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

Catalog Number	AT75184
Medical Device Problem Codes	Material Frayed (1262); Inflation Problem (1310); Unraveled Material (1664); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2024
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.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 04/2026).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 in popliteal vein via iliac vein stenosis, the pta balloon was allegedly failed to inflate situ upon inspection.It was further reported that the midsection of the balloon was found to be constrained.The balloon worked successfully for the first 2 inflations and the patient received adequate therapy.Reportedly, some dislodged fibers were reported.There was no reported patient injury.
Event or Problem Description
It was reported that during an angioplasty procedure in popliteal vein via iliac vein stenosis, the pta balloon was allegedly failed to inflate situ upon inspection.It was further reported that the midsection of the balloon was found to be constrained.The balloon worked successfully for the first 2 inflations and the patient received adequate therapy.Reportedly, some dislodged fibers were reported.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: one pta dilatation catheter received for evaluation.During visual analysis fiber disturbance, material frayed, material unraveled, and balloon constrained near to distal end could be observed.No other anomalies were noted.On functional testing the balloon inflated by the inhouse inflation device and could observed the balloon abnormal inflation due to the balloon constrained.And could identified the balloon inflated, maintained pressure, deflated without other issues.No other testing was performed.Three photos received and reviewed.In the first and second photo could observed the balloon part of device and the balloon unraveled near to the proximal end.And in third photo could observed that health care professional holding the balloon which unraveled balloon material made constrained in the balloon further the unraveled material hanging from the balloon.No other anomalies were noted.Based on the photos, return sample visual analysis fiber disturbance, material frayed, material unraveled, and balloon constrained could be noted.Further in functional testing could observed abnormal inflation due to the balloon constrained.Hence the investigation was confirmed for the reported material deformation, material unraveled and identified material frayed issues.A definitive root cause for the reported material deformation, material unraveled and identified material frayed issues 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.H10: d4 (expiration date: 04/2026), g3, h6 (device, method).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.

• 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: 19349908
• Report Number: 2020394-2024-00654
• Device Sequence Number: 12615730
• Product Code: DQY
• UDI-Device Identifier: 00801741062490
• UDI-Public: (01)00801741062490
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Report Date (Section B): 06/20/2024

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: AT75184
• Device Lot Number: GFHR2821
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 06/21/2024
• 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