FDA Adverse Event Malfunction Summary report: N

GALAXY INTRAVASCULAR ULTRASOUND SYSTEM

MDR report key: 3253000 · Received July 29, 2013

Report

Report Number: 2134265-2013-05197
Event Type: Malfunction
Date Received: July 29, 2013
Report Date: July 5, 2013
Manufacturer: BOSTON SCIENTIFIC - FREMONT (SUD)
Product Code: IYO
PMA / PMN Number: K980851
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED 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 MDR ID 2134265-2013-05196 AND 2134265-2013-05198. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, THE MOTOR DRIVE UNIT WAS UNABLE TO PERFORM PULLBACK. THE 75% STENOSED AND MILDLY CALCIFIED LESION WAS LOCATED AT THE LEFT ANTERIOR DESCENDING ARTERY. THE ILAB MOTOR DRIVE UNIT WAS USED IN CONJUNCTION WITH ATLANTIS SR PRO2 INTENDED TO VISUALIZE THE LESION. IT WAS NOTED THAT DURING PROCEDURE THE MOTOR DRIVE UNIT WAS UNABLE TO PERFORM PULLBACK BECAUSE THE CLUTCH LEVER WAS DISABLED. AUTOMATIC PULLBACK WAS ATTEMPTED 2 TO 3 TIMES AND THEY PERFORMED MANUAL PULLBACK. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
352658	GALAXY INTRAVASCULAR ULTRASOUND SYSTEM	SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC	IYO	BOSTON SCIENTIFIC - FREMONT (SUD)	H749A70200

Patients

Seq	Age	Sex	Outcome	Treatment
1