| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 3D | NLI | STRYKER SUSTAINABILITY SOLUTIONS PHOENIX | OWQ | SNDSTR10 | SNDSTR10CO | UNKNOWN | R | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-01-28 | 0 | 1. R |
Patient 1
IT WAS REPORTED, "THE DEVICE PERFORATED THE RIGHT VENTRICLE BECAUSE OF DIFFICULTY IN STEERING." PROCEDURE WAS SUSPENDED AFTER THE PERFORATION. TWO TAPS WERE DONE TO REMOVE FLUID, BUT THIS WAS UNSUCCESSFUL, THE PATIENT CODED AND WAS THEN TAKEN INTO THE OPERATING ROOM TO REPAIR THE PERFORATION.
Patient 1
THE COMPLAINT DEVICE WAS NOT RETURNED TO STRYKER SUSTAINABILITY SOLUTIONS (SSS) FOR AN EVALUATION. STRYKER SUSTAINABILITY SOLUTIONS' INSTRUCTIONS FOR USE (IFU) STATE: DO NOT EXERT EXCESSIVE PRESSURE DURING PLACEMENT OF CATHETER IF UNKNOWN RESISTANCE IS ENCOUNTERED. VASCULAR DAMAGE, INCLUDING PERFORATION, IS A SMALL BUT INHERENT RISK. CAREFULLY MANIPULATE THE CATHETER IN ORDER TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. IF ENCOUNTERING STRONG RESISTANCE DURING CATHETER ARTICULATION, DISCONTINUE THE PROCEDURE AND DETERMINE THE CAUSE OF THE RESISTANCE BEFORE PROCEEDING. INSPECT THE CATHETER FOR OVERALL CONDITION AND PHYSICAL INTEGRITY. DO NOT USE THE CATHETER IF ANY DAMAGE IS NOTED. IF SUCH PROBLEMS EXIST, RETURN THE CATHETER AND PACKAGING TO STRYKER SUSTAINABILITY SOLUTIONS. ROTATE THE STEERING CONTROL KNOBS. THE FUNCTION SHOULD BE SMOOTH AND THE CATHETER TIP SHOULD FLEX IN A CORRESPONDING DIRECTION UP TO 160?. THE TENSION CONTROL KNOB IS COMPLETELY RELEASED BY ROTATING FULLY COUNTER CLOCKWISE. FOR PROPER CARE AND HANDLING OF THE ULTRASOUND CATHETER, ALWAYS HOLD THE ULTRASOUND CATHETER BY THE HANDLE AND SUPPORT THE CATHETER SHAFT. AVOID TOUCHING THE ULTRASOUND CATHETER INTERCONNECT TAB. AVOID EXCESSIVE KINKING OR BENDING OF CATHETER, AS THIS MAY INTERFERE WITH DISTAL TIP SHAPING. SINCE THE DEVICE WAS NOT RETURNED FOR AN EVALUATION A ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER, SOME POTENTIAL ROOT CAUSES COULD BE: IMPROPER CURVE AS A RESULT OF MISHANDLING PRIOR/SUBSEQUENT TO DISTRIBUTION FROM STRYKER (INCLUDES USER STORAGE METHODS). ARTICULATION WIRE FAILURE/FATIGUE AS A RESULT OF MISHANDLING PRIOR/SUBSEQUENT TO DISTRIBUTION FROM STRYKER (INCLUDES USER STORAGE METHODS). USER ERROR (INCLUDES USER TECHNIQUE AND METHODS). USER EXPECTATION OF THE ANTICIPATED ARTICULATION CONFIGURATION. ANCILLARY EQUIPMENT ERROR (INCLUDES ALL OTHER EQUIPMENT OUTSIDE OF THE COMPLAINT DEVICE THAT MAY HAVE CONTRIBUTED TO THE ERROR). THE REPORTED EVENT IS NOT OCCURRING MORE FREQUENTLY OR WITH GREATER SEVERITY THAN IS USUAL FOR THE DEVICE.