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

Model Number C1535J

Device Problem Material Fragmentation (1261)

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

Event Date 02/27/2017

Event Type  malfunction  

Manufacturer Narrative

The c1535 marker is a biopsy site identifier used to provide an imageable 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 history records were reviewed and there were no non-conformances that would relate to this failure.One c1535 was received on 4/4/2017 and investigated on 5/2/2017.The device was received in fair condition.Approximately 2cm of the flexible applicator shaft is missing.Communication with the customer confirmed that no parts of the c1535 applicator were transferred to the patient - no patient consequence.However, this event has been determined to be a reportable malfunction, pursuant to 21 cfr §803, because this malfunction has the potential to cause or contribute to a serious injury should pieces be transferred to the patient, requiring subsequent treatment.Thus, we are submitting this medwatch report.

Event Description

The (b)(6) affiliate reported that after sampling tissues, the doctor deployed the clip successfully.When the doctor pulled the c1535, the tip of the flexible introducer was broken and put into hh11bex probe.

• 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
• MDR Report Key: 6566136
• MDR Text Key: 75181484
• Report Number: 3008492462-2017-00030
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/10/2019
• Device Model Number: C1535J
• Device Catalogue Number: C1535
• Device Lot Number: F11411529D1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2014
• 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