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

Model Number 4010-01-08-T4

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/26/2017

Event Type  malfunction  

Manufacturer Narrative

The hydromark breast biopsy site marker is used to mark tissue during a percutaneous breast biopsy procedure, visible under ultrasound for at least 6 weeks, and be permanently visible by x-ray and mri.One 4010-01-08-t4 hydromark was received on 5/30/2017 and investigated on 6/2/2017.The device was received in good condition.The device shows signs of being used in a procedure.The fixed ramp is missing from the device and was not returned thus preventing a full investigation or determining root cause.The device history records were reviewed and there were no non-conformances that would relate to this failure.It was confirmed that the pink plastic pledget (fixed ramp) was found on the tip of the probe and not left in the biopsy site.However, as the occurrence has the potential to result in patient consequence with the need for surgical intervention or other form of treatment, and pursuant to 21 cfr 803, we are submitting this medwatch report.

Event Description

The sales rep reported that pink plastic pledget (fixed ramp) broke off during deployment in the procedure.Pledget (fixed ramp) was found at tip of straw (outer sheath) near plastic targeting block.

• Brand Name: HYDROMARK BREAST BIOPSY SITE MARKER
• 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): MICRO STAMPING CORPORATION; 12955 starkey rd.; suite 3700; largo FL 33773
• Manufacturer Contact: shawna rose ; 300 e-business way; fifth floor; cincinnati, OH 45241 ; 5138649178
• MDR Report Key: 6608892
• MDR Text Key: 76627993
• Report Number: 3008492462-2017-00036
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130537
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 4010-01-08-T4
• Device Catalogue Number: 4010-01-08-T4
• Device Lot Number: 200037113
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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