MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-03-22 for SIR-SPHERES Y-90 RESIN MICROSPHERES DELIVERY SYSTEM N/A SIR-K002 manufactured by Sirtex Medical Limited.
[40913387]
Patient Sequence No: 1, Text Type: N, H10
[40913388]
Patient was scheduled for selective internal radiation therapy (sirt) for liver tumor. During procedure it was noticed that there was a leakage on the membrane of the v vial after first injection. Attempt was made to seal the leak but to no avail. The decision was made to abort the procedure due to possible exposure to staff, patient, and procedure room. All possible exposure areas were scanned by physicist and there appeared to be no exposure. The delivery box and all contaminated materials were put into a red bag. It is estimated that patient received less than 10% of the prescribed dose. Radiation oncologist spoke with patient and procedure will be rescheduled. No patient harm identified as a result. Manufacturer response for selective internal radiation therapy (sirt) - v vial, sir-spheres y-90 resin microspheres delivery system (per site reporter): placing derma bond to the v-vial before administration of the dose in order to prevent any possibility of leakage.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5517553 |
| MDR Report Key | 5517553 |
| Date Received | 2016-03-22 |
| Date of Report | 2015-11-04 |
| Date of Event | 2015-10-30 |
| Report Date | 2015-11-04 |
| Date Reported to FDA | 2015-11-04 |
| Date Reported to Mfgr | 2015-11-04 |
| Date Added to Maude | 2016-03-22 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SIR-SPHERES Y-90 RESIN MICROSPHERES DELIVERY SYSTEM |
| Generic Name | SYSTEM, APPLICATOR, RADIONUCLIDE, MANUAL |
| Product Code | IWJ |
| Date Received | 2016-03-22 |
| Model Number | N/A |
| Catalog Number | SIR-K002 |
| Lot Number | 081521 |
| ID Number | N/A |
| Device Expiration Date | 2018-08-31 |
| Device Availability | Y |
| Device Age | 1 DY |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIRTEX MEDICAL LIMITED |
| Manufacturer Address | 16 UPTON DRIVE, #2-4 WILMINGTON MA 01887 US 01887 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-03-22 |