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

Catalog Number	ATG80166
Medical Device Problem Codes	Break (1069); Deflation Problem (1149); Difficult to Remove (1528); Unraveled Material (1664); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2025
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 device has not been returned to the manufacturer for evaluation.However, photos were provided for review.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 patient underwent an angioplasty procedure using the atlas gold pta balloon.During the procedure, the balloon allegedly did not deflate.It was further reported that the inflated balloon had shifted on the catheter.There was no reported patient injury.
Event or Problem Description
On (b)(6) 2025, a patient underwent an angioplasty procedure using the atlas gold pta balloon.During the procedure, the balloon allegedly did not deflate.It was further reported that the inflated balloon had shifted on the catheter.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.Four photos were provided and reviewed.The first photo shows the healthcare professional holding the atlas gold device.Blood residues were seen throughout the balloon.The distal tip of the balloon was bend and balloon fibers were seen unraveled at the distal end.No other anomalies were noted.The second photo shows the atlas gold balloon with blood residues throughout.Distal end of the balloon was not visible in the provided photo.Bunching was noted on the catheter shaft near to the proximal end of the balloon.Glue bullet was seen near to the bunching site, not seated properly on the catheter.Unraveling of balloon fibers were seen at the proximal end of the balloon.The third photo shows the healthcare professional holding the atlas gold device.The device was noted to be detached (hcp holding one part of device in one hand and the other part in opposite hand).Blood residues were seen throughout the balloon.Unraveling was noted at both ends of the balloon.Bunching was noted at the shaft near proximal end of the balloon.The fourth photo shows the healthcare professional holding the one detached part of atlas gold device.The distal tip of the balloon was bend and balloon fibers were seen unraveled at the proximal end.Bunching was noted on the catheter shaft.No other anomalies were noted.Based on the photo provided, the investigation was confirmed for the reported detachment as the device was seen detached in two segments.Also, the investigation is confirmed for the reported deflation problem and identified sheath removal issues as glue bullet was not seated correctly on the catheter shaft.The investigation is confirmed for the identified material deformation as bunching was noted on the catheter shaft and distal tip of the balloon appeared to be bent.The investigation is confirmed for the identified unraveled material as balloon fibers were noted to be unraveled from both ends of the balloon.A definitive root cause for the reported deflation, detachment, identified material deformation, unraveled material, sheath removal 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.D2b: (dqy; lit), g3, h6 (device, 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.
Event or Problem Description
On (b)(6) 2025, a patient underwent an angioplasty procedure using the atlas gold pta balloon.During the procedure, the balloon allegedly did not deflate.It was further reported that the inflated balloon had shifted on the catheter.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.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: although the physical device was not returned for evaluation, four photos were provided and reviewed.The photos show different portions of the atlas gold device appearing to be in two segments.The balloon and inner lumen seem to be completely detached from the outer portion of the catheter shaft.The balloon appears to be still attached to the inner lumen.Bunching can be seen to the inner lumen proximally to the glue bullet.The balloon fibers were seen unraveled on the balloon near the distal tip.The balloon appears to possibly be inverted, but it is unable to be determined based on the images alone.Based on the photo provided, the investigation was confirmed for the reported detachment and identified difficult to remove as the device was seen detached in two segments.The investigation is confirmed for the identified device break, as the balloon appears to be broken from one balloon joint on the device.The investigation is confirmed for the identified material deformation as bunching was noted on the inner lumen.The investigation is confirmed for the identified unraveled material as balloon fibers were noted to be unraveled on the balloon.However, the investigation remains inconclusive for the reported deflation issues, as the device was unable to be tested for the issues deflating.It is likely that the reported deflation issues led to difficulty removing the balloon.The removal issues then likely contributed to the confirmed detachment, break and deformation issues.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required d4 (unique identifier (udi) #), g3, h6 (device, component, method, result).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 GOLD
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): FUTUREMATRIX INTERVENTIONAL; 1605 enterprise street; athens 75751
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 23003054
• Report Number: 2020394-2025-01448
• Device Sequence Number: 9519017
• Product Code: LIT
• UDI-Device Identifier: 00801741060830
• UDI-Public: (01)00801741060830(11)250312(17)280311(10)93QK0014
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K181323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2026

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: ATG80166
• Device Lot Number: 93QK0014
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 12/02/2025; 01/09/2026
• Initial Report FDA Received Date: 09/09/2025
• Supplement Report FDA Received Date: 12/05/2025; 01/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2025
• 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 Sex: Unknown