FDA Adverse Event
Injury
Summary report: N
8F ZUMA JCL4.5
MDR report key: 217971
·
Received April 7, 1999
Report
- Report Number
- 1220452-1999-00012
- Event Type
- Injury
- Date Received
- April 7, 1999
- Date of Event
- March 18, 1999
- Report Date
- March 18, 1999
- Manufacturer
- MEDTRONIC INTERVENTIONAL VASCULAR, INC
- Product Code
- DYB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, 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 THE LEFT CIRCUMFLEX ARTERY IN WHICH TWO LESIONS WERE LOCATED, AS HE PROCEEDED TO PLACE THE PROXIMAL STENT A DISSECTION OF THE LEFT MAIN CORONARY ARTERY OCCURRED. THE PATIENT WAS TAKEN TO BYPASS SURGERY AND THE STATUS OF THE PATIENT WAS UNKNOWN AT THE TIME OF THIS REPORT. 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 JCL4.5 | GUIDING CATHETER | DYB | MEDTRONIC INTERVENTIONAL VASCULAR, INC | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |