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

Catalog Number	1610MS
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	05/07/2025
Type of Reportable Event	Malfunction
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 device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.Section a through f ¿ the information provided 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 for an ultrasound guided axillary biopsy through normal density tissue using mission.During the procedure, the device allegedly failed to advance.It was further reported that patient experiencing hematoma.No coaxial was used and the current status of the patient is unknown.
Additional Manufacturer Narrative
H11: additional information was received, and the file was reassessed for reportability and determined to be reportable as malfunction.Manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one mission disposable core biopsy device was received for evaluation.During visual evaluation, the device appeared to have blood residue throughout and was returned in primed configuration with the cannula at the 20 mm position and the sample notch was exposed.Upon microscopic evaluation, the distal tip of the stylet did not appear to be dull.Due to the nature of the complaint, no functional testing was performed.Therefore, the investigation is inconclusive for the reported difficult to insert as the condition of use cannot be replicated due to the absence of appropriate laboratory setup.A definitive root cause for the alleged difficult to insert 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.B5, d4 (unique identifier (udi) #), g3, h1, h6 (patient, 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 for an ultrasound guided axillary biopsy through normal density tissue using mission.During the procedure, the device allegedly failed to advance.It was further reported that patient experienced a hematoma.No coaxial was used.There was no reported patient injury.

• Brand Name: MISSION
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 22504092
• Report Number: 2020394-2025-01024
• Device Sequence Number: 8788779
• Product Code: KNW
• UDI-Device Identifier: 00801741096969
• UDI-Public: (01)00801741096969(11)241229(17)271128(10)0001600036
• Combination Product (Y/N): N
• Initial Reporter Country: JO
• PMA/510(K) Number: K171953
• 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): 08/25/2025

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: 1610MS
• Device Lot Number: 0001600036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 07/15/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/29/2024
• 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: Female