ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014

Report

Report Number: 2939204-2010-01125
Event Type: Injury
Date Received: December 17, 2010
Date of Event: November 24, 2010
Report Date: November 25, 2010
Manufacturer: BOSTON SCIENTIFIC - FREMONT
Product Code: DQO
PMA / PMN Number: K063312
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED ON THE LOT AND NO ISSUES OR DISCREPANCIES WERE FOUND. THE CATHETER WAS RETURNED IN TWO PIECES. FIRST PIECE MEASURED 168.5CM LONG AND THE SECOND PIECE, THE BROKEN DISTAL TIP ASSEMBLY, MEASURED 2.4 CM LONG. VISUAL INSPECTION OF THE RETURNED CATHETER OBSERVED FLUID INSIDE OF THE TELESCOPE AND DISTAL TIP ASSEMBLY. NO FLUID WAS FOUND INSIDE THE HUB AND NO KINK WAS OBSERVED IN THE SHEATH ASSEMBLY. A KINK WAS OBSERVED IN THE BROKEN DISTAL TIP ASSEMBLY AND APPEARS TO BE UNRELATED TO THE TIP BREAK. OPERATIONAL CONTEXT IS THE LIKELY CAUSE FOR THE KINK. IMAGE CHARACTERIZATION TESTING REVEALED A GOOD SQUARE IMAGE APPEARED IN THE SYSTEM AND THE PRODUCT PERFORMED WITHIN SPECIFICATION. THE FRACTURE LOCATION WAS ANALYZED USING SEM (SCANNING ELECTRON MICROSCOPY). BASED ON RESULTS OF THE SEM ANALYSIS, THIS BREAK IS CLEAN AND ABRUPT WITH NO SIGNS OF ELONGATION. THIS BREAK IS CONSISTENT WITH PREVIOUS FAILURES OF THIS NATURE THAT HAD A HIGHER LEVEL OF CATHETER OXIDATION AND BRITTLENESS. A REVIEW OF THE DEVICE LABELING AND DIRECTIONS FOR USE (DFU) REVEALED THESE WARNINGS: NEVER ADVANCE OR WITHDRAW THE IMAGING CATHETER WITHOUT FLUOROSCOPIC VISUALIZATION BECAUSE IT MAY CAUSE VESSEL INJURY OR PATIENT COMPLICATIONS. DO NOT ADVANCE THE CATHETER IF RESISTANCE IS ENCOUNTERED. THE CATHETER SHOULD NEVER BE FORCIBLY INSERTED INTO LUMENS NARROWER THAN THE CATHETER BODY OR FORCED THROUGH A TIGHT STENOSIS. A CATHETER THAT IS FORCIBLY ADVANCED MAY CAUSE CATHETER DAMAGE RESULTING IN VESSEL INJURY OR PATIENT COMPLICATIONS. IF RESISTANCE IS MET UPON WITHDRAWAL OF THE CATHETER, VERIFY RESISTANCE USING FLUOROSCOPY, THEN REMOVE THE ENTIRE SYSTEM SIMULTANEOUSLY. A CATHETER THAT IS FORCIBLY REMOVED MAY CAUSE VESSEL INJURY OR PATIENT COMPLICATIONS. WHEN ADVANCING THE CATHETER THROUGH A STENTED VESSEL, CATHETERS THAT DO NOT COMPLETELY ENCAPSULATE THE GUIDEWIRE MAY ENGAGE THE STENT BETWEEN THE JUNCTION OF THE CATHETER AND GUIDEWIRE, RESULTING IN ENTRAPMENT OF CATHETER/GUIDEWIRE, CATHETER TIP SEPARATION, AND/OR STENT DISLOCATION. WHEN READVANCING A GUIDEWIRE AFTER DEPLOYMENT OF STENT(S), AT NO TIME SHOULD A CATHETER BE ADVANCED ACROSS A GUIDEWIRE THAT MAY BE PASSING BETWEEN ONE OR MORE STENT STRUTS. A GUIDEWIRE MAY EXIT BETWEEN ONE OR MORE STENT STRUTS WHEN RECROSSING STENT(S). SUBSEQUENT ADVANCEMENT OF THE CATHETER COULD CAUSE ENTANGLEMENT BETWEEN THE CATHETER AND THE STENT(S), RESULTING IN ENTRAPMENT OF CATHETER/GUIDEWIRE, CATHETER TIP SEPARATION AND/OR STENT DISLOCATION. USE CAUTION WHEN REMOVING THE CATHETER FROM A STENTED VESSEL. INADEQUATELY APPOSED STENTS, OVERLAPPING STENTS, AND/OR SMALL STENTED VESSELS WITH DISTAL ANGULATION MAY LEAD TO ENTRAPMENT OF THE CATHETER WITH THE STENT UPON RETRACTION. WHEN RETRACTING THE CATHETER, ENSURE THAT THE SHORT RAIL DISTAL TIP IS PARALLEL TO THE GUIDEWIRE. SEPARATION OR BENDING OF THE GUIDEWIRE MAY RESULT IN KINKING OF THE GUIDEWIRE, DAMAGE TO THE CATHETER DISTAL TIP, AND/OR VESSEL INJURY. THE LOOPED GUIDEWIRE OR DAMAGED TIP MAY CATCH ON THE STENT STRUT RESULTING IN ENTRAPMENT. THE REVIEW OF THE DEVICE LABELING FOUND NO EVIDENCE OR INDICATION THAT THE CATHETER WAS USED AGAINST THE LABELING AND/OR DIRECTIONS FOR USE. THE CAUSE OF THE FRAGILE TIP DETACHMENT HAS BEEN DETERMINED TO BE OXIDATION OF THE CATHETER WHICH CAUSES EMBRITTLEMENT INCREASING THE LIKELIHOOD OF TIP DETACHMENTS OF THIS NATURE. A ROOT CAUSE OF DESIGN WAS ASSIGNED.

Description of Event or Problem · 1

PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED IN A 75% STENOSED LESION WITH MODERATE CALCIFICATION IN THE DISTAL LEFT CIRCUMFLEX (LCX) ARTERY AND MODERATE TORTUOSITY IN THE OSTIUM OF THE LCX. THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS PREPPED WITHOUT INCIDENT AND USED FOR PRE-IVUS WITHOUT PROBLEM. A STENT WAS IMPLANTED AFTER PRE-DILATATION AND THE IVUS CATHETER WAS THEN USED TO IMAGE THE STENT PLACEMENT; PULLBACK WAS COMPLETED SUCCESSFULLY. THERE WAS NO RESISTANCE DURING REMOVAL OF THE IVUS CATHETER FROM THE PATIENT. THE PHYSICIAN NOTICED THE TIP OF THE IVUS CATHETER HAD DETACHED (RO MARKER WAS VISUALIZED) AND REMAINED IN THE IMPLANTED STENT LOCATION. THE DETACHED TIP WAS SUCCESSFULLY RETRIEVED WITH A SNARE. THE STENT WAS NOT DAMAGED. THE PROCEDURE WAS COMPLETED WITH A NEW IVUS CATHETER AND THE PATIENT STATUS WAS REPORTED AS 'GOOD'.

Description of Event or Problem · 1

PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED IN A 75% STENOSED LESION WITH MODERATE CALCIFICATION IN THE DISTAL LEFT CIRCUMFLEX (LCX) ARTERY AND MODERATE TORTUOSITY IN THE OSTIUM OF THE LCX. THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS PREPPED WITHOUT INCIDENT AND USED FOR PRE-IVUS WITHOUT PROBLEM. A STENT WAS IMPLANTED AFTER PRE-DILATATION AND THE IVUS CATHETER WAS THEN USED TO IMAGE THE STENT PLACEMENT; PULLBACK WAS COMPLETED SUCCESSFULLY. THERE WAS NO RESISTANCE DURING REMOVAL OF THE IVUS CATHETER FROM THE PATIENT. THE PHYSICIAN NOTICED THE TIP OF THE IVUS CATHETER HAD DETACHED (RO MARKER WAS VISUALIZED) AND REMAINED IN THE IMPLANTED STENT LOCATION. THE DETACHED TIP WAS SUCCESSFULLY RETRIEVED WITH A SNARE. THE STENT WAS NOT DAMAGED. THE PROCEDURE WAS COMPLETED WITH A NEW IVUS CATHETER AND THE PATIENT STATUS WAS REPORTED AS "GOOD".

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014	CATHETER, INTRAVASCULAR, DIAGNOSTIC	DQO	BOSTON SCIENTIFIC - FREMONT	H749390140	0013280986

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	ABBOTT XIENCE STENT