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

Catalog Number	121610
Medical Device Problem Codes	Difficult to Remove (1528); Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or 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.Expiry date: 06/2021.
Event or Problem Description
It was reported that during a biopsy procedure, after the first sample pass, the device allegedly failed to obtain a tissue sample.It was further reported that the tissue was allegedly caught between the stylet and cannula, making it difficult to remove from the patient.There was no reported patient injury.
Additional Manufacturer Narrative
Investigation summary: one monopty needle was returned for evaluation.The device was able to prime, fire, and obtain samples without issue; therefore, the investigation is unconfirmed for failure to obtain samples.Although there were no issues removing the needle during functional testing, the conditions of use could not be recreated; therefore, the investigation for difficult to remove the needle from the patient is inconclusive.The definitive root cause could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the reported event.Labeling review:a review of the product instructions for use (ifu) procedural instructions, 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 biopsy procedure, after the first sample pass, the device allegedly failed to obtain a tissue sample.It was further reported that the tissue was allegedly caught between the stylet and cannula, making it difficult to remove from the patient.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: 7980930
• Report Number: 2020394-2018-01918
• Device Sequence Number: 19170678
• Product Code: KNW
• UDI-Device Identifier: 00801741084607
• UDI-Public: (01)00801741084607
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/07/2019

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 Catalogue Number: 121610
• Device Lot Number: RECT0592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2018
• Initial Date Received by Manufacturer: 09/25/2018
• Supplement Date Received by Manufacturer: 12/15/2018
• Initial Report FDA Received Date: 10/18/2018
• Supplement Report FDA Received Date: 01/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1