MAUDE Adverse Event Report: BOSTON SCIENTIFIC MUSTANG BALLOON

Model Number H74939171100470

Device Problems Material Rupture (1546); Defective Device (2588)

Patient Problem No Information (3190)

Event Date 08/03/2017

Event Type  Injury  

Event Description

Av fistula who underwent routine fistula reassessment and dedicated venoplasty on (b)(6) 2017 which was complicated by venoplasty balloon rupture, potentially related to a defective balloon. Specifically, balloon rupture occurred between 8-10 atm pressure, well below the related burst pressure of 16 atm. The dominant radiopaque balloon fragment that could be visualized fluoroscopically was successfully snared and removed prior to conclusion of the (b)(6) 2017 procedure. The remaining piece of the balloon was successfully removed by thoracic surgeon on (b)(6) 2017.

• Brand Name: MUSTANG BALLOON
• Type of Device: MUSTANG BALLOON
• Manufacturer (Section D): BOSTON SCIENTIFIC; castle rock CO 80108
• MDR Report Key: 6791397
• Report Number: MW5071540
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 08/31/2017
• Device Model Number: H74939171100470
• Device Lot Number: 20327135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

• Patient Age: 52 YR
• Patient Weight: 103
• Patient Outcome(s): Required Intervention