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

Catalog Number	121410
Medical Device Problem Codes	Difficult to Remove (1528); Self-Activation or Keying (1557); Failure to Obtain Sample (2533)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/11/2017
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 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 during an ultrasound-guided breast biopsy in normal density tissue, the device allegedly was unable to obtain tissue samples, and in order to remove the device from the breast, the cannula had to be retracted.It was further reported that the procedure was completed with another device and no coaxial was used.There was no reported patient injury.
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.Investigation summary: one monopty biopsy needle was returned for evaluation.Based on the returned condition of the device, the investigation is confirmed for self-activation.The sample was returned with the arrow visible in the ready window, thus indicating the device was in the "ready to fire state".Although the device was in the "ready to fire state", the cannula was noted to be covering the sample notch indicating the cannula had released.The device was further functionally tested and was able to prime, fire, and obtain samples without issue.Therefore, the investigation is unconfirmed for failure to obtain sample.However, the investigation is inconclusive for difficult to remove as the conditions of the procedure and patient tissue could not be replicated.It is possible that shipping and/or handling issues contributed to the identified self activation issue.However, a definitive root cause could not be determined as the issue could not be replicated.Additionally, the definitive root cause for the original reported event could not be determined based upon the available information.It is unknown if patient and/or procedural issues contributed to the sampling and needle removal issue.Labeling review: the current ifu (instructions for use) states: precautions: never test the product by firing into the air.Damage may occur to the needle/cannula tip and/or patient/user injury.Before using, inspect the needle for damaged point, bent shaft or other imperfections that would prevent proper function.If the needle components are damaged or bent, do not use.Unusual force applied to the stylet or unusual resistance against the stylet while extended out of the supportive cannula may cause the stylet to bend at the specimen notch.A bent specimen notch may interfere with the needle function.Directions for use: before using, inspect the needle for a damaged point, bent shaft or other imperfections that would prevent proper function.If the needle is damaged or bent, do not use.Prepare the monopty instrument for biopsy by twisting the rotational mechanism at the end of the instrument.One-half turn will withdraw the cannula and lock it into place.An additional one-half turn will withdraw the stylet and lock it into place.The instrument is ready to fire.The arrow must be visible in the ready window prior to insertion into the patient.Recommendation: for ease of insertion, puncture the skin with a scalpel at the entry site.Biopsy procedure: verify instrument is energized (cocked).Insert the tip of the needle prior to the lesion to be biopsied.While maintaining the instrument¿s position and the needle orientation, depress the actuator button to cause both the stylet and the cannula to automatically advance.Remove needle from patient and rotate the end of the instrument one-half turn to withdraw the cannula and expose the biopsy specimen.Remove the specimen.Potential complications: potential complications associated with core biopsy procedures are site specific and include, but are not limited to: hematoma; hemorrhage; infection; adjacent tissue injury; pain; bleeding; hemoptysis; hemothorax; non-target tissue, organ or vessel perforation; pneumothorax; and air embolism.Air embolism is a rare but serious potential complication of lung biopsy procedures.Rapid deterioration of neurological status and/or cardiac arrhythmia may be indicative of air embolism.Prompt diagnosis and treatment must be considered if the patient exhibits signs or symptoms of air embolism.
Event or Problem Description
It was reported that during an ultrasound-guided breast biopsy in normal density tissue, the device allegedly was unable to obtain tissue samples, and in order to remove the device from the breast, the cannula had to be retracted.It was further reported that the procedure was completed with another device and no coaxial was used.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: 7181148
• Report Number: 2020394-2017-01909
• Device Sequence Number: 19135567
• Product Code: KNW
• UDI-Device Identifier: 00801741084584
• UDI-Public: (01)00801741084584
• 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,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2018

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: 06/28/2018
• Device Catalogue Number: 121410
• Device Lot Number: REZF2019
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Initial Date Received by Manufacturer: 12/14/2017
• Supplement Date Received by Manufacturer: 02/23/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 03/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR