FDA Adverse Event
Injury
Summary report: N
SPECTROSCOPIC GUIDEWIRE
MDR report key: 58165
·
Received December 19, 1996
Report
- Report Number
- 2183611-1996-00001
- Event Type
- Injury
- Date Received
- December 19, 1996
- Date of Event
- April 10, 1996
- Report Date
- December 16, 1996
- Manufacturer
- SPECTRASCIENCE, INC.
- Product Code
- DQX
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
A PT WAS ADMITTED TO THE CARDIAC CATHETERIZATION LAB FOR A PTCA PROCEDURE INVOLVING A DE NOVO LESION OF THE RIGHT CORONARY ARTERY. HAVING MET APPROIPRIATE CRITERIA, THE PT WAS ALSO ENROLLED IN THE SPECTRASCIENCE CLINICAL STUDY TO EVALUATE THE SPECTROSCOPIC DIAGNOSTIC SYSTEM FOR ITS ABILITY TO CHARACTERIZE CORONARY OCCLUSIONS. DURING THE PROCEDURE, THE PT EXPERIENCED A DISSECTION OF A TORTUOUS SEGMENT OF THE DISTAL PORTION OF THE RIGHT CORONARY ARTERY. PHYSICIAN WAS ABLE TO COMPLETE THE ORIGINALLY INTENDED PROCEDURE, AS WELL AS COLLECT THE DATA REQUIRED FOR THE STUDY. THE ADVERSE EVENT DID NOT RESULT IN DEATH, MORBIDITY, OR LASTING SEQUELA. THE PT WAS FOLLOWED CONSERVATIVELY AND SUBSEQUENTLY DISCHARGED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPECTROSCOPIC GUIDEWIRE | 0.014" CORONARY GUIDEWIRE | DQX | SPECTRASCIENCE, INC. | DG2180 | 01-061092 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Required Intervention | PTCA CATHETERS: MEDTRONIC GOLD-X 2.0 & 1.5 ACE 2.0| GUIDE CATHETERS: MEDTRONIC JR-4 8F, ALI.5 6F. |