FDA Adverse Event
Malfunction
Summary report: N
LAUNCHER 6F (LCB)
MDR report key: 2043094
·
Received March 15, 2011
Report
- Report Number
- 1220452-2011-00017
- Event Type
- Malfunction
- Date Received
- March 15, 2011
- Date of Event
- February 11, 2011
- Report Date
- February 25, 2011
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- DQY
- PMA / PMN Number
- K021256
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- 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. METHOD, CONCLUSION: OTHER.
Description of Event or Problem · 1
IT HAS BEEN REPORTED TO US THAT DURING THE PREPARATION OF THE GUIDE CATHETER, A HAIR LINE FRACTURE WAS NOTICED AT THE HUB. NO INJURY TO PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAUNCHER 6F (LCB) | DQY | MEDTRONIC, INC. | NA | 0004522370 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |