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U.S. Department of Health and Human Services

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

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BARD PERIPHERAL VASCULAR, INC. ATLAS GOLD; PTA BALLOON DILATATION CATHETER Back to Search Results
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.
 
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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 Key17565901
MDR Text Key321722328
Report Number2020394-2023-00584
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00801741060922
UDI-Public(01)00801741060922
Combination Product (y/n)N
Reporter Country CodeCI
PMA/PMN Number
K181323
Number of Events Reported1
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 NumberATG120202
Device Lot Number93UG0057
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/24/2023
Initial Date FDA Received08/17/2023
Supplement Dates Manufacturer Received01/05/2024
Supplement Dates FDA Received01/08/2024
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 Number1
Patient Age14 YR
Patient SexFemale
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