FDA Adverse Event
Malfunction
Summary report: N
GUARDWIRE PLUS 2-5RX-6F
MDR report key: 1065159
·
Received June 23, 2008
Report
- Report Number
- 1220452-2008-00047
- Event Type
- Malfunction
- Date Received
- June 23, 2008
- Date of Event
- June 6, 2008
- Report Date
- June 12, 2008
- Manufacturer
- MEDTRONIC INC.
- Product Code
- NFA
- PMA / PMN Number
- K013913
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- 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 PATIENT'S RIGHT CORONARY ARTERY. THE PHYSICIAN THEN INFLATED THE OCCLUSION BALLOON TO OCCLUDE THE VESSEL. BEFORE THE PHYSICIAN WAS ABLE TO PERFORM INTERVENTION ON THE VESSEL, THE PHYSICIAN NOTICED THAT THE OCCLUSION BALLOON HAD DEFLATED UNEXPECTEDLY. THE DEVICE WAS REMOVED AND REPLACED WITH ANOTHER TO COMPLETE THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GUARDWIRE PLUS 2-5RX-6F | NFA | MEDTRONIC INC. | NA | 0000637705 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |