MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR DRIVER; BIOPSY EQUIPMENT

Catalog Number DRENCOR

Device Problems Contamination (1120); Mechanical Problem (1384); Self-Activation or Keying (1557); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 11/10/2015

Event Type  malfunction  

Manufacturer Narrative

The serial number for the device has been provided.A review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.The investigation is currently underway.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that during a stereotactic breast biopsy, the device was connected to the mammography unit and the vacuum allegedly activated.The driver and probe were allegedly making a rattling noise.The driver allegedly was not selected to begin sampling and the sample notch opened.The procedure was canceled and the patient was rescheduled.

Manufacturer Narrative

A manufacturing review was conducted and the reported lot met all release criteria.Visual inspection: the sample was returned for evaluation.The driver was received with no visual discrepancies to the exterior of the device.However, upon further examination of the internal components, the driver was found to be contaminated with an unknown fluid.The front pcb switch was not working and the flexi circuit pcb was found to be corroded.Functional/performance evaluation: the driver failed to calibrate test probes due to the contamination and damaged internal components.A motor power and voltage test were unable to be performed due to the condition of the returned device.The damaged components were replaced and the driver passed all functional tests.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: images/photos were not provided; therefore, a review could not be performed.Conclusion: the driver was returned with no external visual discrepancies.An electrical test was performed, and the returned device failed.The device was able to power on, however the driver was unable to calibrate, to fully test the device.The internal components were examined and an unidentifiable residue was found in the interior of the driver.It is likely that the residue found in the driver, led to the reported issue.A definitive root cause for the unidentifiable residue within the driver could not be determined based upon available information.However, once the driver was serviced and cleaned, it was able to meet all functional requirements.Labeling review: current instructions for use: warnings: care must be taken when positioning the device trocar tip near the chest wall or skin margin.Complications: complications that may be associated with the use of the encor® biopsy device and driver are the same as those associated with the use of other biopsy devices.These may include injury to the skin, blood vessels, muscles, organs, bleeding, hematoma and infection.Directions for use: for handheld use: the ¿vac¿ (vacuum) button may be utilized to evacuate fluid or blood.Using the enabled sample rinse feature: depress the ¿vac¿ button/footswitch and press the ¿rinse sample¿ button on the control unit to rinse and evacuate the fluid from the tissue collection chamber.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

• Brand Name: ENCOR DRIVER
• Type of Device: BIOPSY EQUIPMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 west 3rd st.; tempe AZ 85281
• Manufacturer (Section G): DYMAX CORP.; 110 marshall drive; warrendale PA 15086
• Manufacturer Contact: judith ludwig ; 1625 west 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 5310396
• MDR Text Key: 34604562
• Report Number: 2020394-2015-02032
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K040842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DRENCOR
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2015
• Initial Date FDA Received: 12/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1