MAUDE Adverse Event Report: DEVICOR MEDICAL PRODUCTS, INC. MICROMARK BIOPSY SITE IDENTIFER; BIOPSY SITE IDENTIFIER

Model Number C1535

Device Problem Material Fragmentation (1261)

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

Event Date 03/01/2017

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.Device not yet returned to mfr.

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 flexible introducter was broken and put into aperture of mst11b probe.The broken tip may be not present in the body.

Manufacturer Narrative

One c1535 was received on april 4, 2017 and investigated on may 18, 2017.The marker deployment button, located on the handle, has been actuated indicating the marker has been deployed.Approximately 1 cm of the introducer shaft is missing.Returned with the c1535 was a mst11b probe that was used during biopsy procedure.The missing introducer shaft was found inside the probe.Based on the piece of the introducer shaft that was found in the probe cutter, along with the c1535, the entire introducer shaft was accounted for.A root cause cannot be determined.However, based on the instructions for use, the following could cause or contribute to a damaged device.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 date that new information was received.The initial reporter's corrected occupation.The new information was received by the manufacturer.This report is a follow-up report.This supplemental report is being submitted with additional information and device evaluation.The device was evaluated by the manufacturer.(b)(4).

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 flexible introducer was broken and put into aperture of mst11b probe.The broken tip may be not present in the body.

• Brand Name: MICROMARK BIOPSY SITE IDENTIFER
• 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): 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: 6459228
• MDR Text Key: 71837076
• Report Number: 3008492462-2017-00020
• 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,Followup
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: C1535
• Device Catalogue Number: C1535
• Device Lot Number: F11403301D1
• 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: 05/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2014
• 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