OCCLUTECH DELIVERY SET III
Report
- Report Number
- 1035166-2025-00039
- Event Type
- Malfunction
- Date Received
- June 24, 2025
- Date of Event
- June 12, 2025
- Report Date
- September 15, 2025
- Manufacturer
- OSCOR INC.
- Product Code
- DYB
- UDI-DI
- 00885672010270
- PMA / PMN Number
- K210627
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- 003
Narratives
CONCLUSION NOT YET AVAILABLE, EVALUATION IN PROCESS. A FOLLOW-UP REPORT 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 FOLLOWING SECTIONS WERE UPDATED IN FOLLOW-UP 1. B4, D9, G3, G6, H2, H3, H6 & H11. THE SHEATH, DILATOR AND LOADER FROM A 9F OCCLUTECH DELIVERY SHEATH SET WAS RETURNED UNDER RMA# (B)(4). BLOOD WAS FOUND ON ALL COMPONENTS. A FRAGMENT FROM THE SHEATH WAS ALSO RETURNED IN A SEPARATE BAG. ACCORDING TO THE EVENT DESCRIPTION SUMMARY, DURING PATIENT CONTACT (DURING IMPLANTATION PROCESS) THE LOADER'S EXTREMITY DETACHED AND SHEATH'S TIP WITH A LITTLE PLASTIC FRAGMENT WAS FOUND DURING THE FLUSHING. UPON ASSESSMENT OF THE LOADER, IT WAS DETERMINED THAT THE DISTAL MOUNTING HUB MOVED VERTICALLY ALONG THE LOADER SHAFT RATHER THAN STAYING SECURELY ATTACHED - THE SHAFT WAS ALSO BENT. THE FRAGMENT THAT WAS RETURNED CAME FROM THE LINER INSIDE THE SHEATH SHAFT. THE SHEATH SHAFT'S ID WAS EVALUATED WITH A BORESCOPE, AND THE LINER WAS NOTED TO BE SMOOTH, WITH NO DAMAGE PRESENT THROUGHOUT ITS ENTIRE LENGTH. ALSO, THE TIP OF THE SHEATH INCLUDING THE LINER LOOKED NORMAL. FOLLOW LINER CUTTING INSTRUCTIONS PER MFG PROCEDURE (BREEZEWAY II SHAFT ASSEMBLY). PER QA PROCEDURE (BREEZEWAY II GUIDING SHEATH SHAFT ASSEMBLY) SAMPLE SIZE: ANSI / ASQ Z1.4 GENERAL LEVEL I, AQL 0.25, NORMAL. INSPECT THE SHAFT DISTAL TIP (LIGHT BLUE) TO ENSURE TIP HAS A RADIUS, THE LINER EXTENDS THROUGHOUT THE ENTIRE LENGTH OF THE DISTAL TIP AND THERE ARE NO DAMAGES (E.G. TAILS, UNEVEN CUTS). USING A BORESCOPE, INSPECT THE SHAFT INNER DIAMETER FOR TORN/DE-LAMINATED LINER AND EXPOSED BRAID. VERIFY THE PRESENCE OF THE GOLD MARKER BAND. SAMPLE SIZE: ANSI Z 1.4, GEN LEVEL 1, NORMAL, AQL 0.65 USING A BORESCOPE, INSPECT THE I.D. OF THE SHEATH TO ENSURE INNER LUMEN IS FREE OF ANY OBSTRUCTING MATERIAL. INSERT A ROUNDED PIN GAUGE OF THE APPROPRIATE FRENCH SIZE AND LENGTH INTO THE PROXIMAL END OF THE SHAFT AND THROUGH THE DISTAL TIP TO ENSURE CORRECT FIT AND NO OBSTRUCTIONS. PER MFG PROCEDURE (BREEZEWAY II LOADER HUB AND SIDEPORT GLUING AND UV CURING PROCESS) APPLY THE ADHESIVE BETWEEN THE SPACE OF THE ID OF THE DISTAL HUB AND THE LOADER TUBE OD BY PRESSING