MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VISILOC INTRODUCER SET; BIOPSY INSTRUMENT

Catalog Number	ECMRINTLOC
Medical Device Problem Codes	Break (1069); Device Contamination with Chemical or Other Material (2944); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2025, a patient underwent a biopsy procedure using the visiloc introducer set.Prior to the procedure, it was noted the contrast marker of the introducer set had black spots within the obstructor.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H10: 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.H11: 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 mri guided vacuum assisted biopsy through mass density, using the visiloc introducer set.Prior to the procedure, the needle of the device allegedly broke off.It was further reported that the half of the needle lodged in the visiloc and the other half remained in the patient.Reportedly, the broke fragments were removed using clips and confirmed no metal was left behind.There was no reported patient injury.
Additional Manufacturer Narrative
H11: additional information was received, and the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.B5, g2, g3, h6 (patient, device).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 an mri-guided vacuum assisted biopsy through mass density, using the visiloc introducer set.During the procedure, the needle of the device is allegedly broken off.It was further reported that half of the needle was lodged in the visiloc and the other half remained in the patient.Reportedly, the broken fragments were removed using the clips and confirmed no metal was left behind.There were no reported patient injuries.
Additional Manufacturer Narrative
H11: additional information was received, and the file was reassessed for reportability and determined to be reportable as a malfunction.Manufacturing review: the device history records (dhr) were reviewed and this lot met all release criteria.Investigation summary: one visiloc obturator was received with product label indicating product code ecmrintloc and lot# vtjx0515.During visual inspection, it was noted that the obturator was received in two segments.A break was noted at the handle and the fluid was no longer present.However, remanent of the fluid (e.G., black residue) was noted throughout the distal end of the obturator.Therefore, the investigation is confirmed for the identified break at the obturator handle.The definite root cause for the identified break at the obturator handle 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 (device, component, 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.

• Brand Name: VISILOC INTRODUCER SET
• 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: 22088922
• Report Number: 2020394-2025-00799
• Device Sequence Number: 20838860
• Product Code: KNW
• UDI-Device Identifier: 00801741086229
• UDI-Public: (01)00801741086229(11)241023(17)250401(10)VTJX0515
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K161805
• 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,Followup
• Report Date (Section B): 12/05/2025

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: 04/01/2025
• Device Catalogue Number: ECMRINTLOC
• Device Lot Number: VTJX0515
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: 08/26/2025; 12/04/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 09/09/2025; 12/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2024
• 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
• Patient Sex: Unknown