MAUDE Adverse Event Report: BOSTON SCIENTIFIC GLADIATOR BALLOON 7 X 40MM; CATHETER, ANGIOPLASTY

Model Number H74939207070470

Device Problem Material Rupture (1546)

Patient Problem No Code Available (3191)

Event Date 04/05/2017

Event Type  Injury  

Event Description

Gladiator 7 x 40mm balloon was used to dilate a stenosis in distal right cephalic vein.Balloon ruptured in the middle and as it was retrieved, it was noted that distal half of the balloon stayed inside the fistula over a wire.It was retrieved using a snare device.No balloon fragments left.But, it is of concern that balloon ruptured in to 2 pieces that separated.

• Brand Name: GLADIATOR BALLOON 7 X 40MM
• Type of Device: CATHETER, ANGIOPLASTY
• Manufacturer (Section D): BOSTON SCIENTIFIC ; natick MA 01760
• MDR Report Key: 6471368
• MDR Text Key: 72252889
• Report Number: MW5068969
• Device Sequence Number: 1
• Product Code: LIT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/05/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2020
• Device Model Number: H74939207070470
• Device Lot Number: 20143685
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 54 YR
• Patient Weight: 73