FDA Adverse Event
Malfunction
Summary report: N
NEUROFORM 3 MICRODELIVERY STENT SYSTEM
MDR report key: 851876
·
Received May 15, 2007
Report
- Report Number
- 6000078-2007-00132
- Event Type
- Malfunction
- Date Received
- May 15, 2007
- Date of Event
- April 16, 2007
- Report Date
- April 16, 2007
- Manufacturer
- BOSTON SCIENTIFIC/ NEUROVASCULAR DIVISION
- Product Code
- NJE
- PMA / PMN Number
- H020002/S4
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER, THE INVESTIGATION IS IN PROGRESS. ADD'L PMA/510(K) # H020002/S5.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE PROCEDURE, THE DELIVERY CATHETER (THE DEVICE IN QUESTION) SPLIT INTO TWO PIECES APPROXIMATELY 1 TO 10 INCHES FROM THE HUB OF THE MICRO CATHETER WHILST THE PHYSICIAN WAS ATTEMPTING TO DEPLOY THE STENT. THE PHYSICIAN REMOVED THE DEVICE AND COMPLETED THE PROCEDURE USING A SECOND DEVICE. NO PATIENT COMPLICATIONS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NEUROFORM 3 MICRODELIVERY STENT SYSTEM | INTRACRANIAL STENT | NJE | BOSTON SCIENTIFIC/ NEUROVASCULAR DIVISION | SNF33020 | 9390431 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR |