FDA Adverse Event
Injury
Summary report: N
CROSSSAIL CORONARY DILATATION CATHETER
MDR report key: 553478
·
Received November 3, 2004
Report
- Report Number
- 2024168-2004-00409
- Event Type
- Injury
- Date Received
- November 3, 2004
- Date of Event
- October 6, 2004
- Report Date
- October 7, 2004
- Manufacturer
- GUIDANT VASCULAR INTERVENTION
- Product Code
- LOX
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BU
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING PRE-DILATION OF A HEAVILY STENOSED MID RCA, UPON THE FIRST INFLATION OF THE BALLOON AT 12 ATM, THERE WAS A RUPTURE WITH SOME AIR EMBOLI. THE PATIENT EXPERIENCED A ST-DEPRESSION, CHEST PAIN AND ELEVATION OF CPK. THE PATIENT WAS THEN STENTED WITH 0% STENOSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CROSSSAIL CORONARY DILATATION CATHETER | CORONARY DILATATION CATHETER | LOX | GUIDANT VASCULAR INTERVENTION | NA | 3121951 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention | DILATATION CATHETER: CROSSSAIL, GUIDE WIRE CORDIS,| GUIDING CATHETER: VIKING 6F, STENT: MEDTRONIK. |