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

Catalog Number	AT75124
Medical Device Problem Code	Deflation Problem (1149)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2025
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 will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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.
Event or Problem Description
A patient underwent an angioplasty procedure using the atlas pta balloon.During the procedure the balloon allegedly would not deflate.The procedure was completed using a needle to pop the balloon.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: received one atlas pta balloon catheter.Upon visual inspection, it was noted an unknown sheath loaded over the balloon.The distal tip of the of sheath was flared and extending out was the distal tip of the balloon.The distal tip of the balloon was partially inflated with bloody water within.No anomalies noted to the bifurcate or luers.During functional testing an in-house presto inflation device was attempted to be used to inflate the device, but it was unable to be inflated.The catheter was cut distal to the kinks and attached to a touhy-borst adapter to be inflated but was still unable to inflate.The balloon was cut, and the proximal balloon joint was examined under magnification.Blood was seen in the balloon and balloon inflation ports.The glue bullet was not seated correctly on the catheter shaft but was rather within the catheter shaft.The inner gw lumen was pulled distally and thus pulling the glue bullet from within the catheter.Dimensional evaluation was conducted of the glue bullet.No further testing was performed.Therefore, the investigation is confirmed for the reported deflation problem as the glue bullet was not seated properly which cause the deflating issue.A definitive root cause for the reported deflation problem 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.B3, b5, d2b (lit; dqy), e1, g1, g3, h6 (method, result).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 74-year-old female patient underwent an angioplasty procedure using the atlas pta balloon.During the procedure, the balloon allegedly wouldn't deflate.The procedure was completed using a needle to pop the balloon.There were no reported patient injury.

• Brand Name: ATLAS
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 23366944
• Report Number: 2020394-2025-01750
• Device Sequence Number: 15677054
• Product Code: LIT
• UDI-Device Identifier: 00801741062407
• UDI-Public: (01)00801741062407(17)280630(10)REKU1526
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K120971
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: AT75124
• Device Lot Number: REKU1526
• 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: 10/03/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 10/23/2025
• Supplement Report FDA Received Date: 12/23/2025
• 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: 73 YR
• Patient Sex: Female