NC QUANTUM APEX?

Report

Report Number: 2134265-2014-03916
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: SIMILAR
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A COYOTE NC BALLOON CATHETER. THERE WAS CONTRAST IN THE INFLATION LUMEN AND BALLOON. THE BALLOON WAS LOOSELY FOLDED. THE INNER SHAFT WAS BUCKLED 2.5MM ¿ 4MM DISTAL OF THE BI-COMPONENT WELD. THERE WAS A HOLE IN THE INNER SHAFT 2.5MM DISTAL OF THE BI-COMPONENT WELD. THE DIAMETER OF THE HOLE WAS SLIGHTLY LARGER THAN THE OUTER DIAMETER (OD) OF THE PROXIMAL END OF A GUIDEWIRE AND MAY BE CONSISTENT WITH PERFORATION OF THE SHAFT WALL WITH THE END OF A GUIDEWIRE DURING CLINICAL USE OR PREPARATION FOR CLINICAL USE. THE OUTER SHAFT WAS DAMAGED 0.5MM PROXIMAL OF THE BI-COMPONENT WELD. THE SHAFT WAS KINKED 5MM DISTAL OF THE BI-COMPONENT WELD. INSPECTION OF THE REMAINDER OF THE DEVICE PRESENTED NO OTHER DAMAGE OR IRREGULARITIES. THE INNER DIAMETER (ID) OF THE CATHETER WAS MEASURED AT BOTH ENDS AND IS WITHIN THE COYOTE NC 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 BOTH THE TIP AND EXIT NOTCH OF THE CATHETER AND ADVANCING THROUGH THE WIRE LUMEN; HOWEVER, RESISTANCE WAS ENCOUNTERED BOTH TIMES AT THE BUCKLED INNER SHAFT AND HOLE. THE GUIDEWIRE ADVANCED THROUGH HOLE BUT WOULD NOT ADVANCE PAST THE LOCATION OF BUCKLED INNER SHAFT. THE GUIDEWIRE WAS NOT STUCK IN THE LUMEN OF THE CATHETER AS REPORTED, BUT THE DAMAGED AND DIFFICULTIES LOADING THE GUIDEWIRE ARE CONSISTENT WITH THE REPORTED EVENT. THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES. 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).

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 ON GUIDE WIRE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS SUPERFICIAL FEMORAL ARTERY. AFTER A NON BSC GUIDE WIRE CROSSED THE LESION, A 5.0MMX20MMX143CM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED HOWEVER, THE GUIDE WIRE BECAME STUCK WITH THE BALLOON CATHETER. THE BALLOON CATHETER WAS REMOVED TOGETHER WITH THE WIRE AS A SINGLE UNIT AND NO DAMAGE WAS NOTED IN THE BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH A 5X22 STERLING BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD.

Description of Event or Problem · 1

IT WAS REPORTED THAT CATHETER ENTRAPMENT ON GUIDE WIRE OCCURRED. THE 99% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY CALCIFIED AND SEVERELY TORTUOUS SUPERFICIAL FEMORAL ARTERY. AFTER A NON BSC GUIDE WIRE CROSSED THE LESION, A 5.0MMX20MMX143CM NC QUANTUM APEX BALLOON CATHETER WAS ADVANCED HOWEVER, THE GUIDE WIRE BECAME STUCK WITH THE BALLOON CATHETER. THE BALLOON CATHETER WAS REMOVED TOGETHER WITH THE WIRE AS A SINGLE UNIT AND NO DAMAGE WAS NOTED IN THE BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH A 5X22 STERLING BALLOON CATHETER. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT¿S STATUS IS GOOD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
403134	NC QUANTUM APEX?	CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS	LOX	BOSTON SCIENTIFIC - MAPLE GROVE	H74939282502010	16879715

Patients

Seq	Age	Sex	Outcome	Treatment
1				GUIDE WIRE: TERUMO(FMD) NEBIDO