MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR BIOPSY PROBE; BIOPSY INSTRUMENT

Catalog Number ECP0110GV

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

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

Event Date 11/09/2023

Event Type  malfunction  

Event Description

It was reported that during a biopsy procedure, the equipment allegedly failed and the error 1018 was restarted but still persisted.It was further reported that when the needle was removed, the cutting area of the needle in the metal area was allegedly found to be fragmented.There was no reported patient injury.

Manufacturer Narrative

H10: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for the encor product is adroit medical equipment.H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 12/2024).H11: section a through f ¿ the information provided by bd represents all 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.H3 other text : device not returned.

Manufacturer Narrative

H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for the encor product is adroit medical equipment.H10: b5, d4 (expiry date: 12/2024), g3.H11: section a through f ¿ the information provided by bd represents all 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.Device not returned.

Event Description

It was reported that during a stereotaxic guided biopsy procedure through normal density tissue, when starting the aspiration, the equipment allegedly crashed with error 1018 indication on the screen and the screen remained stuck even on pressing the reset button.It was further reported that when the needle was removed, the cutting area of the needle in the metal area was allegedly found to be fragmented.There was no reported patient injury.

• Brand Name: ENCOR BIOPSY PROBE
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): UNKNOWN; BR
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18281455
• MDR Text Key: 329890211
• Report Number: 2020394-2023-01156
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K040842
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ECP0110GV
• Device Lot Number: VTGZG002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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