FDA Adverse Event Malfunction Summary report: N

QUANTUM MAVERICK BALLOON CATHETER

MDR report key: 1833847 · Received September 14, 2010

Report

Report Number: 2134265-2010-04030
Event Type: Malfunction
Date Received: September 14, 2010
Date of Event: August 25, 2010
Report Date: August 26, 2010
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

(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. THE 90% STENOSED LESION WAS LOCATED IN A MODERATELY TORTUOUS 1ST DIAGONAL BRANCH. THE 2.5X15 QUANTUM MAVERICK MONORAIL BALLOON WAS BEING USE FOR POST DILATATION. THE BALLOON RUPTURED AT FOURTEEN ATMOSPHERES. IT IS UNKNOWN HOW MANY INFLATIONS OCCURRED. 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	QUANTUM MAVERICK BALLOON CATHETER	CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS	LOX	BOSTON SCIENTIFIC - MAPLE GROVE	H7493808015250	0013421548

Patients

Seq	Age	Sex	Outcome	Treatment
1