FDA Adverse Event Malfunction Summary report: N

MAVERICK2 MONORAIL PTCA CATHETER

MDR report key: 1001744 · Received February 19, 2008

Report

Report Number: 2134265-2008-00462
Event Type: Malfunction
Date Received: February 19, 2008
Date of Event: February 7, 2008
Report Date: February 7, 2008
Manufacturer: BOSTON SCIENTIFIC
Product Code: LOX
PMA / PMN Number: P860019/S179
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVAL: THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVAL; 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 INFO FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION (PCI) PROCEDURE, A BALLOON RUPTURE OCCURRED. THE LESION BEING TREATED WAS LOCATED IN THE MODERATELY TORTUOUS, SEVERELY CALCIFIED AND 99% STENOTIC RIGHT CORONARY ARTERY. THE PHYSICIAN FIRST DEPLOYED A STENT. THEN THE PHYSICIAN ADVANCED THE 2.5X20 MM MAVERICK2 BALLOON TO THE LESION AND INFLATED IT TO 12 ATMS FOR TEN SECONDS ON THE FIRST INFLATION. THEN THE PHYSICIAN INFLATED THE BALLOON TO 13 ATMS BETWEEN ONE TO FIVE SECONDS ON THE SECOND INFLATION AND IT RUPTURED. THERE WERE NO PT COMPLICATIONS. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A 3.0X20 QUANTUM MAVERICK BALLOON. PT STATUS IS REPORTED AS "GOOD".

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MAVERICK2 MONORAIL PTCA CATHETER	LOX CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS	LOX	BOSTON SCIENTIFIC	MAVERICK 20 / 2.5	8183277

Patients

Seq	Age	Sex	Outcome	Treatment
1