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

Model Number	ATG120162
Medical Device Problem Codes	Deflation Problem (1149); 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
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model atg120162 pta balloon dilatation catheter allegedly experienced deflation problem.This report was received from one source.This malfunction involved one patient with no patient consequences.Age, weight, and gender were not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model atg120162 pta balloon dilatation catheter allegedly experienced deflation problem, detachment and retraction issue.This report was received from one source.This malfunction involved one patient with no patient consequences.The 90 year old male patient weight was not provided.
Additional Manufacturer Narrative
H10: the complaint was reassessed for reportability and determined to be reportable as a serious injury is reported under emdr number 2020394-2020-06418.H10: as the lot number for the device was provided, a lot history review was performed.The device was returned to the manufacturer for evaluation.The investigation is confirmed for the reported detachment and retraction issue; however, the investigation is inconclusive for the reported deflation issue.A definitive root cause for the reported event 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 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: 10736568
• Report Number: 2020394-2020-06076
• Device Sequence Number: 13981587
• Product Code: DQY
• UDI-Device Identifier: 00801741060809
• UDI-Public: (01)00801741060809
• 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: ATG120162
• Device Catalogue Number: ATG120162
• Device Lot Number: 93XD0079
• 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