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

Catalog Number	VA5054
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly cannot be deflated at 24 atm.It was further reported that after repeated inflation, deflation, and balloon rotation, deflation was achieved.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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.During visual evaluation, it was noted the balloon catheter was partially inflated.No anomalies were noted to the catheter, luers and y body.An unknown inflation device was returned as well with saline inside the device.During functional testing, the patency of the guidewire lumen was tested using an in-house guidewire, and it was able to pass with no issues.The returned inflation device was used to inflate and deflate the balloon without issue.The balloon deflation time was approximately 4 seconds.No further testing was performed.Therefore, the investigation is unconfirmed for the reported deflation issue as the balloon inflated and deflated without any issues, and the deflation time was within acceptable range of the product specification.A definitive root cause for the reported deflation 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.H10: e1, g3, h6 (method).H11: d2b (dqy; lit), h6 (component, result, conclusion).H11: 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
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.The investigation of the reported event is currently underway.H11: d2b (dqy;lit).H11: 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.
Event or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly cannot be deflated at 24 atm.It was further reported that after repeated inflation, deflation, and balloon rotation, deflation was achieved.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: 21781195
• Report Number: 2020394-2025-00461
• Device Sequence Number: 8636205
• Product Code: LIT
• UDI-Device Identifier: 00801741059636
• UDI-Public: (01)00801741059636(17)270320(10)93QJ0113
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K111850
• 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): 06/02/2025

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: VA5054
• Device Lot Number: 93QJ0113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/10/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 04/05/2025
• Supplement Report FDA Received Date: 06/05/2025
• 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