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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR BIOPSY PROBE; BIOPSY INSTRUMENT
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BARD PERIPHERAL VASCULAR, INC. ENCOR BIOPSY PROBE; BIOPSY INSTRUMENT Back to Search Results
Model Number ECP017G
Device Problems Filling Problem (1233); Loose or Intermittent Connection (1371); Suction Problem (2170)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/04/2019
Event Type  malfunction  
Manufacturer Narrative
This event is being reported as a reportable malfunction for the special cause related to these product catalog/lot number combinations which is the subject of report of corrections and removal letter (806 notification) on may 2, 2019.(b)(4), expiry date 07/2020, manufacturing date 07/31/2018.As the lot number for the device was provided, a manufacturing review 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.
 
Event Description
It was reported that during a breast biopsy with ultrasound guidance, the system allegedly reported "insufficient vacuum" after several normal samples.It was further alleged that during device inspection, the sample tray was to found to be out of place and could not be inserted well.This issue persisted with the second sample tray.The procedure was completed with a new probe.There was no reported patient injury.
 
Event Description
It was reported that during a breast biopsy with ultrasound guidance, the system allegedly reported "insufficient vacuum" after several normal samples.It was further alleged that during device inspection, the sample tray was to found to be out of place and could not be inserted well.This issue persisted with the second sample tray.The procedure was completed with a new probe.There was no reported patient injury.
 
Manufacturer Narrative
A customer notification was issued for the encor breast biopsy probe for specific product code/lot number combinations.The affected product code/lot number combinations may be at risk of experiencing a leak between the probe and the tissue collection chamber, which could result in minimal suction, leakage, minimal or no tissue sample obtained, or an egress of fluids from the device.A root cause investigation and field action determination was conducted as a result of an increase in complaints for leaks, suction issues, and failure to obtain samples.The investigation included an extensive manufacturing review, risk documentation review for the three reported malfunctions, and evaluations performed on the returned devices.The investigation identified that one of the features on the trap chamber was under specified and during the implementation of a new trap chamber (dc2448) mold, one of the dimensions changed and went undetected, creating a difference between the amount of space that the seal has between the trap chamber and the front seal cap.This gap between the trap chamber and front seal cap resulted in conditions that led to a higher likelihood of leaks, suction issues, and failure to obtain samples.All reported complaints from the affected product code/lot number combinations that are possibly related to the gap between the trap chamber and front seal cap have been classified as leak, suction issues), or failure to obtain samples.This reported complaint is from an affected lot number that was reported for one of these trap chamber issues.One encor probe was returned for evaluation.The proximal retaining cap was glued to the probe.No visual anomalies were noted to the returned probe.The returned probe was functionally tested.The returned probe was able to obtain six samples successfully however, three of the six samples was acquired using additional vacuum to transport the sample to the sample chamber.Therefore, the investigation is confirmed for the identified filling problem as not all samples were able to successfully transport to the sample chamber as expected during functional testing.The investigation is also confirmed for the suction and seal issues as the reported lot is from an affected lot number reported for trap chamber issues.Additionally, the investigation is unconfirmed for the reported loose or intermittent connection issues as the device was able to obtain all samples during functional testing and no issues were identified.Although it is likely the confirmed gap between the trap chamber and front seal cap likely contributed to the identified filling problem, the definitive root cause for the identified filling problem and reported suction issue and loose or intermittent connection issue could not be determined based upon the provided information.It is unknown whether patient and/or procedural issues contributed to the reported event.(expiration date: 07/2020).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.
 
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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 Key8652343
MDR Text Key149367891
Report Number2020394-2019-00718
Device Sequence Number1
Product Code KNW
UDI-Device Identifier00801741086281
UDI-Public(01)00801741086281
Combination Product (y/n)N
PMA/PMN Number
K051158
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Notification
Type of Report Initial,Followup
Report Date 03/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/29/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberECP017G
Device Catalogue NumberECP017G
Device Lot NumberVTCU0343
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2019
Date Manufacturer Received03/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberZ-2211-2019
Patient Sequence Number1
Patient Age33 YR
Patient Weight56
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