MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2009-03-20 for FLEXI-GUIDE NEEDLE 15.5 GAUGE 9807GM15-5-20 9807GM15.5-20 manufactured by Mick Radio-nuclear Instruments, Inc.
[1195347]
Pt was administered an hdr prostate treatment using an afterloader attached to flexi-guide needles. The treatment called for 17 needles to be imbedded in the prostate, locked in place through a template grid and connected to the afterloader via fixed length transfer tubes. The needles accept a radioactive source wire driven out from the afterloader to administer a pre-planned dosage to the pt. Three treatment fractions were planned. Standard protocol called for the following: a dummy source wire is run through all transfer tubes in sequence into the respective needle to ensure no obstructions and to check for the proper length. After a successful dry run, the dummy wire is run through again to determine the proper depth. After this verification, the active source wire is run out and the dosage is administered. The needles were implanted according to plan and the first treatment fraction was administered on (b)(6)09 without incident. The needles remained in the pt overnight with a protective cone attached to protect the needles from becoming disturbed. The second fraction was administered in the morning of (b)(6)09. The dummy wire run for channels 1-17 was successfully completed and treatment commenced. Channels 1, 2 & 3 were completed without incident. Channel 4 was interrupted by a machine error message indicating the wire was too long for the channel. When the dummy wire was retracted there was blood present in the transfer tube. The physicist stopped treatment to call the manufacturer of the afterloader who assisted in planning the completion of the treatment. Treatment commenced for channels 5-17. Since the afterloader transfer tubes and source wire were contaminated with blood the final fraction scheduled for later the same day was aborted. When the needles were removed from the pt, it was discovered that the needle in channel 4 was missing the tip with allowed the blood to enter the system. The pt was subsequently sent home and is scheduled for the final treatment fraction on (b)(6)09.
Patient Sequence No: 1, Text Type: D, B5
[8145832]
This is the first reportable incident involving the flexi-guide product.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2431392-2009-00001 |
| MDR Report Key | 1387747 |
| Report Source | 05 |
| Date Received | 2009-03-20 |
| Date Mfgr Received | 2009-03-13 |
| Device Manufacturer Date | 2007-06-01 |
| Date Added to Maude | 2010-02-02 |
| 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 | 521 HOMESTEAD AVE. |
| Manufacturer City | MOUNT VERNON NY 10550 |
| Manufacturer Country | US |
| Manufacturer Postal | 10550 |
| Manufacturer Phone | 9146673999 |
| Single Use | 3 |
| Remedial Action | RL |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXI-GUIDE NEEDLE 15.5 GAUGE |
| Generic Name | HDR PROSTATE NEEDLE |
| Product Code | IWJ |
| Date Received | 2009-03-20 |
| Returned To Mfg | 2009-03-20 |
| Model Number | 9807GM15-5-20 |
| Catalog Number | 9807GM15.5-20 |
| Lot Number | M2007-093 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MICK RADIO-NUCLEAR INSTRUMENTS, INC |
| Manufacturer Address | 521 HOMESTEAD AVE. MOUNT VERNON NY 10550 US 10550 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-03-20 |