MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC EMERGE BALLOON

Model Number 2.5X 15MM

Device Problems Break (1069); Kinked (1339)

Patient Problem No Code Available (3191)

Event Date 06/13/2016

Event Type  malfunction  

Event Description

During a procedure, a boston scientific emerge balloon was used and did not seem to be working properly, the balloon was removed from the pt, upon inspection after removal, it was noted the balloon had a kink it in and broke when it was manipulated (outside the pt).

• Brand Name: BOSTON SCIENTIFIC EMERGE BALLOON
• Type of Device: BOSTON SCIENTIFIC EMERGE BALLOON
• Manufacturer (Section D): BOSTON SCIENTIFIC; marlborough MA 01752
• MDR Report Key: 5732625
• MDR Text Key: 47714068
• Report Number: MW5062896
• Device Sequence Number: 1
• Product Code: LOX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/14/2016

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: 12/31/2018
• Device Model Number: 2.5X 15MM
• Device Catalogue Number: 391891525
• Device Lot Number: 19217380
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/14/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 86