is still in patient's breast and not removed".This had been documented in our system as report # (b)(4).

• Brand Name: HYDROMARK 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, INC.; 300 e. business way; fifth floor; cincinnati OH 45241
• Manufacturer Contact: jill burnett ; 300 e. business way; fifth floor; cincinnati, OH 45241
• MDR Report Key: 8959919
• MDR Text Key: 158978968
• Report Number: 3008492462-2019-00042
• Device Sequence Number: 1
• Product Code: NEU
• UDI-Device Identifier: 00841911101437
• UDI-Public: (01)00841911101437(17)200704(10)200042056
• Combination Product (y/n): N
• PMA/PMN Number: K060769
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/04/2020
• Device Model Number: 4010-01-11-T3
• Device Catalogue Number: 4010-01-11-T3
• Device Lot Number: 200042056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other