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

Catalog Number ATG120202

Device Problems Deflation Problem (1149); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/05/2023

Event Type  malfunction  

Event Description

It was reported that during an angioplasty procedure, the pta balloon was completely detached from the shaft.It was further reported the pta balloon allegedly had deflation issue.Reportedly, the detached balloon was able to removed.The procedure was completed using another device.There was no reported patient injury.

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 not been returned to the manufacturer for evaluation.However, an image and photos were provided for review.The investigation of the reported event is currently underway.H10: d4 (expiry date: 07/2025).H11: section a through f - the information provided by bd represents all of 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.Device not returned.

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.Two x-ray images were provided and reviewed.The images show an atlas gold balloon in the aortic arch.There are multiple wires and a large sheath with a balloon expandable stent already placed.There does appear to be a discontinuity of the balloon with the shaft and the markers with the balloon partially inflated.Additionally, two photos were provided and reviewed.The first photo shows the atlas gold balloon inverted and completely detached from the catheter shaft.The second photo shows the distal end of the catheter shaft, with the balloon detached and not seen in the picture.The glue bullet is not seated correctly and unraveled fibers of the balloon are seen near the glue weld.Therefore, the investigation is confirmed for the reported balloon detachment and removal difficulty as the balloon is seen inverted (which would have occurred during removal difficulties), and completely detached from the catheter shaft.A definitive root cause for the alleged balloon detachment and 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.H10: d4 (expiry date: 07/2025), g3, h6 (method).H11: section a through f - the information provided by bd represents all of 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 Description

It was reported that during an angioplasty procedure, the pta balloon was completely detached from the shaft.It was further reported the detached balloon had partially obstructed the vessel.Reportedly, the balloon was removed by unclogging the vessel and then deflating the balloon.There was no reported patient injury.

• Brand Name: ATLAS GOLD
• Type of Device: 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: 17565901
• MDR Text Key: 321722328
• Report Number: 2020394-2023-00584
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801741060922
• UDI-Public: (01)00801741060922
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K181323
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: ATG120202
• Device Lot Number: 93UG0057
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/17/2023
• Supplement Dates Manufacturer Received: 01/05/2024
• Supplement Dates FDA Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 14 YR
• Patient Sex: Female