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

Model Number H802220200281

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the device has not been returned for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that the turbine pressure control knob cannot control the speed.A 220v rotablator rotational atherectomy system was selected for treatment.During preparation, it was noted that the manometer was not able to reach the maximum speed continuously.Also, the knob speed adjustment does not result in a smooth running of the manometer button.After the procedure, it was also noted that the event timer did not reset to 00:00 and the counting does not start when a new procedure is started.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status is stable.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The console's void seal was broken.A stain was noted on the foot pedal.An attempt was made to test the console and foot pedal using a rotalink 1.75mm burr.The console could not be tested as there is no rotational speed display due to a massive gas/air leak at the turbine pressure switch and there is no burr rotation.The foot pedal functioned properly, readily activating/deactivating the burr rotation and switching the console between turbine and dynaglide modes.The console exhibited a massive gas/air leak at the turbine pressure switch, which will cause the console to fail to enter turbine mode.The pressure switch incorporates a polyurethane diaphragm which is subjected to gas/air pressure during console operation.As the diaphragm material deteriorates over time and/or through normal use, the diaphragm can develop a gas/air leak.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The root cause has been determined to be wear and tear.(b)(4).

Event Description

It was reported that the turbine pressure control knob cannot control the speed.A 220v rotablator rotational atherectomy system was selected for treatment.During preparation, it was noted that the manometer was not able to reach the maximum speed continuously.Also, the knob speed adjustment does not result in a smooth running of the manometer button.After the procedure, it was also noted that the event timer did not reset to 00:00 and the counting does not start when a new procedure is started.The procedure was completed with another of the same device.There were no patient complications reported and the patient's status is stable.

• 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: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5440571
• MDR Text Key: 38294547
• Report Number: 2134265-2016-01082
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H802220200281
• Device Catalogue Number: 22020-028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1