FDA Adverse Event
Malfunction
Summary report: N
8F ZUMA JR40
MDR report key: 217966
·
Received April 7, 1999
Report
- Report Number
- 1220452-1999-00011
- Event Type
- Malfunction
- Date Received
- April 7, 1999
- Date of Event
- March 9, 1999
- Report Date
- March 17, 1999
- Manufacturer
- MEDTRONIC INTERVENTIONAL VASCULAR, INC
- Product Code
- DYB
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT HAS BEEN REPORTED TO THE CO THAT DURING A PROCEDURE IN WHICH THE PHYSICIAN ATTEMPTED TO DILATE A MID RIGHT CORONARY TOTAL OCCLUSION, AS THE GUIDE CATHETER WAS BEING REPOSITIONED AN OSTIAL DISSECTION OCCURRED. THE DISSECTION SPIRALED DOWN TO THE DISTAL AREA. NO MEDICAL OR SURGICAL INTERVENTION WAS REQUIRED. THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. THE DEVICE IS NOT BEING RETURNED FOR EVALUATION AS IT HAS BEEN DISCARDED BY THE HOSPITAL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 8F ZUMA JR40 | GUIDING CATHETER | DYB | MEDTRONIC INTERVENTIONAL VASCULAR, INC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |