NC QUANTUM APEX?

Report

Report Number: 2134265-2014-04558
Event Type: Malfunction
Date Received: August 5, 2014
Date of Event: July 9, 2014
Report Date: July 9, 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

DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A NC QUANTUM APEX BALLOON CATHETER. THERE WAS CONTRAST AND BLOOD IN THE INFLATION LUMEN AND BALLOON AND BLOOD IN THE GUIDEWIRE LUMEN. THE BALLOON WAS LOOSELY FOLDED. INSPECTION OF THE DEVICE PRESENTED NO DAMAGE OR IRREGULARITIES. MICROSCOPIC EXAMINATION OF THE BALLOON AND SHAFT DID NOT REVEAL ANY TEARS OR DAMAGE. THE DEVICE WAS PREPPED WITH AN INFLATION DEVICE FILLED WITH WATER AND CONNECTED TO THE INFLATION PORT TO INFLATE THE DEVICE TO RATED BURST PRESSURE FOR 5 MINUTES. THE CATHETER MAINTAINED CONSTANT PRESSURE AND THERE WAS NO INDICATION OF ANY LEAKS OR OTHER IRREGULARITIES. THE INNER DIAMETER (ID) OF THE CATHETER WAS MEASURED AT EXIT NOTCH AND DISTAL TIP; AND IS WITHIN THE NC QUANTUM APEX SPECIFICATIONS. THE GUIDEWIRE USED IN THE PROCEDURE WAS NOT RECEIVED WITH THIS DEVICE. A FORTE GUIDEWIRE WAS USED FOR FUNCTIONAL TESTING. THE OUTER DIAMETER (OD) OF THE FORTE GUIDEWIRE WAS MEASURED. FUNCTIONAL TESTING WAS PERFORMED BY LOADING THE GUIDEWIRE INTO THE TIP AND EXIT NOTCH. THE GUIDEWIRE WAS ABLE TO BE ADVANCED THROUGH THE ENTIRE LENGTH OF THE INNER SHAFT BOTH TIMES NO RESISTANCE. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES CONTRIBUTING TO THE REPORTED CATHETER FROZE ON THE GUIDEWIRE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE ROOT CAUSE IS NOT CONFIRMED AS THERE WAS NO EVIDENCE OF THE ALLEGED ISSUE OR ANY ANOMALIES WHICH COULD HAVE CONTRIBUTED TO THE REPORTED DIFFICULTY. (B)(4).

Additional Manufacturer Narrative · 1

AGE AT TIME OF EVENT: 18 YEARS OR OLDER. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. AN 8MM X 3.00MM NC QUANTUM APEX¿ BALLOON CATHETER WAS ADVANCED FOR POST DILATION OF AN UNSPECIFIED STENT. WHEN THE BALLOON WAS INFLATED AT 20 ATMOSPHERES, IT BECAME STUCK ON A NON BSC GUIDE WIRE AND WAS UNABLE TO BE REMOVED, SO THE BALLOON CATHETER AND THE GUIDE WIRE WERE REMOVED TOGETHER. IT WAS SUSPECTED THAT THIS ISSUE MIGHT HAVE BEEN ATTRIBUTED TO THE GUIDE WIRE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS GOOD.

Description of Event or Problem · 1

IT WAS REPORTED THAT CATHETER ENTRAPMENT OCCURRED. THE 90% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY CALCIFIED AND MODERATELY TORTUOUS MID LEFT ANTERIOR DESCENDING ARTERY. AN 8MM X 3.00MM NC QUANTUM APEX¿ BALLOON CATHETER WAS ADVANCED FOR POST DILATION OF AN UNSPECIFIED STENT. WHEN THE BALLOON WAS INFLATED AT 20 ATMOSPHERES, IT BECAME STUCK ON A NON BSC GUIDE WIRE AND WAS UNABLE TO BE REMOVED, SO THE BALLOON CATHETER AND THE GUIDE WIRE WERE REMOVED TOGETHER. IT WAS SUSPECTED THAT THIS ISSUE MIGHT HAVE BEEN ATTRIBUTED TO THE GUIDE WIRE. 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
456758	NC QUANTUM APEX?	CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS	LOX	BOSTON SCIENTIFIC - MAPLE GROVE	H7493912408300	16760911

Patients

Seq	Age	Sex	Outcome	Treatment
1				GUIDE WIRE: SION BLUE/ASAHI INTECC