FDA Adverse Event Malfunction Summary report: N

NC QUANTUM APEX?

MDR report key: 3925304 · Received July 10, 2014

Report

Report Number: 2134265-2014-03955
Event Type: Malfunction
Date Received: July 10, 2014
Date of Event: June 12, 2014
Report Date: June 12, 2014
Manufacturer: BOSTON SCIENTIFIC - MAPLE GROVE
Product Code: LOX
PMA / PMN Number: K121667
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

AGE AT TIME OF EVENT: 18 YEARS OR OLDER. DEVICE EVALUATED BY MFR.; THE COMPLAINT DEVICE WAS NOT RECEIVED AT THE COMPLAINT INVESTIGATION SITE (CIS) FOR ANALYSIS. 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

IT WAS REPORTED THAT A BALLOON RUPTURE OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS RIGHT CORONARY ARTERY. A 12MM X 3.75MM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED TO DILATE THE LESION. POST DILATATION WAS PERFORMED USING A NON BSC PRODUCT AFTER DEPLOYING A NON BSC PRODUCT ALSO. THE BALLOON WAS INFLATED FIRST AT 12 ATMOSPHERES AND ON THE SECOND INFLATION AT 16 ATMOSPHERES, THE BALLOON RUPTURED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
403071	NC QUANTUM APEX?	CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS	LOX	BOSTON SCIENTIFIC - MAPLE GROVE	H7493912412370	16756305

Patients

Seq	Age	Sex	Outcome	Treatment
1				GUIDEWIRE: SION BLUE\| GUIDING CATHETER: TERUMO 6F AL1\| BALLOON CATHETER: HIRYUPLUS3.75/15\| STENT: XIENCE3.5/18