FDA Adverse Event
Malfunction
Summary report: N
ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM
MDR report key: 1234063
·
Received November 4, 2008
Report
- Report Number
- 1058196-2008-00261
- Event Type
- Malfunction
- Date Received
- November 4, 2008
- Date of Event
- October 7, 2008
- Report Date
- October 7, 2008
- Manufacturer
- CORDIS NEUROVASCULAR, INC.
- Product Code
- NJE
- PMA / PMN Number
- H60001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING, HOWEVER, THE ENGINEERING EVALUATION IS NOT YET COMPLETE. THIS IS ONE OF TWO PRODUCTS USED ON THE SAME PATIENT. MFR REPORT # 1058196-2008-00261, MFR REPORT # 1058196-2008-00262. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.
Description of Event or Problem · 1
DURING THE ENTERPRISE STENT PLACEMENT, THE SYSTEM GOT STUCK INSIDE PROWLER MICROCATHETER (MC) AND COULD NOT ADVANCE OR RETRACT STENT. ALL OF THE GUIDELINES TO PREP AND FLUSH THE STENT WERE FOLLOWED. THE PHYSICIAN DID FEEL SOME INITIAL FRICTION UPON ADVANCING THE STENT, BUT THE STENT DID ADVANCE EASILY AFTER THAT. THE STENT GOT STUCK AT THE DISTAL TIP OF THE MC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERPRISE VASCULAR RECONSTRUCTION DEVICE AND DELIVERY SYSTEM | CNV ENTERPRISE SES (NJE) | NJE | CORDIS NEUROVASCULAR, INC. | NA | 13413563 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |