FDA Adverse Event
Malfunction
Summary report: N
SIR-SPHERES MICROSPHERES
MDR report key: 18788562
·
Received February 27, 2024
Report
- Report Number
- 9710358-2024-00001
- Event Type
- Malfunction
- Date Received
- February 27, 2024
- Date of Event
- November 17, 2022
- Report Date
- February 27, 2024
- Manufacturer
- SIRTEX MEDICAL PTY LIMITED
- Product Code
- NAW
- UDI-DI
- M425SIRY0010
- PMA / PMN Number
- P990065
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE BATCH REVIEW AND MANUFACTURING RECORDS DID NOT REVEAL ANY MANUFACTURING ISSUES WITH THE SIR-SPHERES. THE DEVICE WAS NOT RETURNED FOR INVESTIGATION. THIS INCIDENT WAS INITIALLY ASSESSED AS A NON-REPORTABLE EVENT. A SECOND REVIEW THAT WAS RECENTLY CONDUCTED, CONCLUDED THAT THIS EVENT SHOULD HAVE BEEN REPORTED.
Description of Event or Problem · 0
PROCEDURE INCLUDED A SEGMENTAL DELIVERY WITH MULTIPLE ALIQUOTS. EVERYTHING PRIOR AND DURING THE PROCEDURE LOOKED NORMAL. WHEN THE POST PROCEDURE 4 POINT SURVEY WAS DONE THE HEALTHCARE PROFESSIONAL REALIZED THAT ONLY 40% OF THE PRESCRIBED DOSE WAS DELIVERED TO THE PATIENT. NO FURTHER INFORMATION HAVE BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 110055 | SIR-SPHERES MICROSPHERES | Y90 RESIN MICROSPHERES | NAW | SIRTEX MEDICAL PTY LIMITED | SIR-Y001 | 0K029V14 | M425SIRY0010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |