FDA Adverse Event Malfunction Summary report: N

APEX MONORAIL

MDR report key: 1923755 · Received December 14, 2010

Report

Report Number: 2134265-2010-05493
Event Type: Malfunction
Date Received: December 14, 2010
Date of Event: November 25, 2010
Report Date: November 25, 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). 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 A PERCUTANEOUS CORONARY INTERVENTION PROCEDURE A BALLOON RUPTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL ARTERY. THE 99% STENOSED LESION WAS LOCATED IN THE CALCIFIED RIGHT CORONARY ARTERY (RCA). A 30MM X 2.00MM APEX MONORAIL BALLOON CATHETER WAS ADVANCED FOR PRE DILATION, AND ON THE FIRST INFLATION TO 14ATMS A BALLOON RUPTURE OCCURRED. THE BALLOON WAS REMOVED INTACT AND THE PROCEDURE WAS COMPLETED 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	APEX MONORAIL	CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS	LOX	BOSTON SCIENTIFIC - GALWAY	H7493895930200	0013295253

Patients

Seq	Age	Sex	Outcome	Treatment
1				GUIDE CATHETER, ASAHI INTEC\| GUIDE WIRE, RUNTHROUGH