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); Retraction Problem (1536); Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is return for the one malfunction.The company is still investigating the issue at this time.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model atg80184.Pta balloon dilatation catheter allegedly experienced break, retraction problem, and material rapture.This report was received from a single source.This event did involve patient with no reported patient injury.The patient is (b)(6) years of age, the gender is female; however, the weight was not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model atg80184, pta balloon dilatation catheter, allegedly experienced break, retraction problem, and material rupture.This report was received from a single source.This event involved a patient with no reported patient injury.The patient is 61 years of age, the gender is female; however, the weight was not provided.
Additional Manufacturer Narrative
H10: the device was returned for evaluation.The company is still investigating the issue at this time.The devices 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.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model atg80184, pta balloon dilatation catheter, allegedly experienced break, retraction problem, and material rupture.This report was received from a single source.This malfunction involved a patient with no reported patient injury.The patient is 61 years of age, the gender is female; however, the weight was not provided.
Additional Manufacturer Narrative
H10: the lot number for the malfunction is unknown, therefore the manufacturing review could not be conducted.The device was returned for evaluation.The evaluation of the device confirmed for break and retraction issue, however, it is inconclusive for balloon rupture.Based upon the available information, a definitive root cause is unknown.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 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: 8816685
• Report Number: 2020394-2019-01743
• Device Sequence Number: 3027582
• Product Code: LIT
• UDI-Device Identifier: 00801741060878
• UDI-Public: (01)00801741060878
• 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,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: ATG80184
• Device Catalogue Number: ATG80184
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019; 12/31/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 10/12/2019; 01/07/2020
• Patient Sequence Number: 1