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

Model Number	ATG80146
Medical Device Problem Codes	Break (1069); Retraction Problem (1536)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device for this event has been returned to the manufacturer for evaluation.The investigation identified retraction issues.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.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 an atg80146 pta balloon dilatation catheter allegedly experienced a retraction problem.This information was received from one source.The retraction problem involved one patient with no patient consequence.The age, weight, and sex were not reported for the patient involved.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that an atg80146 pta balloon dilatation catheter allegedly experienced a retraction problem.This information was received from one source.The retraction problem involved one patient with no patient consequence.The age, weight, and sex were not reported for the patient involved.
Additional Manufacturer Narrative
The device for this event has been returned to the manufacturer for evaluation.The investigation is confirmed for the identified weld break, as the balloon was shown to be welded to the catheter shaft before breaking.The investigation is inconclusive for the reported retraction issue, as the sheath was not returned and no damage shows retraction issue.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.

• 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: 8811697
• Report Number: 2020394-2019-01650
• Device Sequence Number: 2541319
• Product Code: LIT
• UDI-Device Identifier: 00801741060779
• UDI-Public: (01)00801741060779
• 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): 10/08/2019

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: ATG80146
• Device Catalogue Number: ATG80146
• Device Lot Number: 93YC0158
• Initial Date Received by Manufacturer: 06/30/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 07/22/2019
• Supplement Report FDA Received Date: 10/08/2019
• Patient Sequence Number: 1