SYNCHRO2-14 SOFT STRAIGHT 200CM
Report
- Report Number
- 3012931345-2022-00232
- Event Type
- Malfunction
- Date Received
- December 22, 2022
- Date of Event
- November 15, 2022
- Report Date
- March 17, 2023
- Manufacturer
- STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
- Product Code
- DQX
- UDI-DI
- 04546540688729
- PMA / PMN Number
- K053268
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.
H3 SUMMARY ATTACHED - UPDATED. H3 DEVICE EVALUATED BY MFG ¿UPDATED. H4 MANUFACTURING DATE ¿ ADDED. D4 EXPIRATION DATE - ADDED. D10 PRODUCT AVAILABLE TO STRYKER ¿ UPDATED. D10 RETURNED TO MANUFACTURER ON ¿UPDATED. THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. UPON VISUAL/MICROSCOPIC INSPECTION IT WAS NOTED THAT THE GUIDEWIRE WAS KINKED/BENT AT 23CM, 65CM, 155CM AND 172CM FROM THE PROXIMAL END. THE GUIDEWIRE WAS RETURNED BROKEN IN 2 SEGMENTS (14.5CM DISTAL SEGMENT AND 185.3CM PROXIMAL SEGMENT). IN THE PROXIMAL SEGMENT, THE NITINOL TUBING WAS RETURNED BROKEN WITH THE CORE WIRE EXPOSED. SEVERAL OTHER BREAKS WERE NOTED IN THE NITINOL TUBING IN THE PROXIMAL SEGMENT. IN THE DISTAL SEGMENT, THE NITINOL TUBING WAS RETURNED BROKEN WITH THE CORE WIRE EXPOSED. SEVERAL OTHER BREAKS WERE NOTED IN THE NITINOL TUBING IN THE DISTAL SEGMENT. THE GUIDEWIRE PTFE COATING WAS NOTED TO BE PEELING IN MULTIPLE AREAS TO 35CM FROM THE PROXIMAL END. THE CORE WIRE DISTAL END WAS OBSERVED THROUGH THE DISTAL TIP DOME. THE HYDROPHILIC COATING WAS HYDRATED AND THERE WERE NO ANOMALIES NOTED. A FUNCTIONAL INSPECTION COULD NOT BE PERFORMED AS THE DEVICE WAS DAMAGED. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTIONS FOR USE (DFU). AS WELL, THE RISK OF THE REPORTED EVENT IS DOCUMENTED IN THE RISK DOCUMENTATION AND THERE ARE CURRENT CONTROLS TO MITIGATE THE RISK OF THE AS REPORTED EVENT. THE REPORTED COMPLAINT WAS CONFIRMED BASED ON ANALYSIS. THE DEVICE FAILED TO MEET SPECIFICATIONS WHEN RECEIVED FOR COMPLAINT INVESTIGATION BASED ON THE ANALYZED ANOMALIES NOTED TO THE DEVICE. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER INDICATED THAT THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION DURING PREPARATION/PRIOR TO USE ON THE PATIENT AND WAS PREPARED AS PER THE DFU, CONTINUOUS FLUSH WAS SET UP AND MAINTAINED THROUGHOUT THE CLINICAL PROCEDURE, THE PATIENT'S ANATOMY WAS MODERATELY TORTUOUS, TWO CATHETERS WERE USED IN CONJUNCTION WITH THE SUBJECT DEVICE, THE GUIDEWIRE TIP WAS NOT SHAPED, FRICTION/RESISTANCE WAS ENCOUNTERED DURING ADVANCEMENT TO THE LESION, AND THE WHOLE GUIDEWIRE WAS IN THE MICROCATHETER AND WAS TAKEN OUT TOGETHER WITH THE MICROCATHETER. NO FRACTURED COMPONENTS WERE LEFT IN THE PATIENT'S ANATOMY. THE GUIDEWIRE WAS RETURNED BROKEN IN 2 SEGMENTS (14.5CM DISTAL SEGMENT AND 185.3CM