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

Model Number	ATG80124
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Occlusion (1984); Device Embedded In Tissue or Plaque (3165)
Date of Event	10/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 09/2021).
Event or Problem Description
It was reported that during an angioplasty procedure in the iliac-femoral venous district, the pta balloon allegedly detached from the shaft while being inflated.It was further reported that a stent was placed in order to block the advancement of the balloon in the vessel.Reportedly, the femoral vein was occluded.It was further reported that another pta balloon dilatation catheter was used to successfully complete the procedure.There was no reported further complications.

• Brand Name: ATLAS GOLD PTA BALLOON DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 9261450
• Report Number: 2020394-2019-04340
• Device Sequence Number: 3660279
• Product Code: DQY
• UDI-Device Identifier: 00801741060694
• UDI-Public: (01)00801741060694
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K181323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/31/2019

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 Model Number: ATG80124
• Device Catalogue Number: ATG80124
• Device Lot Number: 93VC0090
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 41 YR
• Patient Weight: 90