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

Model Number	AT75186
Medical Device Problem Codes	Difficult to Remove (1528); Retraction Problem (1536); Unraveled Material (1664)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model at75186, pta balloon dilation catheter, allegedly became caught in the stent, was difficult to remove from the patient, and experienced unraveled material.This information was received from a single source.This malfunction involved a patient with no consequences.Patient age, weight, and gender were not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model at75186, pta balloon dilation catheter, allegedly became caught in the stent, was difficult to remove from the patient, and experienced unraveled material.This information was received from a single source.This malfunction involved a patient with no consequences.Patient age, weight, and gender were not provided.
Additional Manufacturer Narrative
H10: the lot number for the malfunction was provided and a lot history review was performed.The investigation is confirmed for the unraveled fibers and inconclusive for the retraction issue.The definitive root cause could not be determined.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 DILATION 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: 9195157
• Report Number: 2020394-2019-03980
• Device Sequence Number: 3671736
• Product Code: LIT
• 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): 01/07/2020

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: GFCY2820
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019
• Initial Report FDA Received Date: 10/15/2019
• Supplement Report FDA Received Date: 01/07/2020
• Patient Sequence Number: 1