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

Model Number	ECP0112G
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/10/2019
Type of Reportable Event	Malfunction
Additional 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 central investigation was conducted as a result of an increase in complaints for leaks, suction issues, and failure to obtain samples.The central 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.(b)(4) , (expiry date:07/2020).
Event or Problem Description
It was reported that during preparation for a breast biopsy procedure, allegedly air was heard leaking from the seal of the tube collection chamber.There was no reported patient contact.
Event or Problem Description
It was reported that during preparation for a breast biopsy procedure, allegedly air was heard leaking from the seal of the tube collection chamber.There was no reported patient contact.
Additional 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.(expiration date: 07/2020), (device component code: 432).

• 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: 9321868
• Report Number: 2020394-2019-04593
• Device Sequence Number: 13940866
• 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,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/24/2019

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: VTCU0353
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 12/18/2019
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 12/24/2019
• 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