ATLANTIS¿ SR PRO²
Report
- Report Number
- 2134265-2013-02196
- Event Type
- Malfunction
- Date Received
- April 9, 2013
- Date of Event
- March 8, 2013
- Report Date
- March 11, 2013
- Manufacturer
- BOSTON SCIENTIFIC - FREMONT (SUD)
- Product Code
- DQO
- PMA / PMN Number
- K063312
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
UPDATED: DEVICE EVALUATED BY MANUFACTURER, EVALUATION SUMMARY ATTACHED, METHOD CODES, RESULT CODES, CONCLUSION CODES. DEVICE EVALUATED BY MANUFACTURER: THE DEVICE WAS RETURNED FOR ANALYSIS. THE IMAGING CORE, TELESCOPE, AND HUB ASSEMBLY WERE MISSING; ONLY THE SHEATH ASSEMBLY WAS RECEIVED. KINKS WERE OBSERVED IN THE SHEATH ASSEMBLY AT 20.1CM, 21.6CM, AND 22.6CM FROM FEMORAL MARKER AT THE PROXIMAL END. THE GUIDEWIRE EXIT PORT WAS LIFTED 1.0MM. A TEST GUIDEWIRE (0.014") WAS INSERTED AND NO INDICATION OF RESISTANCE IN TRACKING THE GUIDEWIRE INTO THE CATHETER WAS NOTED. FULL IMAGE CHARACTERIZATION TESTING CANNOT BE PERFORMED BASED ON THE RETURNED CONDITION OF THE CATHETER. NO OTHER ISSUES OR DEFECTS WERE OBSERVED DURING PRODUCT ANALYSIS OF THE RETURNED DEVICE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A PROBABLE ROOT CAUSE OF OPERATIONAL CONTEXT WAS ASSIGNED TO THE REPORTED COMPLAINT DUE TO PROCEDURAL/ANATOMICAL FACTORS THAT LIMITS ITS PERFORMANCE. (B)(4).
(B)(4).
SAME CASE AS MDR ID# 2134265-2013-02367. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A CATHETER WAS STUCK IN STENT AND THE STENT WAS DEFORMED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A PROMUS ELEMENT STENT WAS IMPLANTED IN THE LESION. THE STENT WAS POST-DILATED WITH AN UNKNOWN BALLOON CATHETER. THEY PERFORMED THE IVUS WITH THE ATLANTIS SR PRO IMAGING CATHETER. THE IMAGING CATHETER BECAME STUCK WITH THE EDGE OF THE STENT AND THE STENT WAS DEFORMED. THE PHYSICIAN THOUGHT THAT THE GUIDEWIRE EXIT PORT OF THIS DEVICE WAS STUCK WITH THE STENT. AN ATTEMPT TO RETRIEVE THE IMAGING CATHETER WAS PERFORMED BY CUTTING THE SHAFT OF THE CATHETER AND REMOVED ITS IMAGING CORE (DRIVE CABLE). THEN THEY ADVANCED THE 0.14 INCH UNKNOWN GUIDEWIRE AND REMOVED THE IMAGING CATHETER FROM THE STENT. TO REPAIR THE DEFORMED STENT, THEY POST-DILATE IT WITH AN UNKNOWN BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT STATUS POST PROCEDURE WAS LISTED AS GOOD.
SAME CASE AS MDR ID# 2134265-2013-02367. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A CATHETER WAS STUCK IN STENT AND THE STENT WAS DEFORMED. THE TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY. A PROMUS ELEMENT STENT WAS IMPLANTED IN THE LESION. THE STENT WAS POST-DILATED WITH AN UNKNOWN BALLOON CATHETER. THEY PERFORMED THE IVUS WITH THE ATLANTIS SR PRO IMAGING CATHETER. THE IMAGING CATHETER BECAME STUCK WITH THE EDGE OF THE STENT AND THE STENT WAS DEFORMED. THE PHYSICIAN THOUGHT THAT THE GUIDEWIRE EXIT PORT OF THIS DEVICE WAS STUCK WITH THE STENT. AN ATTEMPT TO RETRIEVE THE IMAGING CATHETER WAS PERFORMED BY CUTTING THE SHAFT OF THE CATHETER AND REMOVED ITS IMAGING CORE (DRIVE CABLE). THEN THEY ADVANCED THE 0.14 INCH UNKNOWN GUIDEWIRE AND REMOVED THE IMAGING CATHETER FROM THE STENT. TO REPAIR THE DEFORMED STENT, THEY POST-DILATE IT WITH AN UNKNOWN BALLOON CATHETER. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND THE PATIENT STATUS POST PROCEDURE WAS LISTED AS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 145333 | ATLANTIS¿ SR PRO² | CATHETER, INTRAVASCULAR, DIAGNOSTIC | DQO | BOSTON SCIENTIFIC - FREMONT (SUD) | H749390140 | 15741248 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |