FDA Adverse Event
Malfunction
Summary report: N
8F ZUMA JR40
MDR report key: 217983
·
Received April 7, 1999
Report
- Report Number
- 1220452-1999-00018
- Event Type
- Malfunction
- Date Received
- April 7, 1999
- Date of Event
- March 12, 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 THE PROCEDURE AS THE PHYSICIAN ATTEMPTED THE PLACEMENT OF THE GUIDE CATHETER HE EXPERIENCED DIFFICULTY IN ADVANCING THE GUIDE OVER THE AORTIC ARCH. REPORTEDLY AT THIS TIME A DISSECTION OF THE AORTA OCCURRED AND THE PROCEDURE WAS STOPPED. 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 |