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

Model Number ECP017G

Device Problems Break (1069); Suction Problem (2170); Failure to Obtain Sample (2533); Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/11/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 08/2021).

Event Description

It was reported that during an ultrasound-guided breast biopsy procedure, through fibroadenoma tissue the device allegedly failed to obtain samples.It was further reported that negative pressure bucket was allegedly broken.The procedure was completed using open surgery.There was no reported patient injury.

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: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one encor biopsy probe was returned for evaluation.On the visual evaluation of the device, the probe was bloody with the aperture approximately 100% closed.The proximal retaining cap has glued to the probe, no other damage was noted on the rear housing.On the functional evaluation, the probe was loaded into the in-house driver and calibrated successfully.The probe meets the acceptance level for the vacuum differential test and fails to meet the acceptance level for the maximum vacuum test.Then, the probe was inserted into a piece of beef and around the clock, sampling was performed.The probe underwent aperture opened, sample cut, and sample deposited into the sample tray and obtained six beef samples without any issue.Therefore, the investigation is confirmed for identified suction as the probe fails to meet the requirement of maximum vacuum test.However, the reported failure to obtain samples is inconclusive as the suction issue may lead to the sampling problem.A definitive root cause could not be determined based upon the provided information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H11: section a through f ¿ the information provide 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.

Event Description

It was reported that during an ultrasound-guided breast biopsy procedure, through fibroadenoma tissue the device allegedly failed to obtain samples.The procedure was completed using open surgery.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
• MDR Report Key: 11271121
• MDR Text Key: 230040106
• Report Number: 2020394-2021-00114
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741086281
• UDI-Public: (01)00801741086281
• Combination Product (y/n): N
• PMA/PMN Number: K051158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ECP017G
• Device Catalogue Number: ECP017G
• Device Lot Number: VTDV0561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2020
• Date Manufacturer Received: 06/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other