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

Model Number	AT75186
Medical Device Problem Codes	Retraction Problem (1536); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample was returned to the manufacturer for inspection/evaluation.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model at75186 pta balloon dilatation catheter allegedly experienced retraction problem and detachment.This information was received from one source.The malfunction involved patient with no known impact to the patient.Age, sex and weight of the patient were not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model at75186 pta balloon dilatation catheter allegedly experienced retraction problem and detachment.This information was received from one source.The malfunction involved patient with no known impact to the patient.Age, sex and weight of the patient were not provided.
Additional Manufacturer Narrative
H10: the initial mdr was inadvertently submitted with fda rn number as 3011392541.The correct fda rn number was 2020394.H10: the lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was returned to the manufacturer for evaluation.The investigation is confirmed for balloon detachment; however, it is inconclusive for retraction issues.The definitive root cause for the reported balloon detachment and retraction issue could not be determined based upon available information.The device is labeled for single use.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.

• Brand Name: ATLAS 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: 10736588
• Report Number: 3011392541-2020-00010
• Device Sequence Number: 17093394
• Product Code: DQY
• UDI-Device Identifier: 00801741062506
• UDI-Public: (01)00801741062506
• 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): 01/06/2021

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: AT75186
• Device Catalogue Number: AT75186
• Device Lot Number: GFEQ2996
• Initial Date Received by Manufacturer: 09/30/2020
• Supplement Date Received by Manufacturer: 12/31/2020
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 01/06/2021
• Patient Sequence Number: 1