GUIDESTAR¿ STEERABLE GUIDING SHEATH
Report
- Report Number
- 1035166-2022-00015
- Event Type
- Malfunction
- Date Received
- January 25, 2022
- Date of Event
- January 11, 2022
- Report Date
- July 6, 2022
- Manufacturer
- OSCOR INC.
- Product Code
- DYB
- UDI-DI
- 00885672009496
- PMA / PMN Number
- K140406
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- 003
Narratives
CONCLUSION NOT YET AVAILABLE, EVALUATION IN PROCESS. A FOLLOW-UP WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETE.
H2: CORRECTION MADE IN SECTION H10: DELETED MANUFACTURING PROCEDURE ADELANTE MAGNUM AND DESTINO MAGNUM SHEATH ASSEMBLY (THIS PROCEDURE WAS REPORTED IN ERROR, PROCEDURE IS NOT APPLICABLE). PER MANUFACTURING PROCEDURE ADELANTE MAGNUM AND DESTINO MAGNUM SHEATH ASSEMBLY: SAMPLE SIZE 100%: THE VALVES ARE VISUALLY INSPECTED BEFORE FINAL ASSEMBLY. LEAK TEST CURED SHEATH ASSEMBLIES. 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.
CONCLUSION NOT YET AVAILABLE, EVALUATION IN PROCESS. A FOLLOW-UP WILL BE SUBMITTED AS SOON AS THE INVESTIGATION IS COMPLETE. 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 DEVICE WAS USED IN TREATMENT. ONE 13.5F GUIDESTAR STEERABLE GUIDING SHEATH WAS RECEIVED WITHOUT THE DILATOR. THERE WERE NO OTHER ACCESSORIES. TRACES OF BLOOD WERE FOUND ON AND INSIDE THE SHEATH. ACCORDING TO THE EVENT DESCRIPTION SUMMARY, THE VALVE WAS LEAKING FROM THE SIDE AND WHEN THE PHYSICIAN PUSHED THE BALLOON OUT OF THE SHEATH AND PULLED IT BACK INSIDE, THE DEFLECTION BROKE. THE VALVE WAS VIEWED UNDER A 10X MICROSCOPE AND LOOKED NORMAL WITH NO ANOMALIES. THE SHEATH WAS MANUALLY LEAK TESTED WITH THE SYRINGE CONNECTED TO THE STOPCOCK AND THE TIP OCCLUDED. THE SHEATH DID NOT EXHIBIT LEAKAGE WHEN TESTED USING THIS METHOD. THE SHEATH WAS THEN TESTED USING THE ISO 11070 FOR LIQUID LEAKAGE TEST METHOD. THE DEVICE WAS OCCLUDED AT THE DISTAL TIP AND PRESSURIZED TO 38KPA AND HELD AT THIS PRESSURE FOR 30 SECONDS AND NO LEAKAGE WAS OBSERVED FROM THE HEMOSTATIC VALVE. THE SHEATH WAS FURTHER PRESSURIZED BEYOND 300KPA AND NO LEAKAGE WAS OBSERVED FROM THE STOPCOCK, SIDEPORT OR THROUGH THE HANDLE. THE SHEATH WOULD ALSO NO LONGER DEFLECT. X-RAYS REVEALED THAT THE ANCHOR RING AND PULLWIRE REMAINED IN ITS ORIGINAL INTENDED POSITION. THE HYPOTUBES WERE INTACT. THE SHEATH WOULD NO LONGER DEFLECT DUE TO THE BROKEN PULLWIRE WHICH IS LOCATED APPROXIMATELY 5.5CM FROM THE DISTAL TIP. THERE IS A KINK IN THE DEFLECTION SECTION OF THE SHEATH SHAFT APPROXIMATELY 5.5CM FROM THE DISTAL TIP WHICH COINCIDES WITH THE LOCATION OF THE BROKEN PULLWIRE. IT IS LIKELY THAT THE FORCE IT TOOK TO PUSH AND PULL THE BALLOON FROM THE SHEATH CONTRIBUTED TO THE BREAKAGE OF THE PULLWIRE AND THE KINK. ACCORDING TO THE DEVICE HISTORY RECORDS, THE INTRODUCER SHEATH PASSED ALL IN-PROCESS AND QA FINAL INSPECTION STEPS BEFORE SHIPPING TO THE CUSTOMER INCLUDING VISUAL, DIMENSIONAL, MECHANICAL AND LEAK TESTING. RETURNED DEVICE ANALYSIS REVEALED THE SHEATH IS WITHIN MANUFACTURING SPECIFICATIONS. ACCORDING TO THE EVENT DESCRIPTION SUMMARY, THE SHEATH LEAKED FROM THE SIDE OF THE VALVE AND WOULD NO LONGER DEFLECT. THE SHEATH DID NOT LEAK WHEN TESTED MANUALLY AND ALSO MET THE ISO LEAKAGE TEST REQUIREMENT. THE SHEATH