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

Catalog Number MC1816

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2024

Event Type  malfunction  

Event Description

It was reported that during an ultrasound guided lung biopsy procedure through normal tissue density, the outer casing was allegedly detached.No coaxial was used and the procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

H10: 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 photo was provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 02/2026).H11: 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.H3 other text : device not returned.

• Brand Name: MAXCORE
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 19103540
• MDR Text Key: 340910560
• Report Number: 2020394-2024-00511
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741084478
• UDI-Public: (01)00801741084478
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K133948
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MC1816
• Device Lot Number: REHQ0485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1