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

Catalog Number	121616
Medical Device Problem Codes	Self-Activation or Keying (1557); Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device was returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Expiration date: (01/2021).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 renal procedure the biopsy instrument allegedly did not obtain any tissue sample.Reportedly, another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
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.One monopty biopsy needle was returned for evaluation.A visual inspection was performed.The device was returned with the arrow visible in the ready window, indicating the device was in the "ready to fire state".The stylet was noted to be retracted as expected.However, the cannula was not retracted as it was noted to be extending over and covering the stylet.The return condition indicates that the cannula released on its own.Therefore, the investigation is confirmed for cannula self activation.Further inspection of the device noted incidental damage to the cannula tip.Therefore, functional evaluation could not be performed and the investigation is inconclusive for failure to obtain sample.Per evaluation results, the device was returned fully primed in the "ready to fire state" with the cannula in a released configuration.While a definitive root cause could not be determined based upon available information, it is possible that shipping and/or handling issues contributed to the identified self activation issue.However, it is unknown if patient and/or procedural issues contributed to the reported sampling issue.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.(b)(4).
Event or Problem Description
It was reported that during a renal procedure the biopsy instrument allegedly did not obtain any tissue sample.Reportedly, another device was used to complete the procedure.There was no reported patient injury.

• Brand Name: MONOPTY BIOPSY INSTRUMENT
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 7930640
• Report Number: 2020394-2018-01843
• Device Sequence Number: 1346856
• Product Code: KNW
• UDI-Device Identifier: 00801741084614
• UDI-Public: (01)00801741084614
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K133948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 11/14/2018

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 Catalogue Number: 121616
• Device Lot Number: RECN3067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Initial Date Received by Manufacturer: 09/06/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 10/03/2018
• Supplement Report FDA Received Date: 11/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 5 YR
• Patient Weight: 26