SCEPTER C
Report
- Report Number
- 2032493-2024-00388
- Event Type
- Malfunction
- Date Received
- May 15, 2024
- Report Date
- July 12, 2024
- Manufacturer
- MICROVENTION INC.
- Product Code
- DQY
- PMA / PMN Number
- K121785
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE WAS DISCARDED AT THE USER FACILITY AND NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. HOWEVER, VIDEOS WERE PROVIDED. THE INVESTIGATION IS ONGOING. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MDR WILL BE SUBMITTED.
A CORRECTION WAS MADE IN SECTION D2. THE ORIGINAL D2A COMMON DEVICE NAME INTRAVASCULAR OCCLUDING CATHETER IS NOT CORRECT AND IT WAS CORRECTED TO BALLOON CATHETER. THE ORIGINAL D2B DEVICE PRODUCT CODE MJN IS NOT CORRECT AND IT WAS CORRECTED TO DQY. THE DEVICE WAS DISCARDED AT THE USER FACILITY AND NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. THE MODEL/CATALOG AND LOT NUMBER ARE ALSO UNAVAILABLE DESPITE OUR ATTEMPT TO OBTAIN THIS INFORMATION. THEREFORE, THE UDI AND PRIMARY DI NUMBER ARE NOT KNOWN. TWO PROCEDURAL VIDEOS WERE PROVIDED FOR ANALYSIS. TWO VIDEO FILES ARE SUBMITTED. THEY ARE NOT LABELED AS TO DATE OR TIME. EVEN THOUGH NO CONTRAST HAS BEEN INJECTED, IT APPEARS THAT THE DEVICES ARE LOCATED IN THE RIGHT SUPRACLINOID ICA. VIDEO 1: 29 SECOND VIDEO, NON-SUBTRACTED, NO CONTRAST, AP OBLIQUE CENTERED OVER THE RIGHT ORBIT. A DENSE COIL BALL IS SEEN IN WHAT IS EITHER A SUPERIOR HYPOPHYSEAL OR A PCOM ANEURYSM. THERE IS A STENT (MARKERS SEEN DISTAL AND PROXIMAL TO THE ANEURYSM; I DO NOT KNOW WHAT STENT THIS IS) IN THE SUPRACLINOID ICA. A SCEPTER BALLOON WITH A GUIDEWIRE IS SEEN. THE TIP OF THE SCEPTER IS INSIDE THE DISTAL STENT; THE DISTAL PART OF THE SCEPTER IS PARTIALLY INFLATED. THE WIRE IS DISTAL TO THE TIP OF THE SCEPTER. THE VIDEO SHOWS THE SCEPTER BEING REMOVED ALONG WITH THE WIRE, WITH THE SCEPTER STILL INFLATED, AS DESCRIBED IN THE COMPLAINT. VIDEO 2: 18 SECOND VIDEO, SUBTRACTED, CONTRAST, AP OBLIQUE CENTERED OVER THE RIGHT ORBIT. THIS VIDEO SHOWS THE SAME MANEUVER AS DESCRIBED ABOVE BUT IS SUBTRACTED. THESE VIDEOS DO NOT EXPLAIN WHY THE SCEPTER BALLOON DID NOT DEFLATE. BATCH REVIEW: A SEARCH FOR NON-CONFORMANCES ASSOCIATED WITH THIS PART/LOT NUMBER COMBINATION COULD NOT BE PERFORMED AS THIS INFORMATION WAS NOT AVAILABLE AT THE TIME THIS INVESTIGATION WAS PERFORMED. COMPLAINT SYSTEM REVIEW: A SEARCH OF THE COMPLAINT HANDLING SYSTEM COULD NOT BE PERFORMED TO DETERMINE IF OTHER SIMILAR COMPLAINTS EXIST FOR THIS BATCH NUMBER, BECAUSE THE BATCH NUMBER WAS NOT PROVIDED FOR THE PRODUCT ON THIS COMPLAINT FILE. BASED ON A REVIEW OF THE DEVICE¿S RISK DOCUMENTATION, THE REPORTED