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

Model Number C1535

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2017

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.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.Device not yet received for analysis.

Event Description

The affiliate reported that after sampling tissues, the doctor deployed the clip successfully.When the doctor pulled the c1535, the tip of flexible introducer was broken and put into aperture of mst11b probe.The doctor told us that excessive resistance is not encountered during removal.There were no patient complications.The procedure was completed with the device.

Manufacturer Narrative

One c1535 was received on february 28, 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 is 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.Updated to reflect the date that new information was received.Updated to include the lot# based on the device returned for investigation.Updated to include the expiration date of the device.Updated to list the operator of the device.Updated to reflect the initial reporter's corrected occupation.Updated to reflect the date the new information was received by the manufacturer.Updated to reflect that this report is a follow-up report.Updated to reflect that this supplemental report is being submitted with additional information and device evaluation.Updated to reflect that the device was evaluated by the manufacturer.Updated to reflect the device manufacture date.Was updated to check "initial use of device" (b)(4).

Event Description

The affiliate reported that after sampling tissues, the doctor deployed the clip successfully.When the doctor pulled the c1535, the tip of flexible introducer was broken and put into aperture of mst11b probe.The doctor told us that excessive resistance is not encountered during removal.There were no patient complications.The procedure was completed with the device.

• Brand Name: MICROMARK
• 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: 6338703
• MDR Text Key: 67657166
• Report Number: 3008492462-2017-00003
• 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: 02/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/05/2020
• Device Model Number: C1535
• Device Catalogue Number: C1535
• Device Lot Number: F11541418D1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2015
• 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