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

Catalog Number	ECPMR0110GBT
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an mri guided vacuum assisted breast biopsy through mass density, the needle of the device allegedly broke off.It was further reported that the half of the needle lodged in the visiloc and the other half remained in the patient.Reportedly the broke fragments were removed using clips and confirmed no metal was left behind.There was no reported patient injury.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.H11: section a through f: the information provide by bd represents all 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 bd.
Event or Problem Description
On (b)(6) 2024, a patient underwent a mri guided vacuum assisted breast biopsy through mass density, during the procedure it was reported that the needle of the device allegedly broke off.It was further reported that the half of the needle lodged in the visiloc and the other half remained in the patient.Reportedly the broke fragments were removed using clips and confirmed no metal was left behind.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records were reviewed and this lot met all release criteria.Investigation summary: one 10g encor mri blunt tip biopsy probe and removable probe cover were received for investigation.The sample trap assembly was not returned.Product packaging and labeling were returned for the probe and verified with tw.The probe was received without protective tubing and appeared clean upon receipt.The probe body was rotates to identify any cracks.No cracks were observed on the probe body.The probe gears appeared to be clean.Visual inspection identified that the sample trap assembly was not returned.No damage was observed on the rear housing.The probe body was rotated to inspect for cracks, and none were observed and the probe gears appeared clean.Dried blood and tissue were present within the cutter.The probe was noted to be missing its aperture, and markings were observed throughout the cutter.No additional anomalies were identified during the initial inspection.A further device review was conducted and determined that the cannula tip was detached from the cannula body.The detached cannula tip was not returned with the complaint sample.Apparent weld marks were noted on the returned cannula body.The weld marks appear continuous and acceptable.However, the cannula tip was not returned and therefore the entire welding area could not be thoroughly inspected.Due to the reported breakage and identified detached components, functional testing was not performed.Based on the returned sample evaluation, the investigation is unconfirmed for the reported break and identified for detachment of device or device component as the encor probe was received with the cannula tip detached from the cannula body.It was determined the root cause of the detachment was most likely caused by a welding defect from the cannula supplier.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.B5, d4 (unique identifier (udi) #), g2, g3, h6 (device, component, method, result, conclusion).Section a through f: the information provide by bd represents all 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 bd.

• Brand Name: ENCOR MRI BIOPSY PROBE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): INFUS MEDICAL (THAILAND); 706 moo 4; bangpoo ind estate; samutprakarn province 10280 ; TH 10280
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 20813619
• Report Number: 2020394-2024-01756
• Device Sequence Number: 18625503
• Product Code: KNW
• UDI-Device Identifier: 00801741086311
• UDI-Public: (01)00801741086311(11)240209(17)251201(10)VTHZ0667
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K233220
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2025

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: 12/01/2025
• Device Catalogue Number: ECPMR0110GBT
• Device Lot Number: VTHZ0667
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2024
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 11/30/2024
• Supplement Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown