OPTIMA COIL SYSTEM
Report
- Report Number
- 3014162263-2023-00051
- Event Type
- Malfunction
- Date Received
- August 18, 2023
- Date of Event
- July 19, 2023
- Report Date
- October 4, 2023
- Manufacturer
- BALT USA
- Product Code
- HCG
- UDI-DI
- 00818053025723
- PMA / PMN Number
- K172390
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
BALT USA REFERENCE #(B)(4). THE RETURNED DEVICE WAS INSPECTED IN OUR QUALITY LABORATORY. DURING OUR ANALYSIS: - WE NOTED ONLY THE MICROCATHETER AND IMPLANT COIL WERE RETURNED; - WE OBSERVED THE SR THREAD ON THE PROXIMAL TIP OF THE IMPLANT COIL TO HAVE A TAPERED TIP AT THE BREAK POINT; - WE OBSERVED THE IMPLANT COIL TO BE SEVERELY DAMAGED NEAR THE PROXIMAL END; - WE OBSERVED THE MICROCATHETER TO HAVE A PERFORATION JUST PROXIMAL OF THE MICROCATHETER DISTAL TIP, WITH A DIAMETER OF APPROXIMATELY 1MM; - WE OBSERVED THE PROXIMAL END OF THE IMPLANT COIL TO BE LOOPED WITHIN THE PERFORATION ON THE DISTAL TIP OF THE MICROCATHETER; - WE OBSERVED A SIGNIFICANT KINK TO THE LUMEN OF THE MICROCATHETER LOCATED 62MM PROXIMAL OF THE MICROCATHETER DISTAL TIP. ROOT CAUSE OF THE REPORTED ISSUE ENDURED BY THE COIL SYSTEM CAN BE ATTRIBUTED TO THE IMPLANT BECOMING CAUGHT ON THE DAMAGED MICROCATHETER. UPON DEVICE RETURN, WE OBSERVED THE SR THREAD ON THE PROXIMAL TIP OF THE IMPLANT COIL TO HAVE A TAPERED TIP AT THE BREAK POINT AS WELL AS THE IMPLANT COIL TO BE SEVERELY DAMAGED NEAR THE PROXIMAL END. IN ADDITION, WE OBSERVED THE MICROCATHETER TO HAVE A PERFORATION JUST PROXIMAL OF THE MICROCATHETER DISTAL TIP AND THE PROXIMAL END OF THE IMPLANT COIL TO BE LOOPED WITHIN THE PERFORATION. WE ALSO OBSERVED A SIGNIFICANT KINK TO THE LUMEN OF THE MICROCATHETER LOCATED 62MM PROXIMAL OF THE MICROCATHETER DISTAL TIP. IT WAS REPORTED A SECOND OPTIMA COMPLEX SUPERSOFT 1X3 WAS OPENED AND DEPLOYED WITH EASE, HOWEVER, DR. (B)(6) NOTED THAT AS HE PULLED BACK MIRCOCATHETER THAT THE COIL WAS "STUCK" AND MOVING WITH MICROCATHETER. FROM OUR OBSERVATIONS, THE IMPLANT COIL HAD BEEN THREADED THROUGH A HOLE ALONG THE WALL OF THE MICROCATHETER AT THE DISTAL TIP. AT THE PERFORATION, THE MATERIAL FROM THE MICROCATHETER WAS FOUND TO BE EXTRUDED OUTWARD AND PEELED BACK ALONG THE OUTER SURFACE. ADDITIONAL BENCH TESTING WAS PERFORMED AND INDICATED THE HOLE FOUND IN THE RETURNED MICROCATHETER WAS CAUSED BY PERFORATION, AND NOT THE DETACHMENT OF THE COIL SYSTEM. THEREFORE, THE REPORTED ISSUE ENDURED BY THE COIL SYSTEM CAN BE ATTRIBUTED TO THE IMPLANT BECOMING CAUGHT ON THE DAMAGED MICROCATHETER. THE CAUSE OF THE DAMAGE SUSTAINED BY THE MICROCATHETER AND THE SCENARIO IN WHICH THE IMPLANT ULTIMATELY BECAME STUCK IN THE DAMAGED MICROCATHETER CANNOT BE DEFINITIVELY DETERMINED OR RECREATED. HOWEVER, IT'S LIKELY THE PERFORATION WAS CAUSED FROM A SECONDARY DEVICE. REVIEW OF THE LOT HISTORY RECORDS DID NOT REVEAL ANY IN-PROCESS OR