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

Model Number	AT75186
Medical Device Problem Codes	Retraction Problem (1536); Material Rupture (1546); Detachment of Device or Device Component (2907)
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 event indicated that model at75186 pta balloon dilatation catheter.Reportedly, the pta balloon allegedly ruptured at 12atm during the second inflation attempt.It was further reported that there was difficulty removing the balloon through the sheath.Upon removing the balloon through the sheath, a segment of the balloon allegedly detached but was successfully removed from the patient.Another balloon was used to complete the procedure.The procedure was completed with another device.This report was received from one source.This event involved one patient with no reported patient injury.
Additional Manufacturer Narrative
The lot number for the device was provided and a lot history review was performed.The device was returned for evaluation.A visual inspection did not find any evidence of detachment; all joints were intact.An attempt was made to inflate the device and a pinhole rupture was identified on the balloon.Therefore, the investigation is unconfirmed for the reported detachment, and is confirmed for a pinhole rupture.However, the investigation is inconclusive for the reported retraction issue as further functional testing was not viable, due to the rupture.The device is labeled for single use.
Event or Problem Description
This report summarizes one (1) malfunction event.A review of the event indicated that model at75186 pta balloon dilatation catheter allegedly experienced detachment of device or device component, retraction problem and material rupture.This report was received from a single source.This event did involve patient with no patient consequences.Age, weight, and gender were not provided for the patient.

• 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: 8520626
• Report Number: 2020394-2019-00361
• Device Sequence Number: 16624450
• 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,Followup
• Report Date (Section B): 07/24/2019

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: GFCY2820
• Initial Date Received by Manufacturer: 03/31/2019
• Supplement Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 07/24/2019
• Patient Sequence Number: 1