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

Model Number	ATG80184
Medical Device Problem Codes	Break (1069); Material Rupture (1546); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/24/2019
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 (01/2022).
Event or Problem Description
It was reported that during an angioplasty procedure on the left brachiocephalic vein, the device allegedly broke.Additionally, the balloon detached in the patient and had to be removed through a secondary procedure.
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 (01/2022).(trending device code).
Event or Problem Description
It was reported that during an angioplasty procedure in the left brachiocephalic vein, the pta balloon allegedly ruptured after the second inflation.It was further reported that the balloon allegedly detached in the sheath during retraction.The procedure was concluded and then the patient was sent to the operating room to have the detached balloon segment removed successfully.There were no further reported complications to the patient.

• Brand Name: ATLAS GOLD PTA 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: 8736608
• Report Number: 2020394-2019-01231
• Device Sequence Number: 2091921
• Product Code: LIT
• UDI-Device Identifier: 00801741060878
• UDI-Public: (01)00801741060878
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K181323
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2019

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: ATG80184
• Device Catalogue Number: ATG80184
• Device Lot Number: 93ND0080
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/05/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 06/26/2019
• Supplement Report FDA Received Date: 11/19/2019
• 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: 53 YR
• Patient Weight: 86