ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014
Report
- Report Number
- 2939204-2010-01152
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- December 2, 2010
- Report Date
- December 2, 2010
- Manufacturer
- BOSTON SCIENTIFIC - FREMONT
- Product Code
- DQO
- PMA / PMN Number
- K063312
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
(B)(4) - NEW CODE REQUEST HAS BEEN SUBMITTED FOR STUCK IN SENT.
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 THIS LOT. THE MALE/FEMALE LUER WAS DISCONNECTED AND THE IMAGING CORE WAS OUTSIDE OF THE SHEATH ASSEMBLY AND WAS UNABLE TO REINSERT BACK INTO THE SHEATH WHEN RECEIVED. A KINK WAS OBSERVED IN THE SHEATH ASSEMBLY; IT WAS BELIEVED THAT THE LUER DISCONNECT AND KINK OCCURRED IN ATTEMPTS TO FREE THE DEVICE. NO DAMAGE WAS OBSERVED ON THE GUIDEWIRE EXIT PORT. A TEST GUIDEWIRE (0.014") WAS INSERTED AND NO INDICATION OF RESISTANCE IN TRACKING THE GUIDEWIRE INTO THE CATHETER WAS NOTED. DURING IMAGE CHARACTERIZATION TESTING, NO IMAGE APPEARED IN THE SYSTEM DUE TO ELECTRICAL OPEN AT DISTAL, WHICH IS UNRELATED TO THE REPORTED STUCK IN STENT EVENT. A REVIEW OF 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. 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.
A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). DURING THE SECOND PULL BACK, IT WAS REPORTED THAT THE INTRAVASCULAR ULTRASOUND (IVUS) CATHETER "GOT STUCK ON THE STENT FOR A WHILE". THE LOCATION WHERE THE CATHETER WAS STUCK ON THE STENT AND THE METHOD(S) THE PHYSICIAN USED TO RELEASE THE DEVICE ARE UNKNOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE WITH NO PATIENT COMPLICATIONS REPORTED. THE PATIENT'S CONDITION WAS REPORTED AS "GOOD".
A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS BEING USED TO VISUALIZE STENT PLACEMENT, WHICH WAS FOUND TO BE FULLY DILATED. WHILE PERFORMING THE SECOND PULL BACK, IT WAS REPORTED THAT THE CATHETER "GOT STUCK ON THE STENT FOR A WHILE." THE PHYSICIAN WAS ABLE TO RELEASE THE CATHETER FROM THE STENT STRUT BY TORQUING THE CATHETER. FOLLOW-UP WAS UNABLE TO DETERMINE HOW LONG THE CATHETER WAS "STUCK" ON THE STENT; HOWEVER, IT WAS REPORTED THAT THERE WAS NO PATIENT COMPLICATIONS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION WAS REPORTED AS "GOOD."
A PERCUTANEOUS CORONARY INTERVENTION (PCI) WAS PERFORMED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). AN INTRAVASCULAR ULTRASOUND (IVUS) CATHETER WAS BEING USED TO VISUALIZE STENT PLACEMENT, WHICH WAS FOUND TO BE FULLY DILATED. WHILE PERFORMING THE SECOND PULL BACK, IT WAS REPORTED THAT THE CATHETER "GOT STUCK ON THE STENT FOR A WHILE." THE PHYSICIAN WAS ABLE TO RELEASE THE CATHETER FROM THE STENT STRUT BY TORQUING THE CATHETER. FOLLOW-UP WAS UNABLE TO DETERMINE HOW LONG THE CATHETER WAS "STUCK" ON THE STENT; HOWEVER, IT WAS REPORTED THAT THERE WAS NO PATIENT COMPLICATIONS. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER OF THE SAME DEVICE. THE PATIENT'S CONDITION 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 | 13773184 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | TAXUS LIBERTE STENT |