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

Catalog Number	ATG120126
Medical Device Problem Codes	Break (1069); Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
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: the physical device was not returned for evaluation.One video received and reviewed.In the video, a health care professional using unknown inflation device pressurizing the catheter balloon which was broken from the catheter shaft proximally and the balloon was noted be in inverted condition.Further, while pressurizing leak from the porthole near to the proximal end of catheter shaft could be observed.No other anomalies were noted.One fluoroscopic video received and reviewed.In the fluoroscopy video depicts what appears to be angioplasty of the superior vena cava via a right jugular access.The un-inflated balloon has been advanced to the area of interest.Further, the balloon was in not inflated condition and there was no evidence of leak nor rupture could be observed.No other anomalies were noted.Based on the submitted radiographic video, no conclusion could be confirmed but from the real-time received video shows leakage from the proximal end of catheter and balloon had break from the proximal end of catheter joint could be observed.Therefore, the investigation was confirmed for reported leak and identified break issue.However, the investigation remains inconclusive for the reported inflation issue due to device condition in the video and also no sample is available for functional testing.A definitive root cause for the reported leak and inflation, identified break 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: 01/2026), 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, the pta balloon allegedly cannot be filled properly after being sent to the lesion location.It was further reported that there was allegedly a air leakage at the position where the balloon head overlapped with the delivery rod.There was no reported patient injury.

• Brand Name: ATLAS GOLD
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 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: 19707899
• Report Number: 2020394-2024-01001
• Device Sequence Number: 6917424
• Product Code: DQY
• UDI-Device Identifier: 00801741060724
• UDI-Public: (01)00801741060724
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K181323
• 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
• Report Date (Section B): 06/23/2024

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: ATG120126
• Device Lot Number: 93NH0096
• 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: 06/17/2024
• Initial Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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