FDA Adverse Event Malfunction Summary report: N

MAVERICK2 BALLOON CATHETER

MDR report key: 1911116 · Received November 30, 2010

Report

Report Number: 2134265-2010-05182
Event Type: Malfunction
Date Received: November 30, 2010
Date of Event: November 4, 2010
Report Date: November 5, 2010
Manufacturer: BOSTON SCIENTIFIC - GALWAY
Product Code: LOX
PMA / PMN Number: P860019
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(6). (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, 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 A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. THE 90% STENOSED LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND CALCIFIED UNSPECIFIED CORONARY VESSEL. THE PHYSICIAN ADVANCED THE 15MM X 2.0MM MAVERICK 2 MONORAIL BALLOON CATHETER AND ATTEMPTED TO PREDILATE THE LESION. THE MAVERICK 2 BALLOON WAS INFLATED ONCE TO "NOMINAL PRESSURE" AND THE BALLOON RUPTURED. THE PHYSICIAN COMPLETED THE PROCEDURE WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MAVERICK2 BALLOON CATHETER	CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS	LOX	BOSTON SCIENTIFIC - GALWAY	H7493892815200	13562126

Patients

Seq	Age	Sex	Outcome	Treatment
1