FDA Adverse Event
Injury
Summary report: N
8F ZUMA JR40
MDR report key: 217978
·
Received April 7, 1999
Report
- Report Number
- 1220452-1999-00014
- Event Type
- Injury
- Date Received
- April 7, 1999
- Date of Event
- March 24, 1999
- Report Date
- March 25, 1999
- Manufacturer
- MEDTRONIC INTERVENTIONAL VASCULAR, INC
- Product Code
- DYB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT HAS BEEN REPORTED TO THE CO THAT DURING THE PROCEDURE AS THE PHYSICIAN ATTEMPTED TO SEAT THE CATHETER A DISSECTION OF THE PT'S VESSEL REPORTEDLY OCCURRED. IT IS STATED TO HAVE BEEN A SPIRAL DISSECTION REQUIRING THE PLACEMENT OF TWO STENTS FOR REPAIR. THE PATIENT IS REPORTED TO BE FINE WITH NO FURTHER COMPLICATIONS REPORTED. 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 | 71805 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |