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

Catalog Number 22782-001A

Device Problem Pressure Problem (3012)

Patient Problem No Information (3190)

Event Date 08/14/2014

Event Type  malfunction  

Event Description

Cv advancer would not maintain pressure, kept stalling.

• 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: 4116826
• MDR Text Key: 4921739
• Report Number: 4116826
• 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

• Date FDA Received: 08/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 22782-001A
• Device Lot Number: 16893740
• Was Device Available for Evaluation?: No
• 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
• Patient Sequence Number: 1
• Patient Age: 65 YR