PROXIMAL SEGMENT) WITH THE CORE WIRE EXPOSED, CONFIRMING THE REPORTED EVENT. SEVERAL SMALL BREAKS ON THE NITINOL TUBING OF BOTH SEGMENTS WERE ALSO FOUND. THE GUIDEWIRE WAS NOTED TO BE KINKED/BENT AT 23CM, 65CM, 155CM AND 172CM FROM THE PROXIMAL END. THE GUIDEWIRE PTFE COATING WAS NOTED TO BE PEELING IN MULTIPLE AREAS TO 35CM FROM THE PROXIMAL END. THE HYDROPHILIC COATING WAS HYDRATED AND THERE WERE NO ANOMALIES NOTED. BASED ON THE ANALYSIS, IT IS POSSIBLE THAT THE GUIDEWIRE MAY HAVE ENCOUNTERED SOME TENSION OR TORSION FORCES DURING USE THAT CAUSED THE DEVICE TO FRACTURE WHILE NAVIGATING INSIDE THE CATHETER. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE AS REPORTED AND AS ANALYZED 'GUIDEWIRE DISTAL TIP BROKEN/FRACTURED DURING USE' AS WELL AS THE AS REPORTED 'GUIDEWIRE FRICTION' AND AS ANALYZED 'GUIDEWIRE KINKED/BENT' SINCE THESE ISSUES ARE ASSOCIATED WITH A PRODUCT THAT MET STRYKER DESIGN AND MANUFACTURING SPECIFICATIONS AND WAS USED IN ACCORDANCE WITH THE DFU BUT PERFORMANCE WAS LIMITED DUE TO PROCEDURAL AND/OR ANATOMICAL FACTORS DURING USE. THE PTFE COATING DAMAGE MOST LIKELY OCCURRED AS A RESULT OF INTERACTION WITH THE INTRODUCER. THE DAMAGE NOTED IS CONSISTENT WITH BACKLOADING THE PROXIMAL END OF THE GUIDEWIRE INTO THE DISTAL END OF THE INTRODUCER AND PULLING IT THROUGH AT AN ANGLE. AN ASSIGNABLE CAUSE OF HANDLING DAMAGE WILL BE ASSIGNED TO THE AS ANALYZED ¿GUIDEWIRE PTFE COATING PEELING¿ AS THIS ISSUE IS DUE TO HANDLING OF THE PRODUCT OR PORTION OF THE PRODUCT DURING THE CLINICAL PROCEDURE, UPON REMOVAL OF THE PRODUCT FROM THE PACKAGING, OR PREPARATION OF THE PRODUCT PRIOR TO USE.
IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE, WHEN THE OPERATOR DELIVERED THE SUBJECT GUIDEWIRE ALONG WITH A MICROCATHETER INTO THE INTERMEDIATE CATHETER, THE SUBJECT GUIDEWIRE COULD NOT BE DELIVERED. WHEN THE OPERATOR WITHDREW THE SUBJECT GUIDEWIRE IT WAS NOTED THAT THE TIP OF THE SUBJECT GUIDEWIRE WAS FRACTURED. THE SUBJECT GUIDEWIRE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
IT WAS REPORTED THAT DURING A NEUROVASCULAR PROCEDURE, WHEN THE OPERATOR DELIVERED THE SUBJECT GUIDEWIRE ALONG WITH A MICROCATHETER INTO THE INTERMEDIATE CATHETER, THE SUBJECT GUIDEWIRE COULD NOT BE DELIVERED. WHEN THE OPERATOR WITHDREW THE SUBJECT GUIDEWIRE IT WAS NOTED THAT THE TIP OF THE SUBJECT GUIDEWIRE WAS FRACTURED. THE SUBJECT GUIDEWIRE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1630870 | SYNCHRO2-14 SOFT STRAIGHT 200CM | WIRE, GUIDE, CATHETER | DQX | STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY | M00326010 | 0000150879 | 04546540688729 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Female | AXS CATALYST 6 INTERMEDIATE CATHETER (STRYKER)| REBAR18 MICROCATHETER (UNKNOWN) |