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

Catalog Number	MG1522
Medical Device Problem Codes	Failure to Fire (2610); Missing Information (4053)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2026
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 not been returned to the manufacturer for evaluation.However, a video was provided for review.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.
Event or Problem Description
It was reported that the magnum driver is not firing during the procedure.Additional clarification was provided stating the magnum driver primes successfully but fails to fire, the trigger mechanism is non functional and appears to be jammed.There was patient involvement, no injury was reported.Additionally, on the video provided by the customer demonstrating the issue with this driver with no patient involvement, it was observed that the serial number etching is missing on the magnum driver.

• Brand Name: MAGNUM INSTRUMENT
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): LAVELLE MACHINE; 485 groton road; westford 01886
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 24976666
• Report Number: 2020394-2026-01012
• Device Sequence Number: 18770362
• Product Code: KNW
• UDI-Device Identifier: 00801741083945
• UDI-Public: (01)00801741083945(17)120801
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K934371
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/11/2026

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: 08/01/2012
• Device Catalogue Number: MG1522
• 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: 03/27/2026
• Supplement Date Received by Manufacturer: 05/11/2026
• Initial Report FDA Received Date: 04/24/2026
• Supplement Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown