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

Catalog Number	AT120164
Medical Device Problem Codes	Deflation Problem (1149); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2025
Type of Reportable Event	Malfunction
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 (lit;dqy) 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
On (b)(6) 2025, a patient underwent a percutaneous transluminal angioplasty (pta) procedure using the atlas pta balloon catheter.During the procedure, the balloon was allegedly slow to deflate.It was further reported that the balloon inflation portion of the catheter may have been bent, and a small blunt needle was inserted into the balloon inflation port to straighten it, and the balloon began to deflate slightly faster.Reportedly, a second balloon was placed alongside the balloon to apply external pressure, and the balloon was deflated and was able to be removed.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: one atlas pta dilatation catheter returned for evaluation.Upon visual inspection it was noted the catheter had one kink near the distal end of the catheter.In addition, there was two narrowing points near the distal end.The balloon was noted to have liquid within.During functional testing, an in-house presto inflation device was used to inflate the device to nominal pressure.The balloon was successfully inflated and maintained pressure.The balloon was then attempted to be deflate and the device deflated within the device's specified deflation time.The catheter was cut distal at kinked place and attached to a touhy borst adapter to be inflated.The balloon inflated to nominal pressure and deflated within the device's specified deflation time.The catheter was cut again distal to the narrowing area and attached to the touhy-borst adapter.The balloon was inflated to nominal pressure and deflated within the device's specified deflation time.No further functional testing was performed.Therefore, the investigation is confirmed for the reported material deformation as narrowing and kinks were noted to the device.However, the investigation is unconfirmed for the reported deflation problem as the balloon deflated within the device's specified deflation time.A definitive root cause for the reported deflation issue and material 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), g2, g3, h3, h6 (method, result, conclusion).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
On (b)(6) 2025, a patient underwent a percutaneous transluminal angioplasty (pta) procedure using the atlas pta balloon catheter.During the procedure, the balloon was allegedly slow to deflate.It was further reported that the balloon inflation portion of the catheter may have been bent, and a small blunt needle was inserted into the balloon inflation port to straighten it, and the balloon began to deflate slightly faster.Reportedly, a second balloon was placed alongside the balloon to apply external pressure, and the balloon was deflated and was able to be removed.There was 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): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 22002473
• Report Number: 2020394-2025-00710
• Device Sequence Number: 7266568
• Product Code: DQY
• UDI-Device Identifier: 00801741062667
• UDI-Public: (01)00801741062667(17)271028(10)GFJW1868
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2025

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: AT120164
• Device Lot Number: GFJW1868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 08/01/2025
• 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