LOT-SPECIFIC ISSUE THAT COULD ACCOUNT FOR THE OBSERVATION. NO ADDITIONAL COMPLAINTS AGAINST LOT NUMBER F220701378 HAS BEEN MADE FOR THE SAME ISSUE. COMPREHENSIVE ANALYSIS OF THIS FAILURE MODE HAS REMAINED SUBJECT TO MONITORING FOR ANY UNACCEPTABLE INCREASE IN TREND. THE SUBMISSION OF THIS REPORT OR RELATED INFORMATION TO THE FDA, AND ITS RELEASE BY FDA, DOES NOT REFLECT A CONCLUSION BY THE PARTY SUBMITTING THIS REPORT OF THE FDA THAT THE REPORT OR RELATED INFORMATION IS AN ADMISSION THAT THE MANUFACTURER, THEIR EMPLOYEES, OR THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
BALT USA REFERENCE (B)(4). PENDING SUSPECTED DEVICE ANALYSIS. THE SUBMISSION OF THIS REPORT OR RELATED INFORMATION TO THE FDA, AND ITS RELEASE BY FDA, DOES NOT REFLECT A CONCLUSION BY THE PARTY SUBMITTING THIS REPORT OF THE FDA THAT THE REPORT OR RELATED INFORMATION IS AN ADMISSION THAT THE MANUFACTURER, THEIR EMPLOYEES, OR THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTABLE EVENT.
IT WAS REPORTED THAT: "A SECOND OPTIMA COMPLEX SUPERSOFT 1X3 WAS OPENED AND DEPLOYED WITH EASE THROUGH THE SAME HEADWAY DUO 167CM MICROCATHETER. THE COIL WAS DETACHED AND PUSHER WIRE WAS REMOVED. DR. (B)(6) NOTED THAT AS HE PULLED BACK MIRCOCATHETER THAT THE COIL WAS "STUCK" AND MOVING WITH MICRO. HE INTRODUCED A GUIDEWIRE INTO MICROCATHER AND ADVANCED OUT THE TIP OF CATHETER MANIPULATING WIRE BACK AND FORTH TO ATTEMPT TO DISLODGE COIL. THE COIL CONTINUED TO ADHERE TO CATHETER. DR. (B)(6) REMOVED MICROCATHETER SYSTEM AND THE COIL CAME BACK WITH CATHETER. THE PHYSICIAN AND TECH OBSERVED THE COIL TO BE "STUCK" TO OUTSIDE OF MICRO CATHETER ON BACK TABLE. A NEW MICROCATHETER SYSTEM ALONG WITH PERIPHERAL PUSHABLE COILS WERE USED TO SUCCESSFULLY COMPLETE CASE." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.
IT WAS REPORTED THAT: "A SECOND OPTIMA COMPLEX SUPERSOFT 1X3 WAS OPENED AND DEPLOYED WITH EASE THROUGH THE SAME HEADWAY DUO 167CM MICROCATHETER. THE COIL WAS DETACHED AND PUSHER WIRE WAS REMOVED. DR. (B)(6) NOTED THAT AS HE PULLED BACK MIRCOCATHETER THAT THE COIL WAS "STUCK" AND MOVING WITH MICRO. HE INTRODUCED A GUIDEWIRE INTO MICROCATHER AND ADVANCED OUT THE TIP OF CATHETER MANIPULATING WIRE BACK AND FORTH TO ATTEMPT TO DISLODGE COIL. THE COIL CONTINUED TO ADHERE TO CATHETER. DR. (B)(6) REMOVED MICROCATHETER SYSTEM AND THE COIL CAME BACK WITH CATHETER. THE PHYSICIAN AND TECH OBSERVED THE COIL TO BE "STUCK" TO OUTSIDE OF MICRO CATHETER ON BACK TABLE. A NEW MICROCATHETER SYSTEM ALONG WITH PERIPHERAL PUSHABLE COILS WERE USED TO SUCCESSFULLY COMPLETE CASE." INCIDENT REPORT FORM SUBMITTED FOR THIS COMPLAINT INDICATES THAT NO PATIENT INJURY WAS SUSTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2167005 | OPTIMA COIL SYSTEM | OPTIMA | HCG | BALT USA | OPTI0103CSS10 | F220701378 | 00818053025723 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |