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

Catalog Number	VA8068
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2025
Type of Reportable Event	Malfunction
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 return of the sample is pending.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
It was reported that a patient underwent an angioplasty procedure using the vaccess pta balloon during the procedure the balloon allegedly remains stuck inside the sheath.There was no reported patient injury.
Event or Problem Description
A 67-year-old male patient underwent an angioplasty procedure in the radial artery using the vaccess pta balloon for a poorly maturing fistula.During the procedure, the balloon allegedly remains stuck inside the sheath.There were no reported patient injuries.
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 device was returned loaded over a sheath.The proximal end of the balloon was extending out from the distal tip of the sheath.It appeared there was a slight curvature of the portion of the balloon extending out from the sheath.No anomalies noted to the y-body or luers.During functional testing, the device guidewire lumen was flushed.The patency of the guidewire lumen was tested using an in-house guidewire, and it was able to be inserted without issues.An in-house sheath was flushed.Using an in-house presto inflation device, the balloon was subjected to negative pressure and was inserted through the sheath without issue.Balloon was inflated to nominal pressure; the balloon was deflated without issue.The balloon catheter was retracted without no issue through the sheath.No other functional testing performed.Therefore, the investigation is unconfirmed for the reported sheath removal difficulties as the device was able to be inserted and retracted without issue through the sheath.A definitive root cause for the reported sheath removal difficulty issue 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.B5, d2b: (dqy; lit), g3, h6 (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.

• 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: 23060719
• Report Number: 2020394-2025-01506
• Device Sequence Number: 21250380
• Product Code: LIT
• UDI-Device Identifier: 00801741059896
• UDI-Public: (01)00801741059896(17)280507(10)93RK0148
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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: VA8068
• Device Lot Number: 93RK0148
• 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: 08/28/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 12/03/2025
• 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 Age: 67 YR
• Patient Sex: Male
• Patient Weight: 72 KG