MAUDE Adverse Event Report: BOSTON SCIENTIFIC ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY

Model Number 1.5 BURR

Device Problem Disconnection (1171)

Patient Problem No Information (3190)

Event Date 08/13/2014

Event Type  malfunction  

Event Description

Rotablator burr and advancer became disconnected while attempting to platform outside the body.

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC; two scimed place; maple grove MN 55311
• MDR Report Key: 4116844
• MDR Text Key: 4700724
• Report Number: 4116844
• Device Sequence Number: 1
• Product Code: MCX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 08/20/2014

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: Invalid Data
• Device Model Number: 1.5 BURR
• Device Lot Number: 17079939
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/20/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/25/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/20/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 80 YR