FDA Adverse Event
Malfunction
Summary report: N
JAGWIRE
MDR report key: 1193262
·
Received October 7, 2008
Report
- Report Number
- 3005099803-2008-05081
- Event Type
- Malfunction
- Date Received
- October 7, 2008
- Date of Event
- September 9, 2008
- Report Date
- September 9, 2008
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- EZB
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION, THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE MANUFACTURING RECORD FOR THIS BATCH NUMBER SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPECIFICATIONS. THE ROOT CAUSE OF THE REPORTED EVEN COULD NOT BE DETERMINED.
Description of Event or Problem · 1
IT WAS REPORTED THAT UPON OPENING THE PACKAGE OF THE 0.035 JAGWIRE GUIDE WIRE, THERE WAS ONLY ONE GUIDE WIRE IN THE BOX WHEN THE BOX SHOULD HAVE CONTAINED TWO GUIDE WIRES. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | JAGWIRE | EZB | BOSTON SCIENTIFIC | M00556941 | 8591623 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |