MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR MRI BIOPSY PROBE; BIOSPY INSTRUMENT

Catalog Number	ECPMR0110G
Medical Device Problem Codes	Break (1069); Crack (1135); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/08/2017
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 is currently under way.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 post breast biopsy under mri guidance, the probe trocar tip was allegedly detached from the probe once removed from patient.It was further reported the tip was not visible in the patient under imaging or in the device packaging.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a complete manufacturing review could not be conducted as the investigation is lot number unknown.Investigation summary: one encor probe was returned for evaluation.The returned probe was received with the trocar tip detached.The trocar tip was not returned for evaluation.The returned probe was also received with the cutter rotated within the cannula, indicating broken internal stops, and a crack was noted to the base of the returned probe.The internal stops were examined and identified to be broken.Therefore, the investigation is confirmed for the reported detachment, as well as confirmed for the identified break and crack.Per the evaluation results, the distal end of the cannula was noted to be crimped and there were no indications of laser welding along the rim of the cannula.The manufacturing site (infus) investigated the findings and determined that the crimp marks on the returned product were not due to the manufacturing process at infus as they have no equipment or process to make such marks.All trocar tips are 100% laser welded.Additionally, the product was transferred from senorx ((b)(4)) to infus ((b)(4)) in 2010.Prior to the transfer, it is known that senorx manufacturing process was to crimp the trocar tips to the probe cannula.Based on the available information, it was determined the returned probe is not from the reported lot.Furthermore, the identified broken internal stops contributed to the identified crack in the base of the probe, rotated cutter, and detached trocar tip.The broken internal stops allowed the cutter to advance too far forward and over-rotate.Likewise, the broken internal stops forced the cutter into the probe tip.The definitive root cause for the identified broken internal stops could not be determined.Labeling review: the current instructions for use (ifu) states: the bard encor breast biopsy device (probe) is indicated for use in acquiring tissue for diagnosing breast abnormalities.The encor breast biopsy probe contains a sharp trocar tip at the distal end for insertion and oscillating tubular cutter for tissue acquisition.Warnings: care must be taken when positioning the device trocar tip near the chest wall or skin margin.This device has been designed for single use only.Reusing this medical device bears the risk of cross-patient contamination as medical devices are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time.Precautions: a scalpel should be used to incise the skin prior to inserting the trocar tip.The encor probe is provided sterile and is intended for single use only.Do not resterilize.Complications: complications that may be associated with the use of the encor biopsy device and driver are the same as those associated with the use of other biopsy devices.These may include injury to the skin, blood vessels, muscles, organs, bleeding, hematoma and infection.
Event or Problem Description
It was reported that post breast biopsy under mri guidance, the probe trocar tip was allegedly detached from the probe once removed from patient.It was further reported the tip was not visible in the patient under imaging or in the device packaging.There was no reported patient injury.

• Brand Name: ENCOR MRI BIOPSY PROBE
• Common Device Name: BIOSPY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6933264
• Report Number: 2020394-2017-01310
• Device Sequence Number: 1181771
• Product Code: KNW
• UDI-Device Identifier: 00801741086304
• UDI-Public: (01)00801741086304
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K040842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 02/14/2018

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 Expiration Date: 03/01/2019
• Device Catalogue Number: ECPMR0110G
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2017
• Initial Date Received by Manufacturer: 09/12/2017
• Supplement Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 10/09/2017
• Supplement Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 28 YR