FDA Adverse Event Malfunction Summary report: N

MAVERICK¿ XL

MDR report key: 3013018 · Received March 20, 2013

Report

Report Number: 2134265-2013-01571
Event Type: Malfunction
Date Received: March 20, 2013
Date of Event: February 20, 2013
Report Date: February 21, 2013
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: LOX
PMA / PMN Number: P860019
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

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 #: 2134265-2013-01570. 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
116308	MAVERICK¿ XL	CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS	LOX	BOSTON SCIENTIFIC - MAPLE GROVE	H7493790955150	15271178

Patients

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