MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP ROTOBLATOR; CATHETER, CORONARY, ATHERECTOMY

Model Number M0011401500

Device Problem Kinked (1339)

Patient Problem No Information (3190)

Event Date 06/27/2015

Event Type  malfunction  

Event Description

Rotoblator 1.5 burr and advancer were inserted over the wire.Clinician noticed resistance and removed unit from wire, wiped wire, and made a second attempt to advance unit.Same resistance half way through.Team decided to take apart burr catheter from advancer and noticed that the connector tubes were coiled.Removed device from sterile field and a second device was opened with success.Initial unit never entered the patient's body.

• Brand Name: ROTOBLATOR
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 4881471
• MDR Text Key: 6262165
• Report Number: 4881471
• 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: 06/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: M0011401500
• Device Catalogue Number: 140-150
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2015
• Event Location: Hospital
• Date Report to Manufacturer: 07/01/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 85 YR