FDA Adverse Event
Injury
Summary report: N
8F ZUMA JR40
MDR report key: 217986
·
Received April 7, 1999
Report
- Report Number
- 1220452-1999-00019
- Event Type
- Injury
- Date Received
- April 7, 1999
- Date of Event
- March 11, 1999
- Report Date
- March 17, 1999
- Manufacturer
- MEDTRONIC INTERVENTIONAL VASCULAR, INC
- Product Code
- DYB
- Removal / Correction Number
- NA
- Adverse Event
- 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 LESION, AS THE GUIDE CATHETER PROCEEDED TO INTUBATE THE ARTERY A SPIRAL DISSECTION ORIGINATING AT THE OSTIUM REPORTEDLY WAS OBSERVED. THE PLACEMENT OF THREE STENTS WAS REQUIRED TO CONTROL THE DISSECTION. 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 | Required Intervention |