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

Catalog Number	AT75204
Medical Device Problem Codes	Deflation Problem (1149); Inflation Problem (1310); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2025
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 return of the sample is pending.However, a video was provided for review.The investigation of the reported event is currently underway.H11: d2b (lit; dqy).H11: 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
It was reported that during an angioplasty procedure, the pta balloon allegedly could not be fully inflated.It was further reported that the pressure balloon allegedly could not be retracted, and the pta balloon allegedly could not be depressurized.Reportedly, the pta balloon was punctured with a puncture needle to withdraw the balloon system.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: the physical device was not returned for evaluation.One image was provided and reviewed.The video shows a partially inflated balloon.The sheath is from the superior aspect of the film.The balloon is partially in the sheath.There is a catheter from the inferior aspect of the film with a catheter and a guided needle to puncture the balloon.This does is done successfully.Therefore, the investigation is confirmed for the reported inflation and deflation issue as balloon was partially inflated and guided needle puncture is present.However, the investigation is inconclusive for the reported removal difficulty as no objective evidence was provided.A definitive root cause for the reported inflation, deflation problem, removal difficulty 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: 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
It was reported that during an angioplasty procedure, the pta balloon allegedly could not be fully inflated.It was further reported that the pressure balloon allegedly could not be retracted, and the pta balloon allegedly could not be depressurized.Reportedly, the pta balloon was punctured with a puncture needle to withdraw the balloon system.The procedure was completed using another device.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: the physical device was not returned for evaluation.One video was provided and reviewed.The video shows a partially inflated balloon.The sheath is from the superior aspect of the film.The balloon is partially in the sheath.There is a catheter from the inferior aspect of the film with a catheter and a guided needle to puncture the balloon.This does is done successfully.Therefore, the investigation is confirmed for the reported inflation, deflation issue and sheath removal issues as guided needle was used to puncture the balloon, which could have caused difficulty in removing through the sheath.A definitive root cause for the reported inflation, deflation problem, removal difficulty could not be determined based upon the provided information.Labelling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.G3, h6 (component, 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
It was reported that during an angioplasty procedure, the pta balloon allegedly could not be fully inflated.It was further reported that the pressure balloon allegedly could not be retracted, and the pta balloon allegedly could not be depressurized.Reportedly, the pta balloon was punctured with a puncture needle to withdraw the balloon system.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: 21429255
• Report Number: 2020394-2025-00200
• Device Sequence Number: 17230574
• Product Code: DQY
• UDI-Device Identifier: 00801741062520
• UDI-Public: (01)00801741062520(17)270528(10)GFJR0281
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup,Followup
• Report Date (Section B): 10/13/2025

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: AT75204
• Device Lot Number: GFJR0281
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2025
• Supplement Date Received by Manufacturer: 04/29/2025; 10/13/2025
• Initial Report FDA Received Date: 02/20/2025
• Supplement Report FDA Received Date: 05/02/2025; 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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