FDA Adverse Event
Malfunction
Summary report: N
GUARDWIRE PLUS OCCLUSION DEVICE-JAPAN
MDR report key: 929837
·
Received April 3, 2007
Report
- Report Number
- 1220452-2007-00021
- Event Type
- Malfunction
- Date Received
- April 3, 2007
- Date of Event
- March 26, 2007
- Report Date
- March 26, 2007
- Manufacturer
- MEDTRONIC VASCULAR
- Product Code
- NFA
- PMA / PMN Number
- k023878
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVAL IS ANTICIPATED UPON RECEIPT OF THE DISCREPANT DEVICE. AN ENGINEERING ANALYSIS OF THE SUBJECT DEVICE WILL BE PERFORMED UPON RECEIPT. DEVICE EVAL ANTICIPATED, BUT NOT YET BEGUN.
Description of Event or Problem · 1
IT HAS BEEN REPORTED TO US THAT DURING THE PROCEDURE THE OCCLUSION BALLOON DEFLATED UNEXPECTEDLY. THE PHYSICIAN INSERTED THE OCCLUSION BALLOON WIRE INTO THE PT AND INFLATED THE OCCLUSION BALOOON TO 5MM TO OCCLUDE THE VESSEL. THE PHYSICIAN THEN NOTICED THAT THE OCCLUSION BALLOON HAD DEFLATED UNEXPECTEDLY. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER TO COMPLETE THE CASE. THE PT IS REPORTED TO BE FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUARDWIRE PLUS OCCLUSION DEVICE-JAPAN | NFA | NFA | MEDTRONIC VASCULAR | NA | 0000319658 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |