MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR FIRE FORWARD; BIOSPY EQUIPMENT

Catalog Number ENCFF02

Device Problems Bent (1059); Self-Activation or Keying (1557)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No medical records or medical images have been made available to the manufacturer.As the serial number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event 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 prior to use on patient, the device was firing forward without the healthcare provider pressing the fire button.There was no reported patient contact.

Manufacturer Narrative

Manufacturing review:a manufacturing review was conducted and the reported lot met all release criteria.Visual inspection:upon receipt, the fire forward was received with no visual discrepancies to the exterior of the device.Functional/performance evaluation: the device was functionally tested.The slide lock function was verified to have no issue by pressing the safety slides between the locked and unlocked positions freely; the safety slide repositioned to the center when released.The pierce button was able to be pressed in and released without issue.The driver release latch was able to be released without issue, and the driver bracket was able to engage and disengage from the fire froward without issue.The cocking handle was able to be rotated freely in both directions, and returned to the center position without issue.However, the devices failed a latching test.The device cover was removed and it was found that the internal slide plate was bent upwards, which did not allow the slide plate to adequately latch to the firing latch.Servicing: the slide plate and cover were replaced and the fire forward 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 investigation is confirmed for the reported self-activation, due to a bent internal slide plate.The damaged internal slide plate allowed device to fire prematurely.However, the definitive root cause for the damaged component could not be determined based upon available information.Labeling review: the current instructions for use states: warnings: the device should only be used by physicians trained in percutaneous biopsy procedures; care must be taken to set-up fire forward per biopsy table instructions to avoid chest wall injury; exercise care when handling the fire forward while armed; verify secure attachment of the encor driver to the fire forward mounting pins and screw avoid misalignment of the probe tip or detachment of the driver.Complications: complications that may be associated with the use of the fire forward are the same as those associated with common types of spring powered notched biopsy needle devices.Directions for use - fire forward operation: arm the fire forward mechanism by rotating the handle in either direction to its stop and armed position.The handle will return automatically to its center position; insert the encor probe tip into and through the needle guide and slide the driver bracket onto the fire forward until it locks into place.Verify that the driver bracket has latched and is securely attached to the fire forward accessory.If desired, the cord deflectors can be flipped outward from the bottom of the fire forward accessory to route the driver cord and disposable tubing out of the way.Verify that the disposable tubing is not kinked during use; while pressing and holding either safety switch from either side of the fire forward, press the pierce button to advance the probe tip into the targeted lesion.(b)(4).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 prior to use on patient, the device was firing forward without the healthcare provider pressing the fire button.There was no reported patient contact.

• Brand Name: ENCOR FIRE FORWARD
• Type of Device: BIOSPY EQUIPMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): DYMAX CORP.; 110 marshall drive; warrendale PA 15086
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 6000202
• MDR Text Key: 56483358
• Report Number: 2020394-2016-00923
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741086458
• UDI-Public: (01)00801741086458
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ENCFF02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/01/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2014
• 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