SYNCHRO-14 STRAIGHT 200-35CM
Report
- Report Number
- 3012931345-2023-00255
- Event Type
- Malfunction
- Date Received
- December 12, 2023
- Date of Event
- November 28, 2023
- Report Date
- August 15, 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
H3 OTHER TEXT : THE DEVICE IS NOT AVAILABLE FOR EVALUATION.
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 FROM K032146 TO K002907 IN ACCORDANCE WITH THE GLOBAL UNIQUE DEVICE IDENTIFICATION DATABASE (GUDID).
H4 MANUFACTURING DATE ¿ ADDED. H3 DEVICE EVALUATED BY MFG ¿UPDATED. H3 SUMMARY ATTACHED - UPDATED. D4 EXPIRATION DATE - ADDED. D9 PRODUCT AVAILABLE TO STRYKER ¿ UPDATED. D9 RETURNED TO MANUFACTURER ON ¿UPDATED. DUE TO THE AUTOMATED MANUFACTURING EXECUTION SYSTEM (MES) SYSTEM THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. DURING VISUAL INSPECTION, THE GUIDEWIRE WAS RETURNED IN TWO FRAGMENTS (185CM FROM THE PROXIMAL END, GUIDEWIRE WAS BROKEN AT 14CM FROM THE DISTAL END). THE PROXIMAL FRAGMENT WAS INSPECTED AND WAS NOTED TO BE BROKEN ALONG THE NITINOL TUBING WITH THE CORE AND PLATINUM WIRE EXPOSED. THE DISTAL FRAGMENT WAS INSPECTED, AND THE NITINOL TUBING WAS SEEN TO BE BROKEN AND CORE/ PLATINUM WIRE EXPOSED. THE CORE WIRE DISTAL END WAS OBSERVED THROUGH THE DISTAL TIP DOME. FUNCTIONAL TESTING WAS NOT PERFORMED. THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. 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 THERE WAS NO DAMAGE NOTED TO THE PACKAGING PRIOR TO OPENING THE PACKAGING, THERE WAS NO ANOMALIES NOTED TO THE DEVICE DURING INITIAL INSPECTION AND PREPARATION, THE DEVICE WAS PREPARED FOR USE AS PER THE DIRECTIONS FOR USE, CONTINUOUS FLUSH WAS SET UP AND MAINTAINED THROUGHOUT THE CLINICAL PROCEDURE. THE PATIENTS ANATOMY WAS NOT TORTUOUS. DURING ANALYSIS THE GUIDEWIRE WAS RETURNED IN TWO FRAGMENTS (185CM AND 14CM). AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WAS ASSIGNED TO THE REPORTED AND ANALYZED DAMAGE OF THE GUIDEWIRE DISTAL TIP BROKEN/FRACTURED DURING USE 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.
IT WAS REPORTED THAT DURING THE STENOSIS PROCEDURE WHEN THE PHYSICIAN WAS ROTATING THE SUBJECT GUIDEWIRE, IT WAS HARD TO MANIPULATE. WHEN THE PHYSICIAN WITHDREW THE SUBJECT GUIDEWIRE, THE TIP OF IT WAS FOUND FRACTURED. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.
IT WAS REPORTED THAT DURING THE STENOSIS PROCEDURE WHEN THE PHYSICIAN WAS ROTATING THE SUBJECT GUIDEWIRE, IT WAS HARD TO MANIPULATE. WHEN THE PHYSICIAN WITHDREW THE SUBJECT GUIDEWIRE, THE TIP OF IT WAS FOUND FRACTURED. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.
IT WAS REPORTED THAT DURING THE STENOSIS PROCEDURE WHEN THE PHYSICIAN WAS ROTATING THE SUBJECT GUIDEWIRE, IT WAS HARD TO MANIPULATE. WHEN THE PHYSICIAN WITHDREW THE SUBJECT GUIDEWIRE, THE TIP OF IT WAS FOUND FRACTURED. THE PHYSICIAN REPLACED IT WITH A NEW DEVICE AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1304530 | SYNCHRO-14 STRAIGHT 200-35CM | WIRE, GUIDE, CATHETER | DQX | STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY | 0000221580 | 07613252186922 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Male | SL-10 CATHETER (STRYKER) |