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

Model Number C1535

Device Problem Material Fragmentation (1261)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/20/2017

Event Type  malfunction  

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.The treating physician indicated no fragments of the device remained in the patient.However, as the occurrence has the potential to result in patient consequence with the need for surgical intervention or other form of treatment, should fragments have been transferred to the patient and pursuant to 21 cfr 803, we are submitting this medwatch report.

Event Description

The affiliate reported that the c1535 was not inserted smoothly into the probe, the doctor pulled the c1535 and then the flexible introducer was broken.The doctor told us that it seems there is not break of introducer in patient body.

• Brand Name: MICROMARK BIOPSY SITE MARKER
• Type of Device: 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 DE MEXICO; sor juana ines de la cruz; #20152 4-b, parque industrial; tijuana, baja california 22440 ; MX 22440
• Manufacturer Contact: shawna rose ; 300 e-business way; fifth floor; cincinnati, OH 45241 ; 5138649178
• MDR Report Key: 7178041
• MDR Text Key: 96852647
• Report Number: 3008492462-2018-00005
• Device Sequence Number: 1
• Product Code: NEU
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K013413
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C1535
• Device Catalogue Number: C1535
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2017
• 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: Initial
• Patient Sequence Number: 1