MAUDE Adverse Event Report: BOSTON SCIENTIFIC FLEXTOME CUTTING BALLOON 8MM X 2CM OTW

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problem Tissue Damage (2104)

Event Date 01/13/2014

Event Type  Injury  

Event Description

An 8mm diameter by 2cm length boston scientific flextome over the wire cutting angioplasty balloon catheter was used to enlarge an atrial septal defect in a child on ecmo for dilated cardiomyopathy.The procedure was needed to decompress the left atrium.The package insert rated the profile of the balloon for a 7fr delivery sheath and a 7fr long mullins sheath was inserted across the atrial septal defect into the left atrium.The balloon was inserted without difficulty across the atrial septal defect and the sheath was pulled back into the ivc.The balloon was inflated to rbp of 10 atm without difficulty and deflated slowly (1 atm every 5 sec) then rotated and inflated a second time.Upon deflation, it was clear that the balloon had not completely deflated despite significant negative pressure being applied at the inflation device.The balloon could not be resheathed into the 7fr sheath despite numerous attempts and required removal via surgical cutdown of the right femoral vein.A 6mm flextome cutting balloon and a 12mm tyshakii angioplasty balloon were used before the 8mm cutting balloon was used.

• Brand Name: FLEXTOME CUTTING BALLOON 8MM X 2CM OTW
• Type of Device: FLEXTOME CUTTING BALLOON
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 3596874
• MDR Text Key: 18794771
• Report Number: MW5033980
• Device Sequence Number: 1
• Product Code: NWX
• 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: 01/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 MO
• Patient Weight: 10