MAUDE Adverse Event Report: PERIPHERAL VASCULAR INC. ATLAS PTA BALLOON DILATATION CATHETER; PERCUTANEOUS CATHETER

Model Number	AT75162
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/17/2017
Type of Reportable Event	Malfunction
Event or Problem Description
Pt underwent fistulogram with balloon angioplasty of the basilic vein, right subclavian vein and right brachiocephalic vein.During ballooning of a constricted area, when balloon was removed from the sheath, they noticed the outer layer of the balloon was shredded.

• Brand Name: ATLAS PTA BALLOON DILATATION CATHETER
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): PERIPHERAL VASCULAR INC.
• MDR Report Key: 7049116
• Report Number: MW5073473
• Device Sequence Number: 11035607
• Product Code: DQY
• UDI-Device Identifier: 00801741062452
• UDI-Public: (01)00801741062452
• 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: 07/28/2020
• Device Model Number: AT75162
• Device Catalogue Number: AT75162
• Device Lot Number: GFBV2350
• 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: 84 YR