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

Model Number	ECP0112G
Medical Device Problem Codes	Suction Problem (2170); Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/10/2019
Type of Reportable Event	Malfunction
Additional 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.As the lot number for the device was provided, a manufacturing review will be performed.The sample has been returned to the manufacturer for inspection/evaluation.The investigation of the reported event is currently underway.(b)(4), (expiry date 11/2020).
Event or Problem Description
It was reported that during a biopsy procedure, the device allegedly failed to obtain samples and had a suction issue.There was no reported patient injury.
Event or Problem Description
It was reported that during a biopsy procedure, the device allegedly failed to obtain samples and had a suction issue.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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.H10: d4 (expiration date: 11/2020), g4, h6 (device component code: 432).H11: 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.

• Brand Name: ENCOR BIOPSY PROBE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9187831
• Report Number: 2020394-2019-03906
• Device Sequence Number: 2811052
• Product Code: KNW
• UDI-Device Identifier: 00801741086267
• UDI-Public: (01)00801741086267
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ECP0112G
• Device Catalogue Number: ECP0112G
• Device Lot Number: VTCY0543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2211-2019
• Patient Sequence Number: 1