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

Catalog Number	121610
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As a result of a retrospective review of events that occurred in (b)(6) and in accordance with 21 c.F.R.Part 803, this event was assessed and determined to be mdr reportable.No medical records or no medical images have been made available to the manufacturer; however a photo was provided.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation to date.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 breast biopsy, the health care provider allegedly had difficulty removing the biopsy needle from the patient.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a complete manufacturing review could not be conducted for the investigation as the lot number was unknown.Visual/microscopic inspection: as the device was not returned, an inspection could not be performed.Functional/performance evaluation: as the device was not returned, an evaluation could not be performed.Medical records review as medical records were not provided, a review could not be performed.Image/photo review: one electronic photo was received and reviewed.The photo shows an entire monopty biopsy needle lying over a surface covered with brown paper towels.The needle appears to be clean.The stylet and cannula appear to be in their initial positions as the sample notch is not exposed.The ready window is not visible in the photo.No anomalies are noted on the needle.Based on the photo review, difficult to remove cannot be confirmed.Conclusion: although the sample was not returned for evaluation, one electronic photo was provided for review.The investigation is inconclusive for difficult to remove, as the photo review could not confirm a device-tissue interaction issue and no anomalies were noted on the needle.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: 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 a breast biopsy, the health care provider allegedly had difficulty removing the biopsy needle from the patient.There was no reported patient injury.

• Brand Name: MONOPTY
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6767324
• Report Number: 2020394-2017-00913
• Device Sequence Number: 11254596
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2017

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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/18/2016
• Supplement Date Received by Manufacturer: 08/18/2017
• Initial Report FDA Received Date: 08/04/2017
• Supplement Report FDA Received Date: 08/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1