WOULD NO LONGER DEFLECT. IT IS LIKELY THAT THE FORCE IT TOOK TO PUSH AND PULL THE BALLOON IN AND OUT OF THE SHEATH CONTRIBUTED TO THE BREAKAGE OF THE PULLWIRE CAUSING THE SHEATH TO NO LONGER DEFLECT. PER MANUFACTURING PROCEDURE ADELANTE MAGNUM AND DESTINO MAGNUM SHEATH ASSEMBLY: SAMPLE SIZE 100%: THE VALVES ARE VISUALLY INSPECTED BEFORE FINAL ASSEMBLY. LEAK TEST CURED SHEATH ASSEMBLIES. PER QA PROCEDURE DESTINO STEERABLE GUIDING SHEATH IN-PROCESS AND FINAL INSPECTION: SAMPLE SIZE: ANSI Z 1.4, GEN LEVEL I, NORMAL, AQL 1.5 NORMAL PERFORM LEAK TEST ACCORDING TO PROCEDURE BASED ON AVAILABLE LEAK TESTER. THE LEAK TEST IS PERFORMED BY MANUFACTURING PERSONNEL AT 100% AND IS OBSERVED BY QUALITY ASSURANCE PERSONNEL. THE DEFLECTION TEST IS PERFORMED 100% BY MANUFACTURING PERSONNEL AND INSPECTED BY QUALITY PERSONNEL AT AN AQL LEVEL (SAMPLE SIZE: ANSI Z 1.4, GEN LEVEL I, NORMAL, AQL 1.5). A DEFLECTION INSPECTION FIXTURE IS USED TO VERIFY THE CENTERLINE OF THE SHEATH TO MEET THE APPLICABLE DEFLECTION CRITERIA. BEFORE THE SHEATH IS DEFLECTED, THE UNIT IS ENSURED THAT THE DISTAL TIP OF THE SHEATH IS ALIGNED WITH THE DISTAL ENGRAVED LINE OF THE TEMPLATE. FOR UNIDIRECTIONAL MODELS, VERIFY THE DEFLECTION KNOB IS SET TO 0. PLACE THE DEFLECTION SECTION OF THE DEVICE ON THE APPLICABLE TEMPLATE AS SHOWN IN FIGURES BELOW AND DEFLECT THE DEVICE UNTIL THE CURVE FALLS WITHIN THE APPLICABLE DEFLECTION TEMPLATE. VERIFY THE DEVICE CAN DEFLECT TO 170° (NOMINAL 180° - 10°) ON HALF THE TEMPLATE. THE INSTRUCTIONS FOR USE (IFU) INFORMS THE USER: PREPARING STEERABLE SHEATH FOR INSERTION: VERIFY DEFLECTING AND STRAIGHTENING OF THE DISTAL SECTION OF THE STEERABLE SHEATH USING THE HANDLE OF THE SHEATH. REFER TO DEFLECTING AND STRAIGHTENING THE STEERABLE SHEATH" FOR INSTRUCTIONS. GENERAL USE OF THE STEERABLE SHEATH: DO NOT FORCE THE STEERABLE SHEATH ASSEMBLY IF SIGNIFICANT RESISTANCE IS ENCOUNTERED DURING THE INSERTION OR PASSAGE. IF RESISTANCE IS ENCOUNTERED, DETERMINE THE CAUSE AND CORRECT BEFORE CONTINUING THE PROCEDURE. 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.
WHEN FLUSHING THE SHEATH WITH A SYRINGE, THERE IS LEAKING FROM THE SIDE OF THE VALVE. IN ADDITION, LATER IN THE PROCEDURE, WE COULD NOT PULL BACK THE BALLOON DEEP INTO THE SHEATH (IT GOT STUCK AROUND THE CURVE OF THE SHEATH). THE PHYSICIAN PUSHED THE BALLOON OUT OF THE SHEATH AND PULLED BACK AND THE SAME ISSUE. NO DEFLECTION ON THE SHEATH AND BALLOON WHEN DOING THESE MANEUVERS. THEN WE PUSHED THE BALLOON OUT AND INFLATED AND DEFLATED, BUT STILL IT GOT STUCK IN THE SAME POSITION. WE THEN PROCEEDED TO REMOVE BOTH THE SHEATH AND BALLOON FROM THE PATIENT AT THE SAME TIME. IT WAS REPORTED THERE WAS A 30 MINUTE PROCEDURE DELAY AND LOT NUMBER IS UNKNOWN. NO PATIENT CONSEQUENCES REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
THE CUSTOMER PROVIDED THE LOT NUMBER C819565 AND REPORTED THE PROCEDURE WAS SUCCESSFULLY COMPLETED WHEN THEY REMOVED THE SHEATH AND BALLOON FROM THE PATIENT AT THE SAME TIME. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1223850 | GUIDESTAR¿ STEERABLE GUIDING SHEATH | INTRODUCER, CATHETER | DYB | OSCOR INC. | D141101 | C819565 | 00885672009496 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |