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

Model Number	ATG120142
Medical Device Problem Codes	Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record 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.Medical device expiry date: 04/2024.
Event or Problem Description
It was reported that during an angioplasty procedure, the balloon allegedly ruptured.It was further reported that balloon detached from its shaft.The balloon was removed from patient.There was no patient injury.
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.Five photos were reviewed.The first photo shows the label of the device on which the reported product details could be verified.The second photo shows the detached balloon and catheter with exposed inner guide wire lumen.The third photo shows the distal portion of the catheter with exposed inner guide lumen and marker bands.The fourth photo shows the detached balloon, and the fifth photo shows the device stored within a plastic bag.No other anomalies were noted.Based on the submitted photos, the investigation for the reported balloon rupture remains inconclusive as no evidence of rupture could be observed due to the condition of the detached balloon.However, the investigation was able to be confirmed for the reported detachment as the balloon was noted to be completely detached from the catheter shaft and was able to be observed in the submitted photos.A definitive root cause for the reported balloon rupture and balloon detachment could not be determined based upon the provided information.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4 (expiry date: 04/2024), g3, h6 (method) h11: b5, h6 (result, conclusion) 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 or Problem Description
It was reported that during an angioplasty procedure, the pta balloon allegedly ruptured.It was further reported that the balloon allegedly detached from its shaft.Reportedly, the balloon was removed from the patient.There was no 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 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: 15507204
• Report Number: 2020394-2022-00772
• Device Sequence Number: 5824920
• Product Code: DQY
• UDI-Device Identifier: 00801741060748
• UDI-Public: (01)00801741060748
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• 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): 11/14/2022

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 Model Number: ATG120142
• Device Catalogue Number: ATG120142
• Device Lot Number: 93RG0162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/09/2022
• Supplement Date Received by Manufacturer: 11/14/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 11/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 Age: 7 YR
• Patient Sex: Female