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

Catalog Number	VA80104
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an angioplasty procedure using the vaccess pta balloon.During the removal, the balloon allegedly broke apart.There was no reported patient injury.
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.D2b: (dqy; lit).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
A patient underwent an angioplasty procedure using the vaccess pta balloon.It was reported that during removal, the balloon allegedly broke apart.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one vaccess pta dilatation catheter returned for evaluation.Upon visual inspection, it was noted the distal end of the balloon was missing and not returned.It appeared to be a compound rupture on the proximal end of the balloon exposing the inner gw lumen.Marker bands were present.The luer and y-body was bloody.Due to the condition of the device such as compound rupture, no functional testing could be performed.Therefore, the investigation is confirmed for the reported detachment and identified compound rupture as compound rupture was noted to the balloon and distal end of the balloon was not returned.A definitive root cause for the reported detachment and identified compound rupture 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.D2b: (dqy; lit), g3, h6 (device, 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.

• Brand Name: VACCESS
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens 75751
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 22989764
• Report Number: 2020394-2025-01414
• Device Sequence Number: 9519076
• Product Code: LIT
• UDI-Device Identifier: 00801741121258
• UDI-Public: (01)00801741121258(17)280411(10)93RK0008
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K111850
• 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): 11/25/2025

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 Catalogue Number: VA80104
• Device Lot Number: 93RK0008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2025
• Supplement Date Received by Manufacturer: 11/12/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 11/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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