FDA Adverse Event
Malfunction
Summary report: N
STABILIZER PLUS
MDR report key: 958992
·
Received December 3, 2007
Report
- Report Number
- 1016427-2007-00126
- Event Type
- Malfunction
- Date Received
- December 3, 2007
- Date of Event
- November 5, 2007
- Report Date
- November 7, 2007
- Manufacturer
- CORDIS CORPORATION
- Product Code
- DQX
- PMA / PMN Number
- K873403
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.
Description of Event or Problem · 1
THE SGW STABILIZER PLUS WIRE DID NOT COIL COMPLETELY AT THE CONNECTION OF THE SHAPE SECTION AND THE TIP SECTION (WAS NOT WRAPPED BY THE STEEL WIRE). THIS WAS NOTICED AFTER THE WIRE WAS REMOVED FROM THE PACKAGE. THE WIRE WAS REMOVED FROM THE DISTAL END. THE PACKAGE WAS INTACT BEFORE IT WAS OPENED. THE PRODUCT WAS NOT CLINICALLY USED IN THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | STABILIZER PLUS | CARDIOLOGY WIRES & METALS (DQX) | DQX | CORDIS CORPORATION | NA | 71206736 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR |