MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. BARD MARQUEE DISPOSABLE CORE BIOPSY INSTRUMENT KIT

Catalog Number	MQK1410
Medical Device Problem Codes	Failure to Prime (1492); Self-Activation or Keying (1557); Failure to Obtain Sample (2533); Failure to Fire (2610)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number of the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.( failure to fire).The information provided by bard 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 bard.
Event or Problem Description
It was reported that during a breast biopsy in dense tissue, after the first sample pass, the cannula allegedly was difficult to prime in order to retrieve the tissue sample and the tissue sample was of insufficient size.On the second sample pass, the device was fired using the semi-automatic trigger, but both cannula and stylet reportedly fired together.After the cannula was primed and the second tissue sample retrieved, the stylet allegedly was unable to prime.It was further reported that the procedure was completed with another device and a coaxial was used.There was no reported patient injury.
Event or Problem Description
It was reported that during a breast biopsy in dense tissue, after the first sample pass, the cannula allegedly was difficult to prime in order to retrieve the tissue sample and the tissue sample was of insufficient size.On the second sample pass, the device was fired using the semi-automatic trigger, but both cannula and stylet reportedly fired together.After the cannula was primed and the second tissue sample retrieved, the stylet allegedly was unable to prime.It was further reported that the procedure was completed with another device and a coaxial was used.There was no reported patient injury.
Additional Manufacturer Narrative
Upon review of the reported information, the device did not fire correctly but did not self-activate.The failure mode reported was incorrectly identified as self-activation.As a result the mdr decision tree and review of the mdr reportability guidelines (fm1292000 rev 4) were re-assessed.This event is no longer reportable on (b)(6) 2018; however, the mdr decision tree will continue to reflect a malfunction as an mdr has already been sent to the fda.

• Brand Name: BARD MARQUEE DISPOSABLE CORE BIOPSY INSTRUMENT KIT
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7589832
• Report Number: 2020394-2018-00843
• Device Sequence Number: 1946479
• Product Code: KNW
• UDI-Device Identifier: 00801741097287
• UDI-Public: (01)00801741097287
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K133948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2018

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 Catalogue Number: MQK1410
• Device Lot Number: HUCN1151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Initial Date Received by Manufacturer: 05/15/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 06/11/2018
• Supplement Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 64