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

Catalog Number	121410
Medical Device Problem Codes	Failure to Prime (1492); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or no medical images have been made available to the manufacturer.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.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 stereotactic guided breast biopsy, after six sample passes, the device allegedly was unable to prime at first.However, once device was primed and fired, the inner stylet detached from the outer cannula.Reportedly, the procedure was completed with another device.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a lot history review was conducted and it was determined that a device history record (dhr) review was not required.Investigation summary: one monopty biopsy needle was returned.The investigation is confirmed for detachment of device or device component, as the needle was detached from the stylet hub upon inspection.No other anomalies were noted with stylet needle.However, the investigation is inconclusive for failure to prime as a functional evaluation could not be conducted due to the condition of the return sample.Per the reported event details, six samples were taken before the reported priming issue was observed and the target lesion was noted to be calcified.While a definitive root cause could not be determined based upon available information, patient factor may have contributed to the reported event.Additionally, it was reported that priming issues were experienced before a final attempt to fully prime the device, followed by the subsequently identification of the detached stylet needle.It is unknown if procedural issues also contributed to the reported event.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
Event or Problem Description
It was reported that during a stereotactic guided breast biopsy, after six sample passes, the device allegedly was unable to prime at first.However, once device was primed and fired, the inner stylet detached from the outer cannula.Reportedly, the procedure was completed with another device.There was no reported patient injury.

• Brand Name: BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7378052
• Report Number: 2020394-2018-00298
• Device Sequence Number: 19175746
• Product Code: KNW
• UDI-Device Identifier: 00801741084584
• UDI-Public: (01)00801741084584
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K133948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2018

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 Expiration Date: 08/31/2020
• Device Catalogue Number: 121410
• Device Lot Number: REBV2501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2018
• Initial Date Received by Manufacturer: 03/01/2018
• Supplement Date Received by Manufacturer: 06/06/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 06/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR