MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR FOOT PEDAL; REUSABLE BIOPSY

Model Number FSENCOR01

Device Problems Failure to Read Input Signal (1581); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/04/2022

Event Type  malfunction  

Manufacturer Narrative

As the serial number for the device was provided, a review of the device history records will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiration date: 08/2045).

Event Description

It was reported that during a breast biopsy procedure, the device allegedly took samples from the wrong quadrant.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: a device history record and manufacturing review was not required as the event was determined to be expected and the investigation did not identify any manufacturing and/or service-related issues.Investigation summary: the encor fire forward device was received at the bd-bard global service & repair.The encor fire forward was visually inspected upon receipt and was found to be in good overall condition and functions normally.Further, found that the silver serial number label has a gouge in it exposing the painted metal underneath, there are paint chips on the edges and along the bottom exposing bare metal, and the serial number label upgrade need to be performed.The device was functionally tested while manipulating the cord and passed the test as all three switches responded normally and this was tested ten times with each switch.No other anomalies were identified.Therefore, the investigation is determined to be unconfirmed for the reported device is taking samples from the wrong quadrant and the device is not responding.The root cause for the reported device is taking samples from the wrong quadrant cannot be determined as the problem could not be reproduced.The root cause for the reported device is not responding also cannot be determined as the problem could not be reproduced.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: b5, d4 (expiration date: 08/2045), g3, h6 (device).H11: section a through f - the information provided by bd 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 bd.

Event Description

It was reported that during a breast biopsy procedure, the device allegedly took samples from the wrong quadrant.Further it was reported that the device was not responding intermittently.There was no reported patient injury.

• Brand Name: ENCOR FOOT PEDAL
• Type of Device: REUSABLE BIOPSY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): DYMAX CORP. -2523003; 110 marshall drive; warrendale PA 15086
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 15291369
• MDR Text Key: 302578647
• Report Number: 2020394-2022-00682
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741086557
• UDI-Public: (01)00801741086557
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K013641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FSENCOR01
• Device Catalogue Number: FSENCOR01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1