MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2006-07-31 for GILASITE RADIATION THERAPY SYSTEM (RTS) * 1030 manufactured by Cytyc Surgical Products.
[17436838]
It was reported that the gliasite baloon catheter wa explanted and iotrex radiotherapy solution was retrieved 29 hours prior to the completion of brachytherapy. It was reported that the patient was implanted with the gliasite catheter 3/10/2005. Patient was admitted to hospital 03/20/2005 after diagnosis of sepsis due to infection. Patient evaluated by neurosurgeon and radiation oncologist (ro). Ro reported radiation in the bladder. On 03/21/2005, device was explanted and iotrex was retrieved in the operating room under anesthesia because of patient discomfort caused by the infection. Iotrex was retrieved at 6:15pm; however, radiation was not recorded in the bladder at 4:30pm post-retrieval.
Patient Sequence No: 1, Text Type: D, B5
[17660187]
Lot history record reviewed - no evidence of product sterilization issues. Device was not returned for evaluation. Infection is an anticipated adverse event associated with cranial brachytherapy.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1067103-2006-00004 |
| MDR Report Key | 744160 |
| Report Source | 05 |
| Date Received | 2006-07-31 |
| Date of Report | 2005-03-21 |
| Date of Event | 2005-03-21 |
| Date Mfgr Received | 2005-03-21 |
| Date Added to Maude | 2006-08-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Street | 1047 ELWELL COURT |
| Manufacturer City | PALO ALTO, CA 94303 |
| Manufacturer Country | US |
| Manufacturer Postal | 94303 |
| Manufacturer Phone | 6503352603 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GILASITE RADIATION THERAPY SYSTEM (RTS) |
| Generic Name | MANUAL RADIONUCLIDE APPLICATOR |
| Product Code | IWJ |
| Date Received | 2006-07-31 |
| Model Number | * |
| Catalog Number | 1030 |
| Lot Number | M22417 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 731957 |
| Manufacturer | CYTYC SURGICAL PRODUCTS |
| Manufacturer Address | 1047 ELWELL COURT. PALO ALTO, CA 94303 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2006-07-31 |