FDA Adverse Event Malfunction Summary report: N

QUANTUM MAVERICK BALLOON CATHETER

MDR report key: 1833525 · Received September 14, 2010

Report

Report Number: 2134265-2010-04038
Event Type: Malfunction
Date Received: September 14, 2010
Date of Event: April 12, 2010
Report Date: August 23, 2010
Product Code: LOX
PMA / PMN Number: P860019
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AR, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4). DEVICE EVALUATION 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 MFG. # 2134265-2010-04036, 2134265-2010-04037, 2134265-2010-04039, AND 2134265-2010-04040. IT WAS REPORTED THAT DURING A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) PROCEDURE, 4 BALLOON RUPTURES OCCURRED. THE LESION WAS LOCATED IN THE CALCIFIED RIGHT CORONARY ARTERY (RCA). LESION DETAILS ARE UNKNOWN. AN APEX BALLOON 20X3.0MM, A QUANTUM MAVERICK 12X4.0MM, A QUANTUM MAVERICK 15X4.0, AND 2 QUANTUM MAVERICK 20X4.0 BALLOONS WERE ADVANCED TO THE LESION AND INFLATED "BETWEEN 16-22 ATM" AND RUPTURED. THE INFLATION DETAILS ARE UNKNOWN. THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS FINE. FURTHER INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	QUANTUM MAVERICK BALLOON CATHETER	CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS	LOX		H7493808015400

Patients

Seq	Age	Sex	Outcome	Treatment
1	46 YR