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

Catalog Number	VA8088
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2026, a patient underwent a percutaneous transluminal angioplasty (pta) procedure using the vaccess balloon catheter.During the procedure, the balloon catheter was allegedly unable to be removed from the sheath.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H11: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.D2b (lit; dqy) 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.
Additional Manufacturer Narrative
H11: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: one vaccess pta catheter returned for evaluation.Upon visual inspection, kink was observed on the catheter shaft.No anomalies were noted at the y body.Buckling was observed at the distal tip of the returned sheath, with the catheter stuck inside and bulging noted at the balloon distal tip.During functional testing, an attempt was made to remove the balloon from the returned sheath, but due to the bulging of the balloon the attempt was unsuccessful, no other functional testing was performed.One photo was provided and reviewed.The photo shows the vaccess pta dilatation catheter with an unknown brand sheath loaded onto it.Kink was noted on the shaft.Blood residues were noted to the balloon.No other anomalies were noted.Four fluoroscopic images were provided and reviewed.There are several photos of an arteriovenous graft.A sheath with a wire has been placed toward the venous anastomosis.There is a stent.There is also a kmp catheter in the brachial artery for a second access site.The second image is similar with a finger compressing the stented segment.The kmp catheter has been removed.The wire extends to mid stent.The third image is similar to the first with a finger compressing the graft near the sheath on the arterial side.The final image is a fistula gram with flow through the stented segment.The images do not show the balloon catheter and are not in a particular order.Therefore, the investigation is confirmed for the reported sheath removal issue and identified material deformation as bulging was also noted to the balloon, which would have been caused removal difficulties and attempts to remove the sheath was unsuccessful.Also, the investigation is confirmed for the identified material deformation as kink was noted on the catheter shaft.A definitive root cause for the reported sheath removal difficulty and identified deformation 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 (lit; dqy), 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.
Event or Problem Description
On (b)(6) 2026, a patient underwent a percutaneous transluminal angioplasty (pta) procedure using the vaccess balloon catheter.During the procedure, the balloon catheter was allegedly unable to be removed from the sheath.The procedure was completed using another device.There was no reported patient injury.

• 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: 24232125
• Report Number: 2020394-2026-00110
• Device Sequence Number: 18387553
• Product Code: LIT
• UDI-Device Identifier: 00801741059971
• UDI-Public: (01)00801741059971
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 04/02/2026

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: VA8088
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2026
• Supplement Date Received by Manufacturer: 04/01/2026
• Initial Report FDA Received Date: 02/02/2026
• Supplement Report FDA Received Date: 04/07/2026
• 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