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

Catalog Number	AT120144
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2024
Type of Reportable Event	Malfunction
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 atlas device was returned for evaluation.Upon visual inspection, no kinks noted to the catheter shaft, no anomalies to the luers, bifurcate or glue fillet.The balloon was noted to have peeled pebax at the distal tip of the balloon.An in-house presto inflation device was used to inflate the balloon, and water was noted leaking from the distal tip of the balloon.The balloon fibers were stripped and under microscopic examination a longitudinal rupture was noted at the distal tip of the balloon.No other functional testing performed.One video was received and reviewed.The video shows the medical professional having an atlas balloon in hand.The water is seen streaming outside the balloon through the tip and bubbling up.Therefore, the investigation is confirmed for the reported balloon rupture as a longitudinal rupture was noted to the balloon.Additionally, the investigation is confirmed for the identified peeled pebax since peeled pebax was noted to the distal end of the balloon.A definitive root cause for the alleged balloon rupture and identified peeled pebax 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.H11: d2b (dqy; lit).H11: 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 during an angioplasty procedure, the pta balloon was allegedly leaked from tip at 16 atm.The procedure was completed using another device.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: 21215842
• Report Number: 2020394-2025-00018
• Device Sequence Number: 19664761
• Product Code: DQY
• UDI-Device Identifier: 00801741062636
• UDI-Public: (01)00801741062636(17)261028(10)GFHX1096
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K120971
• 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
• Report Date (Section B): 01/21/2025

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: AT120144
• Device Lot Number: GFHX1096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2025
• Initial Report FDA Received Date: 01/23/2025
• 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 Sex: Unknown