GUIDESTAR STEERABLE GUIDING SHEATH
Report
- Report Number
- 1035166-2020-00071
- Event Type
- Injury
- Date Received
- November 18, 2020
- Date of Event
- September 25, 2020
- Report Date
- August 27, 2021
- Manufacturer
- OSCOR INC.
- Product Code
- DYB
- PMA / PMN Number
- K120459
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
SCOR INC. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY OSCOR INC. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, OSCOR INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.
THE FOLLOWING SECTIONS WERE UPDATED IN FOLLOW-UP 3. B3, B4, D4, G3, G6, H2, H4, H6, H10. THE INVESTIGATION WAS FOCUSED ON A REVIEW OF PRODUCT DOCUMENTATION. THE DEVICE HISTORY RECORDS WERE REVIEWED TO CONFIRM THAT THE DEVICE PASSED ALL APPLICABLE IN-PROCESS AND FINAL INSPECTIONS. OSCOR INC. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY OSCOR INC. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, OSCOR INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.
CORRECTION H4: CORRECTED DATE OF MANUFACTURING FROM 03/02/2020 TO12/02/2019 OSCOR INC. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY OSCOR INC. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, OSCOR INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.
CORRECTION H4: CORRECTED DATE OF MANUFACTURING FROM 12/02/2019 TO12/03/2019. OSCOR INC. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY OSCOR INC. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, OSCOR INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.
THE LOT NUMBER OF THIS DEVICE WAS NOT PROVIDED, THEREFORE NEITHER A REVIEW OF THE DEVICE HISTORY RECORD COULD BE PERFORMED. INSPECTION PROCEDURES REQUIRE ALL OSCOR PRODUCTS TO PASS ALL IN-PROCESS AND QA FINAL INSPECTIONS BEFORE SHIPPING TO THE CUSTOMER. SEVERAL ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL PATIENT AND EVENT INFORMATION, ALSO THE LOCATION OF THE DEVICE BUT ALL ATTEMPTS WERE UNSUCCESSFUL. DEVICE USED IN TREATMENT AND NOT RETURNED FOR ANALYSIS. THERE WAS NO SPECIFIC PERFORMANCE RELATED FAILURE REPORTED BY THE USER. NO FURTHER INVESTIGATION IS REQUIRED. BASED ON THE INVESTIGATION, A CAPA IS NOT REQUIRED AS FINDINGS DID NOT IDENTIFY A DESIGN, LABELING OR MANUFACTURING NON-CONFORMITY. IN ADDITION, THERE WAS NO NEW FAILURE MODE IDENTIFIED AND THE RISK REMAINS ACCEPTABLE. THE EVENT WILL BE RE-EVALUATED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. OSCOR WILL CONTINUE TO MONITOR THIS EVENT TYPE AND RISK. OSCOR INC. IS SUBMITTING THE ABOVE REPORT TO COMPLY WITH 21 CFR PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THE REPORT IS BASED UPON INFORMATION OBTAINED BY OSCOR INC. WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY FDA. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES, CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT. NOR DOES THIS REPORT REFLECT A CONCLUSION BY FDA, OSCOR INC., OR ITS EMPLOYEES, THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, OSCOR INC., OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THIS REPORT.
INVESTIGATION IS STILL IN PROGRESS.
IT WAS REPORTED THAT PATIENT HAD A RIGHT ILIAC VEIN TEAR FROM THE SHEATH, WHICH WAS DETECTED AT THE END OF THE CASE. THIS LIKELY HAPPENED WHEN EXCHANGING THE SL1 SHEATH TO THE GUIDESTAR SHEATH. THERE WAS A DROP IN HEMOGLOBIN, A VENOGRAM (IMAGE) WAS PERFORMED. THE PATIENT WAS DIAGNOSED WITH A TEAR, ATTEMPTS TO CLOSE PERCUTANEOUSLY FAILED; THEREFORE, PATIENT WAS SENT TO THE OR TO HAVE THE TEAR SURGICALLY REPAIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1325982 | GUIDESTAR STEERABLE GUIDING SHEATH | INTRODUCER, CATHETER, PRODUCT CODE: DYB | DYB | OSCOR INC. | D141101 | OR-04983 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |