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

Catalog Number	ATG120146
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	06/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The device has not been returned to the manufacturer for evaluation.However, images were received for review.The investigation of the reported event is currently underway.H11: d2b (dqy;lit) 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 post an angioplasty procedure in iliac vein, it was noted that the patient allegedly experienced thrombus.Reportedly, the thrombus was allegedly retrieved from the patient.The procedure was completed using another device.The current status of the patient was unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the physical device was not returned for evaluation.One image (13 photos and x-ray images) was reviewed by eric wellons.There is a photo of patient's legs.There is an ultrasound indicating thrombus.There is a ct demonstrating an ivf and iliac vein compression.There is a reconstruction image of this.There are multiple x-rays with balloons dilated in the iliac veins.Also, with stents placed in the left iliac vein.A final image demonstrates good flow through the treated veins.There is also a x-ray of an occluded right femoral vein with an intravenous ultrasound image.There is a photo of the clot retrieved from the stent.The final two pages of x-rays show an atlas gold being dilation as well as a mustang balloon.There is no evidence of a problem in the images.Therefore, the investigation is inconclusive for the reported adverse event as no objective evidence was provided for review.Based upon the available information, the definitive root cause is unknown labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g3, h6 (method).H11: h6 (result, conclusion).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 post an angioplasty procedure in the iliac vein, it was noted that the patient allegedly experienced thrombus.Reportedly, the thrombus was retrieved from the patient.The procedure was completed using another device.The current status of the patient was unknown.

• 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: 20264701
• Report Number: 2020394-2024-01451
• Device Sequence Number: 8704370
• Product Code: DQY
• UDI-Device Identifier: 00801741060786
• UDI-Public: (01)00801741060786
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 12/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ATG120146
• Device Lot Number: UNKNOWN
• 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: 08/24/2024
• Supplement Date Received by Manufacturer: 12/27/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 01/18/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Patient Weight: 69 KG