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 02/28/2017

Event Type  malfunction  

Manufacturer Narrative

The c1535 marker is a biopsy site identifier used to provide an imagable locator of a biopsy site for follow-up care.The marker is a stainless steel clip, contained within a disposable plastic applicator, which is deployed into the breast biopsy site through the biopsy probe that was used to excise the tissue.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, one possible root cause is the continuation of the insertion beyond significant resistance as described in the ifu.It is unconfirmed at this time whether any pieces of the c1535 applicator were transferred to 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, pursuant to 21 cfr 803, we are submitting this medwatch report.

Event Description

The (b)(4) affiliate reported that after sampling tissues, the doctor deployed the clip successfully.When the doctor pulled the c1535, the tip of the introducer was broken and put into aperture of mst11b probe.No patient complications.

• 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: 6546975
• MDR Text Key: 74488837
• Report Number: 3008492462-2017-00031
• 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: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2017
• 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?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2017
• 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