FDA Adverse Event Malfunction Summary report: N

APEX¿

MDR report key: 3013017 · Received March 20, 2013

Report

Report Number: 2134265-2013-01570
Event Type: Malfunction
Date Received: March 20, 2013
Date of Event: February 20, 2013
Report Date: February 21, 2013
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

AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4). DEVICE EVALUATED BY MANUFACTURER: AS THE UNIT HAS NOT BEEN RETURNED A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

Description of Event or Problem · 1

SAME CASE AS MFR#: 2134265-2013-01571. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE A BALLOON RUPTURE OCCURRED. THE VASCULAR DIAMETER WAS LARGE. THE 75% STENOSED LESION WAS LOCATED IN A MILDLY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. A 4X20MM APEX BALLOON WAS INFLATED AND ON THE FIRST INFLATION RUPTURED AT EIGHT ATMOSPHERES. THE BALLOON WAS REMOVED INTACT. THEN A MAVERICK XL MR, 5.5MM X 15MM BALLOON WAS INFLATED AND ON THE FIST INFLATION RUPTURED AT SIX ATMOSPHERES. THE DEVICE WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED 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
115478	APEX¿	CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS	LOX	BOSTON SCIENTIFIC - GALWAY	H7493895920400	13916120

Patients

Seq	Age	Sex	Outcome	Treatment
1				GUIDE WIRE: RINATO (ASAHI INTECC)\| INFLATION DEVICE: ENCORE26