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

Model Number C1535

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/12/2019

Event Type  Injury  

Manufacturer Narrative

The c1535 micromark® ii tissue marker is indicated for use to attach to soft breast tissue at the surgical site during an open surgical breast biopsy or a percutaneous breast biopsy to radiographically mark the location of the biopsy procedure.The micromark ii tissue marker is a sterile, single patient use device comprised of a small stainless steel marker and a disposable introducer and applier.The introducer consists of a flexible tube, a distal ramp, and a lateral port.The applier consists of a flexible shaft, a deployment mechanism, and a handle.The marker is located at the distal end of the applier.The device has not been returned to the manufacturer for evaluation which prevents a full investigation and analysis of the root cause at this time.However, based on the instructions for use, the following could cause or contribute to reported event.Significant force to the applier handle when inserting device into probe for deployment.Removing the device independently from the probe when significant resistance is encountered.Twisting or kinking of the applier shaft.Based on the fact that there was an unintended piece of the markers' introducer left in the patient breast and pursuant to 21 cfr 803, we are submitting this medwatch report.

Event Description

Devicor medical products, inc.Received a report from our affiliate, devicor medical (b)(4), stating, the physician used 2 units of micromark.When micromark was inserted into the probe, it was resistant to insert.The physician pulled it back and it was found out that the introducer of micromark was broken, but not sheared.The clip was not released in 1st attempt.In the 2nd attempt, the clip was released successfully.It was resistant to pull back, and the introducer of micromark was sheared.After the procedure, the user obtained the u/s image and identified what seems to be a chip of the introducer.The patient requires surgical intervention.The clinician will remove the chip from patient's body during the surgical intervention.This has been documented in our system as record # (b)(4).

• Brand Name: MICROMARK BIOPSY SITE MARKER
• Type of Device: BIOPSY SITE MARKE
• 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,
• Manufacturer Contact: jill burnett ; 300 e. business way; fifth floor; cincinnati, OH 45241
• MDR Report Key: 8613918
• MDR Text Key: 145219571
• Report Number: 3008492462-2019-00021
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• PMA/PMN Number: K013413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: C1535
• Device Catalogue Number: C1535
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention