FDA Adverse Event
Malfunction
Summary report: N
PROWLER SELECT MICROCATHETERS
MDR report key: 1234064
·
Received November 4, 2008
Report
- Report Number
- 1058196-2008-00262
- 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
- KRA
- PMA / PMN Number
- K021591
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE PRODUCT IS TO BE RETURNED FOR EVALUATION AND TESTING. THIS IS ONE OF TWO PRODUCTS USED ON THE SAME PATIENT. MFR REPORT #1058196-2008-00261 AND 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 | PROWLER SELECT MICROCATHETERS | CES MICROCATHETERS | KRA | CORDIS NEUROVASCULAR, INC. |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |