MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC EMERGE PUSH BALLOON CATHETER

Model Number 1.50 MMX 15 MM

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/11/2017

Event Type  Injury  

Event Description

Peripheral ballooning being done to left leg.Used a boston scientific coronary emerge push balloon in the leg.Md noted a portion of balloon broke off into peripheral artery.Md was able to use precise technique with additional balloon to snare broken off balloon piece and remove it safely from the patient.No adverse event noted.Boston scientific notified.Equipment was saved and awaiting vendor to pick up.

• Brand Name: BOSTON SCIENTIFIC EMERGE PUSH BALLOON CATHETER
• Type of Device: EMERGE PUSH BALLOON CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC; maple grove MN 55311
• MDR Report Key: 7138509
• MDR Text Key: 95613143
• Report Number: MW5074157
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 0871429806011
• UDI-Public: (01)0871429806011(17)190831(10)
• Combination Product (y/n): N
• 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: 12/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: 1.50 MMX 15 MM
• Device Catalogue Number: H7493919015150
• Device Lot Number: 20111535
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 66 YR
• Patient Weight: 123