ANGIODYNAMICS SAFESHEATH® ULTRA LITE
Report
- Report Number
- 1035166-2025-00012
- Event Type
- Malfunction
- Date Received
- March 19, 2025
- Date of Event
- February 13, 2025
- Report Date
- November 3, 2025
- Manufacturer
- OSCOR INC.
- Product Code
- DYB
- UDI-DI
- 25051684026298
- PMA / PMN Number
- K073100
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, 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. 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 HAVE NOT 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, G3, G6, H2, H3, H6, AND H11 THE DILATOR FROM A 10F ANGIODYNAMICS SAFESHEATH ULTRA LITE INTRODUCER SHEATH KIT WAS RETURNED UNDER RMA # 1202108199. THERE WERE NO OTHER ACCESSORIES. THE HUB WAS DETACHED FROM THE DILATOR SHAFT. TRACES OF BLOOD WERE FOUND ON AND INSIDE THE DILATOR. ACCORDING TO THE EVENT DESCRIPTION SUMMARY, THE HUB SEPARATED FROM THE DILATOR, LEAVING IT RETAINED INSIDE THE PEEL AWAY. UPON RECEIPT OF THE PRODUCT, IT WAS FOUND THE HUB WAS DETACHED FROM THE DILATOR SHAFT. DURING THE INVESTIGATION OF THE NON-CONFORMITY, THE UNIT WAS THOROUGHLY EVALUATED. IT WAS OBSERVED THAT THE HUB HAD COMPLETELY DETACHED FROM THE DILATOR TUBE, LEAVING NO RESIN RESIDUES BEHIND. ADDITIONALLY, IT WAS EVIDENT THAT THE SECTION OF THE TUBE INSIDE THE DILATOR WAS RELATIVELY SHORT. ACCORDING TO MANUFACTURING THERMOPLASTIC OVERMOLDING OF PARTS PROCEDURE, THE TUBE MUST BE INSERTED UP TO THE CORE PIN MARK WITHOUT COVERING IT. UPON REPLICATING THE DEFECT, WE FOUND THAT IF THE TUBE IS NOT CORRECTLY INSERTED INTO THE CORE PIN UP TO THE INDICATED LINE, THE HUB IS NOT OVERMOLDED WITH SUFFICIENT GRIP ON THE TUBE, LEADING TO ITS DETACHMENT. A REVIEW OF THE MOLDING PARAMETERS RECORDED IN THE WORK ORDERS WAS CONDUCTED. IT WAS CONFIRMED THAT ALL PARAMETERS WERE WITHIN THE ESTABLISHED SPECIFICATIONS. A REVIEW OF THE MATERIALS USED IN THE PRODUCTION PROCESS WAS CONDUCTED. IT WAS CONFIRMED THAT ALL MATERIALS USED CORRECTLY CORRESPOND TO THOSE SPECIFIED IN THE BILL OF MATERIALS (BOM). MANUFACTURING PROCEDURE THERMOPLASTIC OVERMOLDING OF PARTS: · MAKE SURE TO INSERT THE TUBE UNTIL THE MARK IN THE CORE PIN WITHOUT COVERING IT. · INTRODUCE THE TUBE UNTIL THE MARK SHOWED IN THE CORE PIN TO THE CORRECT ASSEMBLY INTO THE CORE PIN BEFORE OVERMOLDING. · IF NECESSARY, CUT THE PARTS TO LENGTH, AS PER THE APPROVED PRODUCT SPECIFICATION. QA PROCEDURE ADELANTE-S INTRODUCER DILATOR IN PROCESS AND FINAL INSPECTION: · OVERMOLDED DILATOR: FIRST 5 GOOD SHOTS AND LAST 5 SHOTS (ENSURE ALL CAVITIES FROM MOLD FOR FIRST 5 AND LAST 5 SHOTS). · PERFORM THE INTRODUCER BOND STRENGTH TEST ACCORDING TO PROCEDURE "INTRODUCER BOND STRENGTH TEST" AND DOCUMENT ON "ADELANTE-S INTRODUCER DILATOR OVERMOLDING INSPECTION RECORD". REGISTER THE INSPECTION RESULTS INTO THE ADELANTE-S INTRODUCER DILATOR OVERMOLDING INSPECTION RECORD. THE SSU LITE INSTRUCTIONS FOR USE (IFU) IS INCLUDED WITH THIS PRODUCT. RETURNED DEVICE ANALYSIS REVEALED THE CAUSE OF DILATOR HUB DETACHMENT WAS RELATED TO THE PROCEDURE NOT BEING FOLLOWED CORRECTLY. PROCEDURES WILL BE REVISED TO PREVENT RECURRENCE OF THIS ISSUE. AFTER THE PROCEDURE UPDATE, THE APPROPRIATE PERSONNEL WILL BE TRAINED ON THEIR RESPECTIVE PROCEDURES. IN CONCLUSION, THE REVIEW OF THE DEVICE HISTORY RECORDS 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. 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.
AN END USER REPORTED HAVING AN ISSUE WITH THE INTRODUCER DURING A PROCEDURE. AFTER THE PEEL AWAY DILATOR WAS INSERTED AND UPON REMOVAL THE HUB SEPARATED FROM THE DILATOR, LEAVING IT RETAINED INSIDE THE PEEL AWAY. THIS WAS IMMEDIATELY NOTED BY THE SCRUB TECH, WHO THEN ALERTED THE PHYSICIAN, AND THE FRAGMENTED DEVICE WAS REMOVED, WITHOUT INCIDENT. THE FOLLOWING PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. (B)(6) /2025, THE ISSUE WAS FOUND DURING A RIGHT HEART CATHETERIZATION AND PORT IMPLANT PROCEDURE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS, HARM, OR REQUIRE MEDICAL INTERVENTION BECAUSE OF THIS INCIDENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 621071 | ANGIODYNAMICS SAFESHEATH® ULTRA LITE | INTRODUCER, CATHETER | DYB | OSCOR INC. | VI10 | S9311809 | 25051684026298 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |