SYNCHRO2-14 SUPPORT STRAIGHT 215CM
Report
- Report Number
- 3012931345-2023-00259
- Event Type
- Malfunction
- Date Received
- December 14, 2023
- Date of Event
- December 6, 2023
- Report Date
- August 14, 2024
- Manufacturer
- STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
- Product Code
- DQX
- UDI-DI
- 07613327459630
- PMA / PMN Number
- K190843
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H3 OTHER TEXT : THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.
WE HAVE ADDRESSED THE FDA REQUEST, RECEIVED VIA EMAIL ON 8 JULY 2024: UPON REVIEW, WE HAVE DETERMINED THAT THE INFORMATION ABOUT THE SUSPECT MEDICAL DEVICES INVOLVED IN THE REPORTED EVENTS, SPECIFICALLY THE UNIQUE DEVICE IDENTIFIER (UDI) INFORMATION IN SECTION D OF THE FDA FORM 3500A, IS INCORRECT. PLEASE NOTE THAT THE GLOBAL UNIQUE DEVICE IDENTIFICATION DATABASE (GUDID) IS THE MASTER DATA REPOSITORY FOR DEVICE IDENTIFICATION INFORMATION. DATA SUBMITTED TO GUDID MUST MATCH THE DEVICE IDENTIFICATION DATA SUBMITTED FOR DEVICES INVOLVED IN MDR REPORTABLE EVENTS. IN ADDITION, PLEASE ENSURE THAT DEVICE IDENTIFICATION DATA SUBMITTED IN THE SUSPECT MEDICAL DEVICE SECTION OF THE FDA FORM 3500A MATCHES THE DEVICE IDENTIFICATION DATA IN THE GUDID. 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 K053268 TO K190843 IN ACCORDANCE WITH THE GLOBAL UNIQUE DEVICE IDENTIFICATION DATABASE (GUDID).
H4 MANUFACTURING DATE ¿ ADDED. D4 EXPIRATION DATE - ADDED. THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE SUBJECT DEVICE WAS NOT AVAILABLE; THEREFORE, A VISUAL INSPECTION AS WELL AS A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED. 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 UNABLE TO BE CONFIRMED AND IT CANNOT BE CONFIRMED THAT THE DEVICE MET SPECIFICATION, AS THE DEVICE WAS NOT RETURNED. IT WAS REPORTED THAT THE COATING STRIPPED OFF INTO SCRUB NURSE'S HAND BEFORE WIRE WAS INTRODUCED TO CATHETER. THERE WAS NO ADDITIONAL INFORMATION AVAILABLE. AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND THE AVAILABLE INFORMATION FAILS TO INDICATE AN ASSIGNABLE CAUSE FOR THE REPORTED EVENT, AN ASSIGNABLE CAUSE OF UNDETERMINABLE WILL BE ASSIGNED TO THE AS REPORTED 'GUIDEWIRE PTFE COATING PEELING'.
IT WAS REPORTED THAT COATING OF THE GUIDEWIRE (SUBJECT DEVICE) STRIPPED OFF INTO SCRUB NURSE'S HAND BEFORE WIRE WAS INTRODUCED TO CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO ADDITIONAL INFORMATION AVAILABLE.
IT WAS REPORTED THAT COATING OF THE GUIDEWIRE (SUBJECT DEVICE) STRIPPED OFF INTO SCRUB NURSE'S HAND BEFORE WIRE WAS INTRODUCED TO CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO ADDITIONAL INFORMATION AVAILABLE.
IT WAS REPORTED THAT COATING OF THE GUIDEWIRE (SUBJECT DEVICE) STRIPPED OFF INTO SCRUB NURSE'S HAND BEFORE WIRE WAS INTRODUCED TO CATHETER. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO ADDITIONAL INFORMATION AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1770006 | SYNCHRO2-14 SUPPORT STRAIGHT 215CM | WIRE, GUIDE, CATHETER | DQX | STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY | 0000065644 | 07613327459630 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |