FDA Adverse Event Malfunction Summary report: N

ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

MDR report key: 3103103 · Received May 9, 2013

Report

Report Number: 2134265-2013-03082
Event Type: Malfunction
Date Received: May 9, 2013
Date of Event: April 11, 2013
Report Date: April 11, 2013
Manufacturer: BOSTON SCIENTIFIC - FREMONT (CE)
Product Code: MCX
PMA / PMN Number: P900056
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). 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

IT WAS REPORTED THAT DURING AN ATHERECTOMY AND STENTING TREATMENT PROCEDURE, ROTATIONAL SPEED ADJUSTMENT DIFFICULTIES WERE ENCOUNTERED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 70% TO 90% STENOSED TARGET LESION WAS LOCATED IN THE NON-TORTUOUS AND MODERATELY CALCIFIED MID LEFT ANTERIOR DESCENDING (LAD). IT WAS REPORTED THAT THE TURBINE PRESSURE WAS UNABLE TO BE ADJUSTED FROM 210,00 RPM AND THE SPEED OF THE DEVICE DID NOT RESPOND WHEN THE KNOB WAS TURNED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. IT WAS NOTED THAT AFTER THE PROCEDURE A BIOMEDICAL ENGINEER TIGHTENED THE SCREWS ON THE BUTTON OF THE SPEED CONTROL. NO PATIENT COMPLICATIONS WERE REPORTED AND THAT PATIENT'S STATUS IS STABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
204269	ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM	CATHETER, CORONARY, ATHERECTOMY	MCX	BOSTON SCIENTIFIC - FREMONT (CE)	H802220200381

Patients

Seq	Age	Sex	Outcome	Treatment
1	84 YR			GUIDE CATHETER: 6F XB3.5