EVENT DID NOT INDICATE THERE WERE ANY POTENTIAL OR NEW MANUFACTURING, DESIGN, QUALITY, OR OTHER SYSTEMIC ISSUES, OR NON-CONFORMANCES. THE COMPLAINT CODE IS MONITORED THROUGH THE TRENDING PROCESS; CORRECTIVE ACTION IS DETERMINED, AS NEEDED, THROUGH THIS PROCESS. INVESTIGATIONS OF HISTORIC COMPLAINT FILES WITH SIMILAR COMPLAINT CATEGORY CODING ARE RECORDED IN THE COMPLAINT HANDLING SYSTEM; WITHOUT THE ABILITY TO PERFORM AN ANALYSIS OF THE DEVICE, THIS INVESTIGATION CANNOT IDENTIFY WITH CERTAINTY ANY POTENTIAL ROOT CAUSES. IFU REVIEW (ADDITIONAL INFORMATION CAN BE FOUND IN THE IFU, THE FOLLOWING IS TAKEN FROM THE 27 LANGUAGE VERSION): POTENTIAL COMPLICATIONS: POTENTIAL COMPLICATIONS INCLUDE BUT ARE NOT LIMITED TO: VESSEL OR ANEURYSM PERFORATION, VASOSPASM, HEMATOMA AT THE SITE OF ENTRY, EMBOLISM, ISCHEMIA, INTRACEREBRAL/INTRACRANIAL HEMORRHAGE, PSEUDOANEURYSM, SEIZURE, STROKE, INFECTION, VESSEL DISSECTION, THROMBUS FORMATION, AND DEATH. PRECAUTIONS: AFTER BALLOON PREPARATION FOR USE AND PRIOR TO USE, RE-INFLATE TO NOMINAL VOLUME AND INSPECT FOR ANY IRREGULARITIES OR DAMAGE. DO NOT USE IF ANY INCONSISTENCIES ARE OBSERVED. THE BALLOON CATHETER HAS A LUBRICIOUS SURFACE AND SHOULD BE HYDRATED PRIOR TO USE. ONCE THE BALLOON CATHETER IS HYDRATED, DO NOT ALLOW IT TO DRY. EXERCISE CARE IN HANDLING THE BALLOON CATHETER TO REDUCE THE CHANCE OF ACCIDENTAL DAMAGE. WITH THE EXCEPTION OF DIMETHYL SULFOXIDE (DMSO), USE OF OTHER ORGANIC SOLVENTS MAY DAMAGE THE BALLOON CATHETER AND/OR COATING ON THE SURFACE. TAKE PRECAUTION WHEN MANIPULATING THE BALLOON CATHETER IN TORTUOUS VASCULATURE TO AVOID DAMAGE. AVOID ADVANCEMENT OR WITHDRAWAL AGAINST RESISTANCE UNTIL THE CAUSE OF RESISTANCE IS DETERMINED. PRESENCE OF CALCIFICATIONS, IRREGULARITIES OR EXISTING DEVICES MAY DAMAGE THE BALLOON CATHETER AND POTENTIALLY AFFECT ITS INSERTION OR REMOVAL. EXCESSIVE TORQUE APPLIED TO THE SYRINGE MIGHT RESULT IN DAMAGE TO THE SCEPTER HUB ASSEMBLY. DIRECTIONS FOR USE (REFER TO DIAGRAM FOR REFERENCE): 1. ATTACH A ROTATING HEMOSTATIC VALVE (RHV) TO THE GUIDEWIRE LUMEN OF THE BALLOON CATHETER. SET UP A CONTINUOUS SALINE FLUSH LINE AND CONNECT IT TO THE SIDEARM OF THE RHV. 2. CHOOSE APPROPRIATE GUIDING OR DIAGNOSTIC CATHETER. ATTACH A RHV TO THE PROXIMAL HUB OF THE GUIDING OR DIAGNOSTIC CATHETER. TO PREVENT BACKFLOW OF BLOOD INTO THE LUMEN OF THE CATHETER, CONNECT THE CONTINUOUS SALINE FLUSH LINE TO THE SIDEARM OF THE RHV. 3. OPEN THE RHV ON THE HUB OF THE GUIDING OR DIAGNOSTIC CATHETER AND INTRODUCE THE BALLOON CATHETER/GUIDEWIRE INTO THE GUIDING CATHETER USING THE INTRODUCER SHEATH. CAREFULLY ADVANCE THE BALLOON CATHETER/GUIDEWIRE