DOWN ON THE PEDAL OF THE EFD UNIT. IMPORTANT: ENSURE THE GLUE JOINT DOES NOT CONTAIN AIR BUBBLES OR AIR POCKETS. CAREFULLY TAKE THE DISTAL HUB HOLDING FIXTURE WITH THE UNITS TO THE UV CURING SYSTEM AND CURE JUNCTION OF TUBE AND THE HUB. AFTER CURING, TEST THE JOINT OF EACH PART WITH A SMALL TUG, HOLDING THE TUBE IN ONE HAND AND THE HUB IN THE OTHER HAND. PER QA PROCEDURE (BREEZEWAY II LOADER IN-PROCESS AND FINAL INSPECTION) SAMPLE SIZE: FOR NON-DESTRUCTIVE TESTING, INSPECT FIRST 5 GOOD PARTS AND LAST 5 PARTS OF THE LOT. REMAINING LOT QUANTITY TO BE INSPECTED ACCORDING TO ANSI Z 1.4, GEN LEVEL 1, NORMAL, AQL 0.65. WITH UNAIDED VISION AT 12" - 18", INSPECT THE HUB GLUE JOINTS FOR BUBBLES OR AIR POCKETS. GLUE JOINTS SHALL NOT HAVE ANY VISIBLE BUBBLES OR POCKETS OF AIR. SAMPLE SIZE: FIRST 5 GOOD SHOTS AND 5 LAST SHOTS OF THE LOT, INSPECT 100% PULL ON THE HUB AND THE LOADER VERIFYING PROPER ATTACHMENT WITHOUT DAMAGING LOADER WHILE PULLING. REJECT IF THE HUB IS LOOSE FROM THE LOADER. PULL TEST (DESTRUCTIVE TEST). SAMPLE SIZE: FOR DESTRUCTIVE TESTING, TEST PER S-4 SAMPLING LEVEL AQL = 1.0, REDUCED. USING A TENSILE TESTER, A LOADER HUB HOLDING FIXTURE AND/OR CLAMP, PERFORM THE TEST TO EVALUATE THE BOND STRENGTH BETWEEN THE LOADER TUBE AND DISTAL HUB AS PER PROCEDURE. BOND STRENGTH SHALL BE [?] 15 N (3.37 LBF). IFU IS PROVIDED WITH THIS PRODUCT. RETURNED DEVICE ANALYSIS REVEALED A FRAGMENT OF THE SHEATH'S LINER BECAME DETACHED AND THE DISTAL MOUNTING HUB OF THE LOADER BECAME DETACHED FROM THE LOADER SHAFT. SINCE NO DAMAGE OR TORN LINER WAS FOUND WHEN THE ID OF THE SHEATH WAS INSPECTED WITH A BORESCOPE, THE FRAGMENT OF LINER COULD HAVE HAPPENED DURING THE CUTTING STEP TO REMOVE EXCESS LINER AT THE END OF THE SHEATH BECAUSE THAT PART CAN ACCORDION AND COULD POTENTIALLY INVERT ITSELF IN THE ID WHEN IT HITS THE DE-CORING TOOL IF NOT REMOVED. THE LOADERS UNDERGO A VISUAL INSPECTION TO ENSURE THE CORRECT APPLICATION OF GLUE AND ARE SUBJECTED TO TUG TESTING 100% DURING THE MANUFACTURING PROCESS, AS WELL AS BY QA AT AN AQL LEVEL. IN CONCLUSION, THE REVIEW OF THE DHR DID NOT IDENTIFY ANY MANUFACTURING ANOMALIES OF THIS TYPE AND PASSED ALL FINAL TESTING PRIOR TO SHIPMENT. THE STATED FAILURE OF THE RETURNED PRODUCT WAS CONFIRMED BY OUR INVESTIGATION. CAPA 06152 WAS OPENED TO INVESTIGATE THE ROOT CAUSE OF THE LOADER MOUNT DETACHMENT AND IMPLEMENT CORRECTIVE ACTION TO PREVENT RECURRENCE OF THIS ISSUE. THE STATED FAILURE OF THE FRAGMENT EXPELLED DURING FLUSHING THE SHEATH WAS CONFIRMED BY OUR INVESTIGATION AND MANUFACTURING OPERATIONS HAVE BEEN ADVISED OF THE REPORTED COMPLAINT. 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 FOLLOWING SECTIONS WERE UPDATED IN FOLLOW-UP 2. B4, G3, G6, H2, H3, H6 & H11. H2: CORRECTIONS B5: REMOVED THE FOLLOWING STATEMENT FROM B5 IN INITIAL REPORT (NOTE: SKIVING IS NOT A MANUFACTURING DEFECT). SKIVING IS A KNOW MANUFACTURING DEFECT). H6: CORRECTED THE MEDICAL DEVICE PROBLEM CODE FROM 4118 (INITIAL) TO 2915 (FU 2) DEVICE DAMAGED BY ANOTHER DEVICE. 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 CUSTOMER REPORTED THAT DURING PATIENT CONTACT (DURING IMPLANTATION PROCESS) THE LOADER'S EXTREMITY DETACHED + SHEATH'S TIP WITH A LITTLE PLASTIC FRAGMENT FOUND DURING THE FLUSHING. I TOOK THE DEFECTIVE PRODUCTS (SHEATH WITH PLASTIC FRAGMENT + LOADER) TO SEND THEM FOR EXPERTISE. THE DEVICE WAS INSPECTED PRIOR TO USE; HOWEVER, IT'S NOTED THERE WAS A DEVIATION DURING THE INSPECTION. THERE WAS NO PRE-EXISTING CONDITION RELEVANT TO THE EVENT. PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO OTHER DEVICE USED TO COMPLETE THE PROCEDURE. THE CUSTOMER STATES THE REPORTED ISSUE WAS CLINICALLY SIGNIFICANT EXTENDED TREATMENT OR PROCEDURE TIME AND COULD HAVE BEEN VERY SERIOUS. THE DEVICE WILL BE RETURNED. 24/JUN/2025 CLARIFICATION OF EVENT RECEIVED: THE PROCEDURE WAS COMPLETED SUCCESSFULLY, AND NO OTHER DEVICE WAS USED BUT THE PATIENT WAS INVOLVED, SORRY FOR THE MISUNDERSTANDING. WE FOUND A LITTLE BLUE PLASTIC FRAGMENT PROVIDED FROM THE SHEATH DURING THE FLUSHING. YOU HAVE TO CONSIDER 2 DIFFERENT PROBLEMS: THE FIRST ONE WAS THE LITTLE PLASTIC FRAGMENT FROM THE SHEATH FOUND DURING THE FLUSHING, AND THE SECOND ONE WAS THE GLUING PROBLEM CONCERNING THE LOADER. FOR THE FIRST PROBLEM (BLUE PLASTIC FRAGMENT) THEY CONSIDERED THAT, AS THE FLUSHING WAS REALLY GOOD AND NO OTHER FRAGMENTS APPEARED THEN IT WASN'T DANGEROUS FOR THE PATIENT. FOR THE SECOND PROBLEM, THE LOADER'S EXTREMITY CAME OFF / UNSTUCK DURING THE PROCEDURE AND THEY CONSIDERED THAT IT WAS PREFERABLE TO CONTINUE THE PROCEDURE RATHER THAN BRING OUT THE SHEATH FROM THE BODY AND START AGAIN THE PROCEDURE. THERE WAS A 2-3-MINUTE PROCEDURE DELAY. THERE WAS NO MEDICAL INTERVENTION. THE PRODUCT WILL BE SENT FOR AN EXPERTISE. NOTE: SKIVING IS NOT A MANUFACTURING DEFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1568250 | OCCLUTECH DELIVERY SET III | INTRODUCER, CATHETER | DYB | OSCOR INC. | 98DS009 | DP-19889 | 00885672010270 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Female |