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

Catalog Number	VA80124
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/26/2025
Type of Reportable Event	Serious 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 not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.D2b: (dqy; lit).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.
Event or Problem Description
On (b)(6) 2025, a patient underwent a percutaneous transluminal angioplasty (pta) procedure using the vaccess pta balloon catheter.During the procedure, it was reported that the balloon was inflated and then totally deflated.As the balloon was pulled back out of the stent, the balloon got caught on a stent strut.It was further reported that the balloon then broke in half and part of the tip remained in the vessel as they pulled the whole balloon out of the body.The patient then started to bleed profusely, and they had to apply a tourniquet.The patient was taken to the hospital where a vascular surgeon was able to take the broken off tip out of the vessel.The current status of the patient was unknown.
Event or Problem Description
On (b)(6) 2025, a patient underwent a percutaneous transluminal angioplasty (pta) procedure using the vaccess pta balloon catheter.During the procedure, it was reported that the balloon was inflated and then totally deflated.As the balloon was pulled back out of the stent, the balloon got caught on a stent strut.It was further reported that the balloon then broke in half and part of the tip remained in the vessel as they pulled the whole balloon out of the body.The patient then started to bleed profusely, and they had to apply a tourniquet.The patient was taken to the hospital where a vascular surgeon was able to take the broken off tip out of the vessel.The current status of the patient was unknown.
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: three photos were provided and reviewed.The first photo shows distal end of the balloon with the tip detached and blood residues were noted throughout the detached part.The second image shows the labeling details of the device that match with the information available in trackwise and the third photo shows the vaccess device identified a circumferential rupture in the balloon with blood residues present throughout the balloon.No additional anomalies were observed.Therefore, the investigation is inconclusive for the reported entrapment as reported condition of the issue could not be replicated in the laboratory.However, the investigation is confirmed for the reported detachment as the balloon with the tip was detached and the investigation is identified and confirmed for circumferential balloon rupture based on photos review.A definitive root cause for the reported detachment, entrapment of device and the identified circumferential balloon 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, component, method, result, conclusion).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.

• 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: 23062373
• Report Number: 2020394-2025-01510
• Device Sequence Number: 21250505
• Product Code: LIT
• UDI-Device Identifier: 00801741121265
• UDI-Public: (01)00801741121265(17)280430(10)93RK0154
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: VA80124
• Device Lot Number: 93RK0154
• 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: 08/27/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown