ICROSS 40 MHZ CORONARY IMAGING CATHETER
Report
- Report Number
- 2939204-2011-00014
- Event Type
- Malfunction
- Date Received
- January 28, 2011
- Date of Event
- November 29, 2010
- Report Date
- January 6, 2011
- Manufacturer
- BOSTON SCIENTIFIC - FREMONT
- Product Code
- DQO
- PMA / PMN Number
- K063312
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED ON THE LOT AND NOTHING RELEVANT TO THE EVENT WAS FOUND. NO LOT SPECIFIC ISSUES WERE FOUND IN SIMILAR COMPLAINTS REVIEW. VISUAL INSPECTION OF THE RETURNED CATHETER REVEALED THE SHEATH ASSEMBLY WAS BROKEN OFF AND THE IMAGING CORE WAS EXPOSED AND APPEARED TWISTED AND STRETCHED. THE SEPARATION SITE WAS EXAMINED AND SHOWS INDICATIONS THAT THE SHEATH WAS CUT, WHICH MAY HAVE EXPOSED THE IMAGING CORE, RESULTING IN THE TWISTED AND STRETCHED IMAGING CORE. THE CUT WAS NOT BRITTLE OR JAGGED. FLUID WAS OBSERVED INSIDE THE TELESCOPE AND DISTAL TIP ASSEMBLY. NO FLUID WAS FOUND INSIDE THE HUB. KINKS WERE OBSERVED IN THE SHEATH ASSEMBLY AND IMAGING WINDOW LIKELY RESULTING FROM OPERATIONAL CONTEXT. ONE HUB WING WAS BENT LIKELY RESULTING FROM HANDLING DAMAGE. IMAGING CORE WIND UP IN THE TELESCOPE ASSEMBLY WAS OBSERVED. WIND UP, A DESIGN ISSUE, IS A RESULT OF THE IMAGING CORE BEING CONSTRAINED WHICH BREAKS THE SIGNAL PATHWAY LEADING IMAGE ISSUES. THE OBSERVED KINKS, BENT HUB WING AND WINDUP ARE UNRELATED TO THE SHEATH SEPARATION. THE DEVICE LABELING AND DIRECTIONS FOR USE (DFU) REVEALED THESE WARNINGS: "DO NOT PINCH, CRUSH, KINK OR SHARPLY BEND THE CATHETER AT ANY TIME. THIS CAN CAUSE POOR CATHETER PERFORMANCE, VESSEL INJURY OR PATIENT COMPLICATIONS. AN INSERTION ANGLE GREATER THAN 45 DEGREES IS CONSIDERED EXCESSIVE. 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. BASED ON THE OBSERVED DAMAGE TO THE SHEATH WHICH INDICATES THE SHEATH WAS CUT, A ROOT CAUSE OF UNDETERMINABLE HAS BEEN ASSIGNED.
THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS BEING USED TO IMAGE A 95% STENOSED LESION WITH HIGH CALCIFICATION AND HIGH TORTUOSITY IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WHEN THE PHYSICIAN WAS NOTED THAT THE MARKER BANDS DID NOT APPEAR TO BE IN THEIR TYPICAL LOCATIONS. THE IVUS CATHETER WAS REMOVED WITHOUT RESISTANCE AND A SECOND IVUS CATHETER WAS USED SUCCESSFULLY. THE PATIENT STATUS WAS REPORTED AS "FINE". UPON INSPECTION OF THE RETURNED DEVICE BY THE MANUFACTURER, IT WAS NOTED THAT THE SHEATH ASSEMBLY WAS BROKEN OFF APPROXIMATELY 71.2 CM FROM THE FEMORAL MARKER ON THE DISTAL SIDE. THE USER HAD NOT INDICATED THEY HAD EXPERIENCED OR OBSERVED ANY BREAKAGE OF THE IVUS CATHETER DURING USE. IT IS UNKNOWN WHEN AND HOW THE BREAK OCCURRED; HOWEVER, BASED ON THE CONDITION OF THE RETURNED IVUS CATHETER, THE MANUFACTURER IS REPORTING A MALFUNCTION FOR THE OBSERVED SHEATH ASSEMBLY BREAK.
THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS BEING USED TO IMAGE A 95% STENOSED LESION WITH HIGH CALCIFICATION AND HIGH TORTUOSITY IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WHEN THE PHYSICIAN WAS NOTED THAT THE MARKER BANDS DID NOT APPEAR TO BE IN THEIR TYPICAL LOCATIONS. THE IVUS CATHETER WAS REMOVED WITHOUT RESISTANCE AND A SECOND IVUS CATHETER WAS USED SUCCESSFULLY. THE PATIENT STATUS WAS REPORTED AS 'FINE'. UPON INSPECTION OF THE RETURNED DEVICE BY THE MANUFACTURER, IT WAS NOTED THAT THE SHEATH ASSEMBLY WAS BROKEN OFF APPROXIMATELY 71.2 CM FROM THE FEMORAL MARKER ON THE DISTAL SIDE. THE USER HAD NOT INDICATED THEY HAD EXPERIENCED OR OBSERVED ANY BREAKAGE OF THE IVUS CATHETER DURING USE. IT IS UNKNOWN WHEN AND HOW THE BREAK OCCURRED; HOWEVER, BASED ON THE CONDITION OF THE RETURNED IVUS CATHETER, THE MANUFACTURER IS REPORTING A MALFUNCTION FOR THE OBSERVED SHEATH ASSEMBLY BREAK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ICROSS 40 MHZ CORONARY IMAGING CATHETER | CATHETER, INTRAVASCULAR, DIAGNOSTIC | DQO | BOSTON SCIENTIFIC - FREMONT | H749518050 | 13550071 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | BSC 6F RUNWAY CLS 3.5 GUIDE CATHETER |