MAUDE Adverse Event Report: BOSTON SCIENTIFIC PROMUS PREMIER; STENT

Catalog Number H7493952812300

Device Problem Sticking (1597)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/15/2015

Event Type  malfunction  

Event Description

Promus premier stent balloon lodged inside of guide catheter, md had to remove the wire, lodged balloon and catheter all at once from patient.

• Brand Name: PROMUS PREMIER
• Type of Device: STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 5330172
• MDR Text Key: 34568972
• Report Number: MW5058760
• Device Sequence Number: 1
• Product Code: NIQ
• 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: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: H7493952812300
• Device Lot Number: 18128088
• Other Device ID Number: (01)08714729844679(17)161116
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 66 YR