FDA Adverse Event
Injury
Summary report: N
ATHEROCATH-GTO CORONARY ATHERECTOMY CATHETER
MDR report key: 48642
·
Received November 8, 1996
Report
- Report Number
- 2027891-1996-00005
- Event Type
- Injury
- Date Received
- November 8, 1996
- Date of Event
- October 14, 1996
- Report Date
- November 8, 1996
- Manufacturer
- ADVANCED CARDIOVASCULAR SYSTEMS, INC.
- Product Code
- MCX
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
AFTER A DIRECTIONAL CORONARY ARTHRECTOMY PROCEDURE THE BALLOON RUPTURED AND A DISSECTION OF THE LEFT ANTERIOR DESCENDING ARTERY OCCURRED. THE PHYSICIAN STATED HE MAY HAVE EXCEEDED THE RATED BURST PRESSURE. THE DISSECTION WAS TREATED SUCCESSFULLY WITH A PERFUSION DILATION CATHETER. THE PT ALSO REQUIRED A PERICARDIOCENTESIS TO ALLEVIATE A CARDIAC TAMPONADE. THE PT WAS DISCHARGED HOME FOUR DAYS POST PROCEDURE. HOSPITAL HAS DISCARDED DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ATHEROCATH-GTO CORONARY ATHERECTOMY CATHETER | ATHRECTOMY DEVICES | MCX | ADVANCED CARDIOVASCULAR SYSTEMS, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Required Intervention |