FDA Adverse Event
Malfunction
Summary report: N
ZIPWIRE HYDROPHILIC GUIDE WIRE
MDR report key: 1023704
·
Received April 1, 2008
Report
- Report Number
- 2134265-2008-00932
- Event Type
- Malfunction
- Date Received
- April 1, 2008
- Date of Event
- February 28, 2008
- Report Date
- March 12, 2008
- Manufacturer
- BOSTON SCIENTIFIC
- Product Code
- DQX
- PMA / PMN Number
- K000011
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A HEMODIALATION CATHETER PLACEMENT PROCEDURE, THE GUIDE WIRE UNRAVELED. THE LESION WAS LOCATED IN THE SUBCLAVIAN ARTERY. THE ZIPWIRE UNRAVELED DURING INSERTION OF A HEMODIALYSIS CATHETER. ACCORDING TO THE CUSTOMER, IT LOOKED LIKE SPLINTERS COMING OFF THE END OF THE WIRE. NO PT COMPLICATIONS WERE REPORTED. PT STATUS IS REPORTED AS "FINE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZIPWIRE HYDROPHILIC GUIDE WIRE | DQX WIRE, GUIDE, CATHETER | DQX | BOSTON SCIENTIFIC | NA | 0001974923 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR |