MAUDE Adverse Event Report: BOSTON SCIENTIFIC - FREMONT (CE) ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM; CATHETER, CORONARY, ATHERECTOMY

Model Number H802220200361

Device Problem Air Leak (1008)

Patient Problem No Patient Involvement (2645)

Event Date 01/03/2014

Event Type  malfunction  

Event Description

Reportable based on analysis completed on (b)(4) 2014.It was reported that during preparation for a rotational atherectomy treatment procedure, the rotablator system is loosing pressure.This rotablator rotational atherectomy system was selected; however, during preparation it was reported that the rotablator system was loosing pressure during the intervention.It was noted that the pressure is lost after reaching the console, so there is not enough pressure going to the foot pedal.No patient complications were reported the patient's status is good.However, device analysis revealed that the rotational speed was not displayed in turbine or dynaglide modes, although the burr is rotating.

Manufacturer Narrative

Device evaluated by manufacturer: examination of the returned complaint device revealed that the rotational speed was not displayed in turbine or dynaglide modes, although the burr is rotating.There is a gas/air leak from the turbine pressure switch.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.Given the age of the console, the most likely root cause for the reported difficulties is due to normal wear and tear.(b)(4).

• Brand Name: ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
• Type of Device: CATHETER, CORONARY, ATHERECTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• Manufacturer (Section G): BOSTON SCIENTIFIC - FREMONT (CE); 47215 lakeview blvd; north dock; fremont CA 94538
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3813130
• MDR Text Key: 22137187
• Report Number: 2134265-2014-02606
• Device Sequence Number: 1
• Product Code: MCX
• Combination Product (y/n): N
• PMA/PMN Number: P900056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H802220200361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1