ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014
Report
- Report Number
- 2939204-2011-00215
- Event Type
- Malfunction
- Date Received
- April 18, 2011
- Date of Event
- April 1, 2011
- Report Date
- April 1, 2011
- Manufacturer
- BOSTON SCIENTIFIC - FREMONT
- Product Code
- DQO
- PMA / PMN Number
- K063312
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
CUSTOMER NOTIFICATION HAS BEEN DISTRIBUTED TO JAPANESE CUSTOMERS AND SENT TO THE PMDA. FDA REPORT OF CORRECTION AND REMOVAL WAS FILED (B)(4) 2011 (REFERENCE # 9912058-3/3/14/2011-0001-C). ADD'L MFR. NARRATIVE: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED ON THE LOT AND NO ISSUES OR DISCREPANCIES WERE FOUND. NO SIMILAR COMPLAINTS WERE FOUND IN THE LOT. THE CATHETER WAS RETURNED IN TWO PIECES. FIRST PIECE, THE DISTAL TIP END, MEASURED 2.5CM LONG AND THE REST OF THE CATHETER MEASURED 167.8CM 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. IMAGING CORE WIND UP IN THE TELESCOPE ASSEMBLY WAS OBSERVED AND APPEARS TO BE UNRELATED TO THE TIP BREAK. WIND UP, A DESIGN ISSUE, IS A RESULT OF THE IMAGING CORE BEING CONSTRAINED WHICH BREAKS THE SIGNAL PATHWAY LEADING TO IMAGE ISSUES. A SAMPLE OF THE DEVICE WAS SENT TO AN OUTSIDE VENDOR FOR OXIDATION ANALYSIS. BASED ON THE INFORMATION GATHERED, HIGH LEVELS OF OXIDATION AT THE SURFACE AND THROUGHOUT THE TESTED SAMPLE WERE NOTED. THE DEVICE LABELING AND DIRECTIONS FOR USE (DFU) CONTAINS 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 TIP DETACHMENT HAS BEEN DETERMINED TO BE OXIDATION OF THE CATHETER WHICH CAUSES EMBRITTLEMENT, INCREASING THE LIKELIHOOD OF TIP DETACHMENTS OF THIS NATURE. A PROBABLE ROOT CAUSE OF DESIGN WAS ASSIGNED.
A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON A 75% STENOSED, NON-CALCIFIED, MODERATELY TORTUOUS LESION LOCATED IN THE LEFT CIRCUMFLEX (LCX) OBTUSE MARGINAL. DURING INITIAL INSERTION OF THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER INTO THE PATIENT, THE CATHETER WAS UNABLE TO CROSS THE LESION. THE LESION WAS PRE-DILATED. THE IVUS CATHETER WAS ADVANCED INTO THE LESION AGAIN AND THE IMAGING RUN WAS COMPLETED WITHOUT INCIDENT. THE CATHETER WAS REMOVED FROM THE PATIENT ANATOMY WHEN THE PHYSICIAN OBSERVED THE DISTAL TIP HAD BECOME DETACHED; THE TIP WAS LOCATED INSIDE THE Y-CONNECTOR (OUTSIDE THE PATIENT'S ANATOMY). REPORTEDLY THERE WAS NO RESISTANCE MET DURING THE REMOVAL OF THE IVUS. THE PROCEDURE WAS COMPLETED WITH ANOTHER IVUS CATHETER. THE PATIENT'S CURRENT CONDITION IS REPORTED TO BE "FINE."
A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED ON A 75% STENOSED, NON-CALCIFIED, MODERATELY TORTUOUS LESION LOCATED IN THE LEFT CIRCUMFLEX (LCX) OBTUSE MARGINAL. DURING INITIAL INSERTION OF THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER INTO THE PATIENT, THE CATHETER WAS UNABLE TO CROSS THE LESION. THE LESION WAS PRE-DILATED. THE IVUS CATHETER WAS ADVANCED INTO THE LESION AGAIN AND THE IMAGING RUN WAS COMPLETED WITHOUT INCIDENT. THE CATHETER WAS REMOVED FROM THE PATIENT ANATOMY WHEN THE PHYSICIAN OBSERVED THE DISTAL TIP HAD BECOME DETACHED; THE TIP WAS LOCATED INSIDE THE Y-CONNECTOR (OUTSIDE THE PATIENT'S ANATOMY). REPORTEDLY THERE WAS NO RESISTANCE MET DURING THE REMOVAL OF THE IVUS. THE PROCEDURE WAS COMPLETED WITH ANOTHER IVUS CATHETER. THE PATIENT'S CURRENT CONDITION IS REPORTED TO BE "FINE".
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 | 13385941 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | BALLOON SYSTEM: TREK 2.5 X 15 MM, ABBOTT| GUIDEWIRE: 0.014" RUNTHROUGH EXTRA FLOPPY, TERUMO| GUIDE CATHETER: 6FR HEARTRAIL JL 4.0, TERUMO |