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 GLIASITE RADIATION THERAPY SYSTEM (RTS) * 1030 manufactured by Cytyc Surgical Products.
[523751]
It was reported that the gliasite balloon catheter was explanted and iotrex radiotherapy solution was retrieved 29 hrs prior to the completion of brachytherapy. It was reported that the pt was implanted with the gliasite catheter in 2005. Pt was admitted to hosp 10 days after diagnosis of sepsis due to infection. Pt evaluated by neurosurgeon and radiation oncologist (ro). Ro reported radiation in the bladder. On the following day, device was explanted and iotrex was retrieved in the operating room under anesthesia because of pt 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
[7789736]
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. Cytyc surgical products is resubmitting mdr form 3500a to correct typographical error in the mfr report # 1067103-2005-00006. Form 3500a was submitted to fda on 8/29/05. The event, narrative and conclusion does not change. The correction being submitted is the mfr report # on page 1 of form 3500 a.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1067103-2005-00006 |
| MDR Report Key | 748648 |
| 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 | 2006-08-16 |
| 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 | GLIASITE 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 | 736426 |
| Manufacturer | CYTYC SURGICAL PRODUCTS |
| Manufacturer Address | 1047 ELWELL CT PALO ALTO CA 94303 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Other; 3. Required No Informationntervention | 2006-07-31 |