FDA Adverse Event Malfunction Summary report: N

ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

MDR report key: 1792154 · Received August 10, 2010

Report

Report Number: 2134265-2010-03776
Event Type: Malfunction
Date Received: August 10, 2010
Report Date: July 15, 2010
Manufacturer: BOSTON SCIENTIFIC - CORK
Product Code: MCX
PMA / PMN Number: P900056
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4)

Description of Event or Problem · 1

SAME CASE AS 2134265-2010-03773, 2134265-2010-03774, 2134265-2010-03775 AND 2134265-2010-03784. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, UNSTABLE SPEED WAS NOTED. DURING THE PROCEDURE, ATTEMPTS WERE MADE WITH TWO DIFFERENT BURRS, AND BOTH TIMES IT WAS FOUND TO BE IMPOSSIBLE TO ADJUST OR STABILIZE THE ROTATIONAL SPEED OF THE BURR. IT WAS ALSO NOTED THAT "THE EXTREMITY OF THE GUIDE BROKE DURING THE PROCEDURE". THE PROCEDURE WAS UNABLE TO BE COMPLETED, BUT WILL BE COMPLETED AT A LATER DATE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM	CATHETER, CORONARY, ATHERECTOMY	MCX	BOSTON SCIENTIFIC - CORK	UNK552

Patients

Seq	Age	Sex	Outcome	Treatment
1				ROTABLATOR CONSOLE\| ROTAWIRE\| ROTABLATOR BURR (X2)