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

Model Number ECP017G

Device Problems Suction Problem (2170); Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/10/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot 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.(expiry date: 08/2021 ).

Event Description

It was reported that during an ultrasound guided breast biopsy procedure through fibroadenoma tissue, the device allegedly had a suction issue.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

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 and vacuum assembly.The probe appeared clean with the aperture approximately 100% closed.The saline cap was returned.The protective tubing was removed from the needle with resistance.It was noted foreign material appeared on the tip of the aperture.Skiving was noted to the inside of the protective tubing.The sample device was examined further under the microscope and foreign material was found to be on the aperture of the probe.The proximal retaining cap was glued to the probe.No damage was noted to the rear housing.No other anomalies were identified.The probe was loaded into the in-house driver and calibrated successfully.The maximum vacuum and vacuum differential testing's were performed.Both the test results were the minimum specification requirement.Using the in-house saline bag, the probe was inserted into a piece of beef and around the clock sampling was performed.Each time, the probe underwent the following processes: aperture opened, sample cut and sample deposited into the sample tray.The probe was able to obtain 6 samples successfully.No error was displayed on the console during testing.No unusual noises were heard during the evaluation.Therefore, based on the findings the investigation is confirmed for identified foreign material issue as the foreign material was found to be on the aperture of the probe.However, the investigation is unconfirmed for the reported suction issue as the device was obtained samples without issues.A definitive root cause for the reported failure 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.H10: d4 (expiry date: 08/2021), g3 h11: b5, h6 (result, conclusion) 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.See h10.

Event Description

It was reported that prior to an ultrasound guided breast biopsy procedure through fibroadenoma tissue, the device allegedly had a suction issue.The procedure was completed using another device.There was no patient contact.

• 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: 11371665
• MDR Text Key: 233259983
• Report Number: 2020394-2021-00322
• 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: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• 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: VTDV0565
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2021
• Date Manufacturer Received: 04/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Weight: 50