MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. VASCUTRAK; PTA BALLOON DILATATION CATHETER

Catalog Number	V1850100
Medical Device Problem Codes	Material Puncture/Hole (1504); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
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 device has been returned to the manufacturer for evaluation.However, photos and video were provided for review.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 prior to an angioplasty procedure, the guidewire was allegedly exposed on the outside of the pta balloon.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: the device was also returned for evaluation.An unknown wire was noted to be exiting from the device proximal guidewire port.The sample was returned to the manufacturing facility for additional evaluation where it was determined the wire was a mandrel used during the balloon coating process that was left in the device after the manufacturing step.The mandrel was not removed in the correct step and was not observed and removed during final manufacturing inspection.Three photos and one video provided for review.The three photos show a device with what looks to be an unknown wire protruding from a guidewire exit port.The provided video shows the clinician bending a catheter to show the unknown wire protruding from the device.Therefore, the investigation is unconfirmed for the reported puncture as the protruding wire was found to be a mandrel used during manufacturing and will be confirmed for the identified contamination.The root cause was determined to be manufacturing related and (b)(4) was initiated to the manufacturing facility due to the event.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.D.4.(unique identifier udi) #), g3, h6 (device, component, method, result, conclusion).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 prior to an angioplasty procedure, the guidewire was allegedly exposed on the outside of the pta balloon.The procedure was completed using another device.There was no patient contact.

• Brand Name: VASCUTRAK
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 21557339
• Report Number: 2020394-2025-00298
• Device Sequence Number: 18542064
• Product Code: PNO
• UDI-Device Identifier: 00801741061677
• UDI-Public: (01)00801741061677(11)220430(17)250328(10)GFGQ3164
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K103459
• 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): 09/10/2025

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: 03/28/2025
• Device Catalogue Number: V1850100
• Device Lot Number: GFGQ3164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Supplement Date Received by Manufacturer: 09/05/2025
• Initial Report FDA Received Date: 03/10/2025
• Supplement Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/30/2022
• 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