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

Catalog Number	AT75124
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	03/20/2025
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 (dqy;lit).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
It was reported that during an angioplasty procedure, the balloon was allegedly difficult to deflate.It was further reported that it did deflate a little and it was withdrawn through the vein and through the sheath without damage.Reportedly, there was difficulty in balloon inflation.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon was allegedly difficult to deflate.It was further reported that it did deflate a little and it was withdrawn through the vein and through the sheath without damage.Reportedly, there was difficulty in balloon inflation and also difficult to remove.There was no reported patient injury.
Additional Manufacturer Narrative
H11: manufacturing review: the device history records have been reviewed, and this lot met all release criteria.Investigation summary: one atlas pta dilatation catheter returned for evaluation.Upon visual inspection, it was noted the distal tip of the balloon was prolapsed.No other anomalies noted on the catheter, bifurcate and luers.During functional testing, an in-house presto inflation device was used to inflate the device and was able to inflate to nominal and rated burst pressure.An attempt was made to deflate the balloon catheter but would not deflate.The balloon was stripped for visibility of the portholes, and no damage was noted to the porthole.In addition, the glue bullet was not visible.The outer catheter was cut longitudinally, and it was noted the glue bullet was within the outer catheter and not seated correctly.No further testing was performed.Therefore, the investigation is confirmed for the reported deflation issue as the glue bullet was within the outer catheter and not seated correctly which could have caused deflation issues.Also, the investigation is confirmed for the reported sheath removal difficulties as the distal tip of the balloon was prolapsed, which could have been caused due to difficulty in removing from the sheath.However, the investigation is unconfirmed for the reported inflation issues as the balloon was able to inflate to nominal and rated burst pressure.A definitive root cause for the reported inflation, deflation and removal difficulties 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.B5, g3, d2b (dqy; lit), d4 (unique identifier (udi) #), h6 (component, device, 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: 21856500
• Report Number: 2020394-2025-00579
• Device Sequence Number: 4684508
• Product Code: DQY
• UDI-Device Identifier: 00801741062407
• UDI-Public: (01)00801741062407(11)250219(17)280128(10)GFKN0460
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/22/2025

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: GFKN0460
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 07/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• 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: 27 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American