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

Model Number	AT120164
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 has been returned to the manufacturer for evaluation.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 (1) malfunction event.A review of the events indicated that model at120164 pta balloon dilatation catheter allegedly experienced a pta balloon rupture.It was further reported that the balloon was not able to be retracted through the 10fr sheath.The health care provider decided to cut the balloon hub and used a 20fr sheath to successfully remove the balloon and 10fr sheath together as one unit.The procedure was concluded, and no further treatment was provided.This report was received from one source.This event involved one patient, age, weight and gender were not provided.This patient had no reported patient injury.
Event or Problem Description
This report summarizes one (1) malfunction event.A review of the events indicated that model at120164 pta balloon dilatation catheter allegedly experienced a rupture.This report was received from one source.This event involved one patient, age, weight and gender were not provided.This patient had no reported patient injury.
Additional Manufacturer Narrative
The lot number was provided, and lot history review was performed.The device was returned for evaluation.The investigation confirmed for a break and retraction issues.The reported rupture was found to be inconclusive.A root cause has not been determined.The device was 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 BALLOON 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: 8516073
• Report Number: 2020394-2019-00317
• Device Sequence Number: 1724159
• Product Code: DQY
• UDI-Device Identifier: 00801741062667
• UDI-Public: (01)00801741062667
• 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): 07/25/2019

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: AT120164
• Device Catalogue Number: AT120164
• Device Lot Number: GFCQ2726
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/15/2019
• Supplement Report FDA Received Date: 07/25/2019
• Patient Sequence Number: 1