MAUDE Adverse Event Report: C.R. BARD, INC. (GFO) ATLAS PTA BALLOON DILATATION CATHETER

Model Number	AT75186
Medical Device Problem Codes	Material Frayed (1262); Material Rupture (1546); 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 (1) malfunction event.A review of the event indicated that model at75186 pta balloon dilatation catheter during an angioplasty procedure of a calcified lesion in the right common iliac vein, the pta balloon allegedly ruptured at 10atm during the fourth inflation attempt.The balloon was exchanged over the guidewire for another balloon that was used to complete the procedure.This report was received from one source.This event involved one female patient, (b)(6) years of age and (b)(6) lbs.This patient had no reported patient injury.

• Brand Name: ATLAS PTA BALLOON DILATATION CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (GFO); 289 bay road; queensbury NY 12804
• MDR Report Key: 8520689
• Report Number: 2020394-2019-00366
• Device Sequence Number: 11224065
• Product Code: DQY
• 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
• Report Date (Section B): 04/16/2019

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: AT75186
• Device Catalogue Number: AT75186
• Device Lot Number: GFCY2089
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2019
• Initial Report FDA Received Date: 04/16/2019
• Patient Sequence Number: 1