FDA Adverse Event
Malfunction
Summary report: N
SPRINTER OTW BALLOON DILATATION CATHETER
MDR report key: 1934361
·
Received November 24, 2010
Report
- Report Number
- 2953200-2010-02325
- Event Type
- Malfunction
- Date Received
- November 24, 2010
- Date of Event
- October 28, 2010
- Report Date
- October 29, 2010
- Manufacturer
- MEDTRONIC CARDIOVASCULAR GALWAY
- Product Code
- LOX
- PMA / PMN Number
- P790017
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVAL: RESULTS: OTHER (NO ROOT CAUSE OF THE EVENT CAN BE DETERMINED BASED ON INFO AVAILABLE).
Description of Event or Problem · 1
AN ATTEMPT WAS MADE TO USE A 1.5MM DIAMETER X 6MM LENGTH SPRINTER OVER THE WIRE (OTW) BALLOON DILATATION CATHETER TO PRE DILATE A LESION LOCATED IN THE LAD TO DIAGONAL DESCRIBED AS TORTUOUS AND CALCIFIED. NO ABNORMALITIES WERE NOTED DURING PREPARATION AND INSPECTION OF THE DEVICE PRIOR TO USE; HOWEVER, IT WAS REPORTED THAT DIFFICULTIES WERE EXPERIENCED BY THE PHYSICIAN IN MANEUVERING THE DEVICE AND THE BALLOON FAILED TO BE INFLATED. THE PROCEDURE WAS COMPLETED WITH A NEW BALLOON DILATATION CATHETER. NO OTHER CLINICAL SEQUELAE WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINTER OTW BALLOON DILATATION CATHETER | LOX | MEDTRONIC CARDIOVASCULAR GALWAY | NA | 0004521266 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |