MAUDE Adverse Event Report: BOSTON SCIENTIFIC EMERGE MONORAIL

Model Number 39189-1520

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/14/2014

Event Type  Injury  

Event Description

Distal tip of 2.0 x 12 emerge monorail separated from balloon shaft in mid ck during angioplasty procedure.A part of the tip was retrieved by snare; however, the distal tip with distal marker was left embedded after unsuccessful attempts to remove the snare.

• Brand Name: EMERGE MONORAIL
• Type of Device: EMERGE MONORAIL
• Manufacturer (Section D): BOSTON SCIENTIFIC; natick MA 01760
• MDR Report Key: 3704825
• MDR Text Key: 16593990
• Report Number: MW5035226
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/21/2014

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 Model Number: 39189-1520
• Device Catalogue Number: 39189-1520
• Device Lot Number: 16558630
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/24/2014
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Treatment: GUIDELINER; MULTIPLE BALLOONS; PROMUS STENTS; FINECROSS; TORNUS; ROTABLATOR
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Weight: 99