FDA Adverse Event Malfunction Summary report: N

ATLANTIS¿ SR PRO

MDR report key: 2880024 · Received December 19, 2012

Report

Report Number: 2134265-2012-08407
Event Type: Malfunction
Date Received: December 19, 2012
Date of Event: November 28, 2012
Report Date: November 28, 2012
Manufacturer: BOSTON SCIENTIFIC - FREMONT (CE)
Product Code: DQO
PMA / PMN Number: K063312
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GB
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(6). (B)(4). AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MANUFACTURER: 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 MFR: 2134265-2012-08213 AND 2134265-2012-08406. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE, THE ILAB ULTRASOUND IMAGING SYSTEM MOTOR DRIVE UNIT FAILED TO PULLBACK. VASCULAR ACCESS WAS OBTAINED VIA THE FEMORAL ARTERY. THE 50% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS AND CALCIFIED PROXIMAL LEFT ANTERIOR DESCENDING ARTERY (LAD). THIS ILAB ULTRASOUND IMAGING SYSTEM MOTOR DRIVE (MDU) WAS SELECTED; HOWEVER, THE MDU FAILED TO PULLBACK DUE TO A LOST COG-WHEEL. IT WAS NOTED THAT THERE WAS NO COG TO ENGAGE THE SLED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THAT PATIENTS STATUS IS STABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ATLANTIS¿ SR PRO	CATHETER, INTRAVASCULAR, DIAGNOSTIC	DQO	BOSTON SCIENTIFIC - FREMONT (CE)	H749389420

Patients

Seq	Age	Sex	Outcome	Treatment
1