MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ELEVATION PROBE; DISPOSABLE BIOPSY

Catalog Number	EV10
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.H11:section a through f - the information provided by bd 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 bd.
Event or Problem Description
It was reported that during an ultrasound guided biopsy procedure, the connection of the support cannula was allegedly dislodged.The procedure was completed using the same device.There was no reported patient injury.
Event or Problem Description
It was reported that during an ultrasound guided biopsy procedure, the connection of the support cannula was allegedly dislodged.The procedure was completed using the same device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: one elevation biopsy probe was received for evaluation.During visual evaluation, the probe appeared to have blood residue throughout the cannula, on the outer housing, and in the sample tank base, the sample tank base was secured to the probe cover insert, the sample tank basket was not returned, the main probe assembly was pushed forward on the probe cover insert, both the cutting and transport spindles were in initial position, the support cannula appeared to be detached from the cannula grasp and also the support cannula was returned.Furthermore, the cannula was inspected, and the adhesive was noted to be non-homogeneous at the proximal end of the support cannula where it connects to the probe body.Due to the condition of the sample and the nature of the complaint, functional testing was not performed.Therefore the investigation is confirmed for the reported detachment of components as the support cannula was observed to be detached from the cannula grasp.A definitive root cause for the alleged detachment 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.H11:section a through f - the information provided by bd 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 bd.

• Brand Name: ELEVATION PROBE
• Common Device Name: DISPOSABLE BIOPSY
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FERROSAN MEDICAL DEVICES SP. Z.O.O.; ul. koksowa 3; 70-031 szczecin ; PL
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19708632
• Report Number: 2020394-2024-01009
• Device Sequence Number: 11566150
• Product Code: KNW
• UDI-Device Identifier: 00801741182372
• UDI-Public: (01)00801741182372
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K192948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2024

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: EV10
• Device Lot Number: UNKNOWN
• 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: 06/14/2024
• Supplement Date Received by Manufacturer: 12/05/2024
• Initial Report FDA Received Date: 07/10/2024
• Supplement Report FDA Received Date: 12/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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