SYNCHRO-14 STRAIGHT 200-35CM
Report
- Report Number
- 3012931345-2023-00244
- Event Type
- Malfunction
- Date Received
- November 13, 2023
- Date of Event
- September 12, 2023
- Report Date
- August 14, 2024
- Manufacturer
- STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
- Product Code
- DQX
- UDI-DI
- 07613252186922
- PMA / PMN Number
- K002907
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
WE HAVE ADDRESSED THE FDA REQUEST, RECEIVED VIA EMAIL ON 14 JUNE 2024: ¿UPON REVIEW, WE HAVE DETERMINED THAT THE DEVICE IDENTIFICATION INFORMATION ABOUT THE SUSPECT MEDICAL DEVICES CONFLICTS WITH THE DATA SUBMITTED TO THE GLOBAL UNIQUE DEVICE IDENTIFICATION DATABASE (GUDID)." "DISCREPANCIES WERE NOTED IN THE INFORMATION INCLUDED FOR SOME OR ALL OF THE DEVICE IDENTIFICATION FIELDS OF THE ELECTRONIC EQUIVALENT OF THE FDA FORM 3500A COMPARED TO THE INFORMATION INCLUDED FOR THE CORRESPONDING FIELDS IN THE GUDID." "ADDITIONALLY, THE ¿UNIQUE DEVICE IDENTIFIER (UDI) #¿ FIELD ON THE FDA FORM 3500A SHOULD CONTAIN THE ENTIRE UDI NUMBER INCLUDING THE DI AND PI FIELDS, ALL NUMBERS, LETTERS, PARENTHESES, AND SYMBOLS. PLEASE VERIFY THAT YOU HAVE INCLUDED THE ENTIRE UDI IN THE ¿UNIQUE DEVICE IDENTIFIER (UDI) #¿ FIELD ON THE 3500A." WE HAVE REVIEWED THE DEVICE IDENTIFIER (DI) AND CONFIRM THAT IT IS ACCURATE AND IN ALIGNMENT WITH THE HL7 SPECIFICATIONS RELEASED IN 2017. ADDITIONALLY: THE 510(K) NUMBER HAS BEEN CORRECTED FROM K032146 TO K002907 IN ACCORDANCE WITH THE GLOBAL UNIQUE DEVICE IDENTIFICATION DATABASE (GUDID).
THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. DURING VISUAL/MICROSCOPIC INSPECTION, THE GUIDEWIRE WAS RETURNED AND A KINK/BEND WAS NOTED 1.3CM KINK FROM DISTAL END. THE CORE WIRE DISTAL END WAS OBSERVED THROUGH THE DISTAL TIP DOME. ENCRUSTED DRIED BLOOD WAS PRESENT AT THE DISTAL END. THE HYDROPHILIC COATING WAS HYDRATED AND THE SURFACE OF THE HYDROPHILIC COATING WAS FOUND TO BE ROUGH BETWEEN APPROXIMATELY 0.5CM TO 13CM FROM THE DISTAL END. BUBBLES WITH UNCOLLAPSED AND COLLAPSED DOME AND UNKNOWN SUBSTANCE (APPEARED TO BE EXCESSIVE COATING) WERE FOUND ALONG THE DISTAL SEGMENT. THE NITINOL TUBING WAS BROKEN 7.5CM FROM THE DISTAL END AND THE PLATINUM COIL WAS EXPOSED BUT NOT BROKEN. THE GUIDEWIRE WAS SOAKED IN WATER. AFTER SOAKING THE GUIDEWIRE, IT WAS INSPECTED WET. THE GUIDEWIRE DISTAL TIP REVEALED NO SWELLING/BULGE ON ITS DISTAL TIP. THE GUIDEWIRE POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS EXAMINED UNDER MAGNIFICATION AND THE PTFE. THE COATING WAS PRESENT ON THE GUIDEWIRE. NO ANOMALIES WERE OBSERVED WITH THE PTFE COATING. FUNCTIONAL INSPECTION WAS NOT APPLICABLE DUE TO DAMAGE TO HYDROPHILIC COATING 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 THE DEVICE ANALYSIS. THE DEVICE FAILED TO MEET SPECIFICATIONS WHEN RECEIVED FOR COMPLAINT INVESTIGATION DUE TO THE ANALYZED ANOMALIES. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER DID NOT INDICATE ANY ISSUES NOTED DURING UNPACKING OR SET UP OF THE DEVICE, AND THE DEVICE WAS PREPARED AS PER DFU INSTRUCTIONS. THE PATIENT¿S ANATOMY WAS MODERATELY TORTUOUS. THE SAME MICROCATHETER WAS USED TO FINISH THE PROCEDURE AND THERE WAS NO ALLEGATION AGAINST THE MICROCATHETER. THE BUBBLES FOUND ON THE DISTAL END OF THE DEVICE WERE ANALYZED BY R&D. BASED ON THE RESULTS OF SEM (SCANNING ELECTRON MICROSCOPE) AND EDX (ENERGY DISPERSIVE X-RAY) TESTING, IT APPEARS THAT THE BUBBLES AND THE CONTROL SECTION OF THE COATING ARE THE SAME SUBSTANCE. THE CAUSE OF COATING BUBBLES, WHICH ARE LIKELY HYDROPHILIC COATING, COULD NOT BE DEFINITIVELY DETERMINED BUT MOST LIKELY OCCURRED DURING MANIPULATION OF THE DEVICE WHILE IN THE PATIENT¿S ANATOMY. IT WAS ALSO NOTED THE NITINOL TUBING WAS BROKEN 7.5CM FROM THE DISTAL END AND THE PLATINUM COIL WAS EXPOSED BUT NOT BROKEN. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE AS REPORTED ¿GUIDEWIRE DIFFICULT TO ADVANCE¿ AND AS ANALYZED 'GUIDEWIRE DISTAL TIP BROKEN/FRACTURED DURING USE¿, ¿GUIDEWIRE DISTAL END/TIP KINKED/BENT¿ AND ¿GUIDEWIRE HYDROPHILIC COATING SURFACE ROUGH¿ WILL BE ASSIGNED TO THIS INVESTIGATION AS THE ISSUE IS ASSOCIATED WITH A PRODUCT THAT MEETS STRYKER DESIGN AND MANUFACTURE SPECIFICATIONS AND WAS USED IN ACCORDING WITH THE DFU BUT DUE TO PROCEDURAL AND/OR ANATOMICAL FACTORS DURING USE, THE PRODUCT PERFORMANCE WAS LIMITED.
ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE DISTAL TIP OF THE SUBJECT GUIDEWIRE WAS BROKEN/FRACTURED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE DISTAL TIP OF THE SUBJECT GUIDEWIRE WAS BROKEN/FRACTURED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2219920 | SYNCHRO-14 STRAIGHT 200-35CM | WIRE, GUIDE, CATHETER | DQX | STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY | 0000194330 | 07613252186922 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Female | EXCELSIOR SL-10 MICROCATHETER (STRYKER). |