ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014
Report
- Report Number
- 2939204-2011-00052
- Event Type
- Injury
- Date Received
- February 7, 2011
- Date of Event
- January 26, 2011
- Report Date
- January 26, 2011
- Manufacturer
- BOSTON SCIENTIFIC - FREMONT
- Product Code
- DQO
- PMA / PMN Number
- K063312
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4) - STUCK IN STENT.
A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED ON THE LOT AND NO ISSUES OR DISCREPANCIES WERE FOUND. INSPECTION OF THE RETURNED CATHETER REVEALED THE HUB, IMAGING CORE, TELESCOPE AND THE PROXIMAL PORTION OF THE SHEATH ASSEMBLY WERE MISSING AND APPEARED TO HAVE BEEN CUT FROM THE CATHETER, LIKELY AS A RESULT OF THE EFFORTS TO REMOVE THE CATHETER. THE SECTION OF THE SHEATH ASSEMBLY THAT WAS RECEIVED MEASURED 137.0 CM LONG. VISUAL INSPECTION OF THE CATHETER REVEALED FLUID INSIDE OF THE DISTAL TIP ASSEMBLY AND TELESCOPE ASSEMBLY. NO KINK WAS OBSERVED IN THE SHEATH ASSEMBLY. THE GUIDEWIRE EXIT PORT WAS LIFTED AND RIPPED. A TEST GUIDEWIRE WAS INSERTED AND COULD NOT GO THROUGH THE GUIDEWIRE EXIT PORT DUE TO DRY BLOOD IN THE DISTAL TIP ASSEMBLY. THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE BROKEN AND MISSING PARTS OF THE CATHETER. 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. BASED ON THE EVENT DESCRIPTION, THE OBSERVED CONDITION OF THE RETURNED DEVICE, DFU REVIEW AND THE ANATOMICAL AND PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE, THE CAUSE OF THE STUCK IN STENT HAS BEEN DETERMINED TO BE DUE TO OPERATIONAL CONTEXT.
PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED IN A 75% STENOSED LESION WITHOUT CALCIFICATION AND MODERATE TORTUOSITY IN THE LEFT CIRCUMFLEX (LCX) PROXIMAL AND LCX OBTUSE MARGINAL. THE LESION WAS PRE-DILATED WITH A 2.5 MM BALLOON CATHETER AND THEN A STENT WAS IMPLANTED IN THE LESION. KISSING BALLOON TECHNIQUE WAS PERFORMED WITH A 3.0 MM BALLOON FOR THE LCX PROXIMAL AND LCX OBTUSE MARGINAL. INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS USED TO VIEW STENT PLACEMENT. IT WAS NOTED THAT THE DISTAL PORTION OF THE STENT IN THE LCX OBTUSE MARGINAL WAS NOT EXPANDED WELL. THE STENT WAS POST-DILATED WITH A DIFFERENT 2.5 MM BALLOON CATHETER AND IVUS WAS PERFORMED AGAIN. WHILE WITHDRAWING THE IVUS CATHETER, THE PHYSICIAN FELT RESISTANCE; THE GUIDEWIRE EXIT PORT OF THE IVUS CATHETER HAD BECAME STUCK WITH THE STENT. THE PHYSICIAN REMOVED THE IMAGING CORE FROM THE IVUS CATHETER, LOADED ANOTHER GUIDE CATHETER ONTO THE IVUS SHEATH AND ADVANCED IT TO THE STUCK LOCATION. THE IVUS CATHETER WAS RELEASED FROM THE STENT AND SUCCESSFULLY REMOVED FROM THE PATIENT. THE PATIENT STATUS WAS REPORTED AS "GOOD".
PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED IN A 75% STENOSED LESION WITHOUT CALCIFICATION AND MODERATE TORTUOSITY IN THE LEFT CIRCUMFLEX (LCX) PROXIMAL AND LCX OBTUSE MARGINAL. THE LESION WAS PRE-DILATED WITH A 2.5 MM BALLOON CATHETER AND THEN A STENT WAS IMPLANTED IN THE LESION. KISSING BALLOON TECHNIQUE WAS PERFORMED WITH A 3.0 MM BALLOON FOR THE LCX PROXIMAL AND LCX OBTUSE MARGINAL. INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS USED TO VIEW STENT PLACEMENT. IT WAS NOTED THAT THE DISTAL PORTION OF THE STENT IN THE LCX OBTUSE MARGINAL WAS NOT EXPANDED WELL. THE STENT WAS POST-DILATED WITH A DIFFERENT 2.5 MM BALLOON CATHETER AND IVUS WAS PERFORMED AGAIN. WHILE WITHDRAWING THE IVUS CATHETER, THE PHYSICIAN FELT RESISTANCE; THE GUIDEWIRE EXIT PORT OF THE IVUS CATHETER HAD BECAME STUCK WITH THE STENT. THE PHYSICIAN REMOVED THE IMAGING CORE FROM THE IVUS CATHETER, LOADED ANOTHER GUIDE CATHETER ONTO THE IVUS SHEATH AND ADVANCED IT TO THE STUCK LOCATION. THE IVUS CATHETER WAS RELEASED FROM THE STENT AND SUCCESSFULLY REMOVED FROM THE PATIENT. 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 | 13960914 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | ABBOTT NC VOYAGER 2.5MM BALLOON CATHETER| ABBOTT BALANCE GUIDE WIRE| BSC 6 FR MACH1 VL3 GUIDE CATHETER| BIOSENSORS S-STENT 3.0X15MM| TERUMO TAZUNA 2.5MM AND 3.0MM BALLOON CATHETERS |