MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR (BPV) BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT

Catalog Number	121616
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Pain (1994)
Date of Event	03/09/2018
Type of Reportable Event	Serious Injury
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 return of the device is pending.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 prior to the ct-scan-guided liver biopsy into a normal density tissue, the device was inspected prior to use and was dry-fired outside of the patient.During the biopsy, the needle of the device allegedly got stuck in the liver and was allegedly difficult to remove from the tissue, therefore the needle was manually removed.No tissue samples were able to be obtained and no coaxial was used for this procedure.It was further reported that the patient experienced severe pain upon awakening and intra-vesicular bleeding was observed.The patient was further hospitalized and given analgesic treatment.Reportedly, the patient is being monitored for possible cholecystostomy.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.This is the only complaint reported to date for this lot number and failure mode.Investigation summary: one monopty biopsy needle was returned.Functional testing was performed.The device functioned properly under laboratory conditions and the reported event could not be reproduced.The device was able to prime, fire and obtain samples without issue.However, the specific conditions of the event, (i.E.Patient tissue) could not be replicated.Therefore, the investigation is inconclusive for difficult to remove.The definitive root cause could not be determined based upon available information.Per the reported event details, the device was dry fired prior to use.The instructions for use (ifu) states, "never test the product by firing into the air.Damage may occur to the needle/cannula tip." while a definitive root cause could not be determined, it is possible that 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.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 prior to the ct-scan-guided liver biopsy into a normal density tissue, the device was inspected prior to use and was dry-fired outside of the patient.During the biopsy, the needle of the device allegedly got stuck in the liver and was allegedly difficult to remove from the tissue, therefore the needle was manually removed.No tissue samples were able to be obtained and no coaxial was used for this procedure.It was further reported that the patient experienced severe pain upon awakening and intra-vesicular bleeding was observed.The patient was further hospitalized and given analgesic treatment.Reportedly, the patient is being monitored for possible cholecystostomy.

• Brand Name: BARD MONOPTY DISPOSABLE CORE BIOPSY INSTRUMENT
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR (BPV); KS
• MDR Report Key: 7404217
• Report Number: 2020394-2018-00349
• Device Sequence Number: 16160894
• Product Code: KNW
• UDI-Device Identifier: 00801741084614
• UDI-Public: (01)00801741084614
• Combination Product (Y/N): N
• PMA/510(K) Number: K133948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2020
• Device Catalogue Number: 121616
• Device Lot Number: REBV0452
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Initial Date Received by Manufacturer: 03/14/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 04/06/2018
• Supplement Report FDA Received Date: 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention