MAUDE Adverse Event Report: BARD ATLAS; PTA BALLOON DILATATION CATHETER

Model Number	AT75124
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/26/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Pt underwent fistulogram with balloon angioplasty of the right subclavian and right brachiocephalic vein.During the procedure, the balloon used in the pt's blood vessel appeared to look torn when removed through the sheath.Integrity of balloon was checked by inflating the balloon while on the back table after the tear was discovered.The balloon appeared to have been torn only in the outer layer.

• Brand Name: ATLAS
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): BARD
• MDR Report Key: 7049094
• Report Number: MW5073471
• Device Sequence Number: 11130769
• Product Code: DQY
• UDI-Device Identifier: 00801741062407
• UDI-Public: (01)00801741062407
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/17/2017

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: Health Professional
• Device Expiration Date: 05/28/2020
• Device Model Number: AT75124
• Device Catalogue Number: AT75124
• Device Lot Number: FGBT0355
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 54