TO THE GUIDING CATHETER DISTAL TIP. AFTER THE BALLOON CATHETER/GUIDEWIRE REACHES THE TIP OF THE GUIDING CATHETER, REMOVE THE INTRODUCER FROM THE BALLOON CATHETER SHAFT BY RETRACTING THE INTRODUCER FROM THE RHV AND PEELING OFF THE INTRODUCER. ADVANCE THE BALLOON CATHETER THROUGH THE RHV. 4. ADVANCE THE BALLOON CATHETER AND GUIDEWIRE TO THE DESIRED LOCATION IN THE VASCULATURE USING FLUOROSCOPIC VISUALIZATION. CAREFULLY TIGHTEN THE VALVE OF THE RHV AROUND THE BALLOON CATHETER TO PREVENT LEAKAGE FROM THE RHV. THE RHV SHOULD STILL ALLOW FOR BALLOON CATHETER ADVANCEMENT AFTER TIGHTENING. WARNING: DO NOT OVER-TIGHTEN THE RHV AROUND THE BALLOON CATHETER. OVER-TIGHTENING COULD DELAY BALLOON INFLATION AND DEFLATION. WARNING: DO NOT ADVANCE THE BALLOON CATHETER OR GUIDEWIRE AGAINST RESISTANCE. IF RESISTANCE IS FELT, ASSESS THE SOURCE OF RESISTANCE USING FLUOROSCOPIC MEANS. 5. ATTACH A 2-WAY STOPCOCK TO A 1CC SYRINGE FILLED WITH APPROPRIATE CONTRAST SOLUTION. PRIME THE 2-WAY STOPCOCK SO THAT NO AIR IS PRESENT. SLOWLY INFLATE THE BALLOON TO THE RECOMMENDED VOLUME TO ACHIEVE THE DESIRED DIAMETER AS DESCRIBED IN TABLE 3. WARNING: DO NOT EXCEED THE MAXIMUM RECOMMENDED INFLATION VOLUME AS BALLOON RUPTURE MAY OCCUR. WARNING: ALWAYS INFLATE AND DEFLATE THE BALLOON WHILE VISUALIZING UNDER FLUOROSCOPY TO ENSURE PATIENT SAFETY. 6. AFTER INFLATION, LOCK THE STOPCOCK IF DESIRED. 7. IF DESIRED, REMOVE THE GUIDEWIRE FROM THE BALLOON CATHETER AND PREPARE PER THE RESPECTIVE DIAGNOSTIC OR THERAPEUTIC AGENT IFU(S) FOR DELIVERY THROUGH THE GUIDEWIRE LUMEN. WARNING: EXCESSIVE PRESSURE HIGHER THAN 700PSI (4826KPA, 47.6ATM) MAY CAUSE LEAKAGE OR RUPTURE OF THE GUIDEWIRE LUMEN. 8. WHEN DEFLATING BALLOON, USE FLUOROSCOPY TO ENSURE COMPLETE DEFLATION PRIOR TO REMOVAL. SEE TABLE 1 FOR RESPECTIVE DEFLATION TIMES. AFTER PROCEDURE IS COMPLETE, SLOWLY REMOVE THE BALLOON CATHETER AND GUIDEWIRE.
IT WAS REPORTED THAT THE BALLOON WOULD NOT DEFLATE DURING THE BALLOON AND STENT-ASSISTED COILING. THE DOCTOR INFLATED THE BALLOON WITHIN THE STENT TO ATTEMPT TO MAKE THE SIZE OF THE OPENING LARGER, BUT THE BALLOON WOULD NOT DEFLATE. THE INFLATED BALLOON WAS REMOVED FROM THE PATIENT. IT WAS ALSO REPORTED THERE WAS BLOOD FLOWING INTO THE LUMEN. THERE WAS NO INTERVENTION OR INJURY.
SEE H.11.
ADDITIONAL INFORMATION WAS RECEIVED THAT STATED THE PROCEDURE WAS COMPLETED WITHOUT ANY ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2346838 | SCEPTER C | BALLOON CATHETER | DQY | MICROVENTION INC. | UNKNOWN | UNKNOWN | |
| 618891 | SCEPTER C | BALLOON CATHETER | DQY | MICROVENTION INC. | UNKNOWN | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |