FDA Adverse Event Malfunction Summary report: N

MAVERICK2 BALLOON CATHETER

MDR report key: 2873047 · Received December 13, 2012

Report

Report Number: 2134265-2012-07532
Event Type: Malfunction
Date Received: December 13, 2012
Date of Event: November 15, 2012
Report Date: November 16, 2012
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: LOX
PMA / PMN Number: P860019
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). DEVICE EVALUATED BY MFR: 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 2134265-2012-07531. IT WAS REPORTED THAT DURING A STENTING INTERVENTION TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. THE 95% STENOTIC LESION WAS LOCATED IN THE MILDLY TORTUOUS AND MILDLY CALCIFIED MID RIGHT CORONARY ARTERY. THE PHYSICIAN ADVANCED A 2.0X12MM MAVERICK 2 BALLOON CATHETER TO THE LESION AND ON THE FIRST INFLATION, INFLATED THE BALLOON TO A NOMINAL PRESSURE FOR SEVENTEEN SECONDS AND THE BALLOON RUPTURED. THE GAUGE ON THE INFLATION UNIT READ 2ATMS AT THE TIME OF THE RUPTURE. THE BALLOON WAS REMOVED INTACT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS OK.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	MAVERICK2 BALLOON CATHETER	CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS	LOX	BOSTON SCIENTIFIC - MAPLE GROVE	UNK228

Patients

Seq	Age	Sex	Outcome	Treatment
1	63 YR			ADVANTAGE BALLOON CATHETER INFLATION DEVICE