MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR BIO PROBE 7G; BIOPSY INSTRUMENT

Catalog Number	ECP017G
Medical Device Problem Code	Failure to Obtain Sample (2533)
Health Effect - Clinical Codes	Hematoma (1884); Discomfort (2330)
Date of Event	07/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2025, a patient underwent a vacuum assisted breast biopsy procedure using an encor probe.During the procedure needle was taken out without collecting sample.Additionally, there was a residual hematoma, larger than expected which was resolved with conservative treatment.In which lead to procedure time taking longer than normal, causing more discomfort to the patient.The current status of the patient is unknown.
Additional Manufacturer Narrative
H11: 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.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.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the reported failure to obtain sample issue could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D4 (unique identifier (udi) #), g3, h6 (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.
Event or Problem Description
On (b)(6) 2025, a patient underwent a vacuum assisted breast biopsy procedure using an encor probe,.During the procedure needle was taken out without collecting sample.Additionally, there was a residual hematoma, larger than expected which was resolved with conservative treatment.In which lead to procedure time taking longer than normal, causing more discomfort to the patient.The current status of the patient is unknown.

• Brand Name: ENCOR BIO PROBE 7G
• 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: 22949796
• Report Number: 2020394-2025-01386
• Device Sequence Number: 9515154
• Product Code: KNW
• UDI-Device Identifier: 00801741086281
• UDI-Public: (01)00801741086281(11)241202(17)261028(10)VTJYA001
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K051158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ECP017G
• Device Lot Number: VTJYA001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 12/04/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/02/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown