ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM
Report
- Report Number
- 2134265-2013-01001
- Event Type
- Malfunction
- Date Received
- February 27, 2013
- Date of Event
- January 31, 2013
- Report Date
- January 31, 2013
- Manufacturer
- BOSTON SCIENTIFIC - FREMONT (CE)
- Product Code
- MCX
- PMA / PMN Number
- P900056
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GB
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4). DEVICE EVALUATION BY MANUFACTURER: THE DEVICE HAS NOT BEEN RECEIVED 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).
DEVICE EVALUATED BY MANUFACTURER: EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED THAT THE ROTATIONAL SPEED IN DYNAGLIDE MODE WAS 75 KRPM; THE MAXIMUM TURBINE ROTATIONAL SPEED REACHED WAS 225 KRPM; THE TURBINE SPEED WAS SET TO AND MAINTAINED 170 KRPM. DURING FUNCTIONAL TESTING THE ROTATIONAL SPEED ABRUPTLY DROPS TO 168 KRPM FROM MAXIMUM OF 225 KRPM. THE ROTATIONAL SPEED CONTROL IS LINEAR WHEN INCREASING RPMS FROM MINIMUM TO MAXIMUM. THE FOOT PEDAL FUNCTIONED PROPERLY, READILY ACTIVATING/DEACTIVATING THE BURR ROTATION AND SWITCHING THE CONSOLE BETWEEN TURBINE AND DYNAGLIDE MODES. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).
IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, ROTATIONAL SPEED ADJUSTMENT DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY (LCX). THIS ROTABLATOR CONSOLE WAS SELECTED AND WAS SET UP PER THE INSTRUCTIONS; HOWEVER, WHEN ATTEMPTING TO PLATFORM THE BURR AFTER HAVING THE ROTABLATOR, AIR SUPPLY AND ROTABLATOR ANCILLARIES ALL CORRECTLY CONNECTED, THE PHYSICIAN NOTED THAT THE PRESSURE READING ON THE CONSOLE GAUGE APPEARED TO BE UNUSUALLY HIGH AND DISPLAYED 7 BARR. AFTER MULTIPLE ADJUSTMENTS, THE PHYSICIAN WAS STILL UNABLE TO OBTAIN A REGULATED PRESSURE WHEN TURNING THE CONTROL KNOB ON THE ROTA CONSOLE. IT WAS FURTHER REPORTED THAT THE CONSOLE STAYS AT 200,000 RPM, EVEN IN DYNAGLIDE MODE. THE SPEED WAS LOWERED BY REDUCING THE PRESSURE AT THE REGULATOR. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS STABLE.
IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, ROTATIONAL SPEED ADJUSTMENT DIFFICULTIES WERE ENCOUNTERED. THE TARGET LESION WAS LOCATED IN THE LEFT CIRCUMFLEX ARTERY (LCX). THIS ROTABLATOR CONSOLE WAS SELECTED AND WAS SET UP PER THE INSTRUCTIONS; HOWEVER, WHEN ATTEMPTING TO PLATFORM THE BURR AFTER HAVING THE ROTABLATOR, AIR SUPPLY AND ROTABLATOR ANCILLARIES ALL CORRECTLY CONNECTED, THE PHYSICIAN NOTED THAT THE PRESSURE READING ON THE CONSOLE GAUGE APPEARED TO BE UNUSUALLY HIGH AND DISPLAYED 7 BARR. AFTER MULTIPLE ADJUSTMENTS, THE PHYSICIAN WAS STILL UNABLE TO OBTAIN A REGULATED PRESSURE WHEN TURNING THE CONTROL KNOB ON THE ROTA CONSOLE. IT WAS FURTHER REPORTED THAT THE CONSOLE STAYS AT 200,000 RPM, EVEN IN DYNAGLIDE MODE. THE SPEED WAS LOWERED BY REDUCING THE PRESSURE AT THE REGULATOR. IT WAS REPORTED THAT THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS WAS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 83374 | ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM | CATHETER, CORONARY, ATHERECTOMY | MCX | BOSTON SCIENTIFIC - FREMONT (CE) | 22020-038-L |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |