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

Model Number	ATG80142
Medical Device Problem Codes	Break (1069); Unraveled Material (1664); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided for the reported malfunction; therefore, a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported balloon detachment is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model atg80142 pta balloon dilatation catheter allegedly experienced detachment of device component.The information was received from one source.One patient was involved with no reported patient injury.Age, weight and gender were not provided.
Additional Manufacturer Narrative
H10: the lot number was provided for the reported malfunction; therefore, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation.Therefore, the investigation is confirmed for the reported unraveled fiber and break at proximal joint.However, the reported detachment of device was unconfirmed as no evidence can¿t be noted form the evaluation of returned sample.Based upon the available information, the definitive root cause for this event is unknown.The device is labeled for single use.H11: h6(method,result).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
This report summarizes one malfunction.A review of the reported information indicates that model atg80142 pta balloon dilatation catheter allegedly experienced detachment of device component, break and unraveled material.The information was received from one source.One patient was involved with no reported patient injury.Age, weight and gender were not provided.

• 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: 10286804
• Report Number: 2020394-2020-04545
• Device Sequence Number: 515445
• Product Code: DQY
• UDI-Device Identifier: 00801741060731
• UDI-Public: (01)00801741060731
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2021

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: No Information
• Device Model Number: ATG80142
• Device Catalogue Number: ATG80142
• Device Lot Number: 93VC0134
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 07/16/2020
• Supplement Report FDA Received Date: 04/05/2021
• Patient Sequence Number: 1