FDA Adverse Event
Malfunction
Summary report: N
SPRINTER LEGEND RX BALLOON DILATATION CATHETER
MDR report key: 2060778
·
Received March 10, 2011
Report
- Report Number
- 9612164-2011-00039
- Event Type
- Malfunction
- Date Received
- March 10, 2011
- Date of Event
- February 11, 2011
- Report Date
- February 11, 2011
- Manufacturer
- MEDTRONIC MEXICO
- Product Code
- LOX
- PMA / PMN Number
- P790017
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - (NO CONCLUSION CAN BE DRAWN). (NO DEVICE REC'D FOR EVALUATION).
Description of Event or Problem · 1
A 2.5MM DIAMETER X 12M LENGTH SPRINTER RAPID EXCHANGE (RX) WAS REPORTED TO HAVE INFLATED SLOWLY AND DID NOT DEFLATE COMPLETELY. NO HEALTH HAZARD WAS CAUSED TO THE PT AND NO OTHER CLINICAL SEQUELAE WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINTER LEGEND RX BALLOON DILATATION CATHETER | LOX | MEDTRONIC MEXICO | NA | 11019724 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |