SYNCHRO-10 STRAIGHT 200CM
Report
- Report Number
- 3012931345-2023-00239
- Event Type
- Malfunction
- Date Received
- November 7, 2023
- Date of Event
- October 5, 2023
- Report Date
- August 15, 2024
- Manufacturer
- STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
- Product Code
- DQX
- UDI-DI
- 07613252187158
- PMA / PMN Number
- K023700
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KS
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, VISUAL TESTING AS WELL AS FUNCTIONAL TESTING CANNOT 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 COULD NOT BE CONFIRMED, AND IT COULD NOT BE DEFINITIVELY DETERMINED IF THE DEVICE FAILED TO MEET SPECIFICATIONS BECAUSE THE PRODUCT WAS NOT RETURNED. AN ASSIGNABLE CAUSE OF UNDETERMINABLE WILL BE ASSIGNED TO REPORTED EVENT OF 'GUIDEWIRE DISTAL TIP BROKEN/FRACTURED DURING USE' AS THE DEVICE WAS NOT RETURNED AND A REVIEW OF ALL AVAILABLE INFORMATION FAILS TO INDICATE A PROBABLE ASSIGNABLE CAUSE.
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 K023700 IN ACCORDANCE WITH THE GLOBAL UNIQUE DEVICE IDENTIFICATION DATABASE (GUDID).
H3 OTHER TEXT : THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.
IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE, THE SUBJECT GUIDEWIRE DISTAL TIP WAS DETACHED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO OTHER INFORMATION IS AVAILABLE.
IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE, THE SUBJECT GUIDEWIRE DISTAL TIP WAS DETACHED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO OTHER INFORMATION IS AVAILABLE.
IT WAS REPORTED THAT DURING AN ENDOVASCULAR PROCEDURE, THE SUBJECT GUIDEWIRE DISTAL TIP WAS DETACHED. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. NO OTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 351375 | SYNCHRO-10 STRAIGHT 200CM | WIRE, GUIDE, CATHETER | DQX | STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY | 0000108142 | 07613252187158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Male |