FDA Adverse Event
Malfunction
Summary report: N
ACS OTW LIFESTREAM CORONARY DILATATION CATHETER
MDR report key: 47952
·
Received September 24, 1996
Report
- Report Number
- 2024168-1996-00007
- Event Type
- Malfunction
- Date Received
- September 24, 1996
- Date of Event
- July 31, 1996
- Report Date
- September 24, 1996
- Manufacturer
- ADVANCED CARDIOVASCULAR SYSTEMS, INC.
- Product Code
- LOX
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
DURING REMOVAL OF THE CATHETER FROM THE DISPENSER, THE TIP DETACHED. NO PT INJURY WAS REPORTEDLY ASSOCIATED WITH THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACS OTW LIFESTREAM CORONARY DILATATION CATHETER | CORONARY DILATATION CATHETER | LOX | ADVANCED CARDIOVASCULAR SYSTEMS, INC. | NA | 5110651 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |