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	07/17/2025
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 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 male patient underwent an angioplasty procedure in cephalic vein using the atlas pta balloon.During the procedure the balloon allegedly would not deflate.It was further reported that a needle through patient's chest wall was used to puncture the balloon to deflate it.Reportedly, after deflating with needle puncture, the procedure was able to continue without issue.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2025, a male patient underwent an angioplasty procedure in cephalic vein using the atlas pta balloon.During the procedure the balloon allegedly would not deflate.It was further reported that a needle through patient's chest wall was used to puncture the balloon to deflate it.Reportedly, after deflating with needle puncture, the procedure was able to continue without issue.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 balloon was returned loaded within a sheath.The sheath had a buckled distal end and the tubing connected to the hub was bloody.The balloon was received deflated and bloody, and the catheter shaft was noted to be narrow.During functional testing, an in-house presto inflation device was used to inflate the device to nominal pressure, but it was unable to be inflated.An attempt was made to inflate to rpb and was not able to be inflated.The catheter was cut proximal to the narrow point present on the catheter and attached to a touhy-borst adapter to be inflated but was still unable to inflate.The catheter was cut a second time, this time distal to the narrow portion and attached to the touhy-borst adapter and was not able to be inflated.The balloon was cut and it was noted the glue bullet was not seated correctly on the outer catheter but was rather within the catheter.Dried blood was noted on the inflation ports.No further testing was performed.Therefore, the investigation is confirmed for the reported deflation problem as glue bullet was not seated correctly on the outer catheter, which could have caused deflation issues.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.D2b (dqy;lit).G3, h6 (component, 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.

• 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: 22892281
• Report Number: 2020394-2025-01338
• Device Sequence Number: 8852188
• Product Code: LIT
• UDI-Device Identifier: 00801741062407
• UDI-Public: (01)00801741062407(17)270528(10)GFJR0248
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 11/05/2025

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: GFJR0248
• 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: 07/30/2025
• Supplement Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 11/10/2025
• 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: Male