FDA Adverse Event
Malfunction
Summary report: N
ACUMEN CORONARY SINUS VISUALIZATION SYSTEM
MDR report key: 635519
·
Received June 11, 2005
Report
- Report Number
- 3004857433-2005-00001
- Event Type
- Malfunction
- Date Received
- June 11, 2005
- Date of Event
- May 25, 2005
- Report Date
- June 10, 2005
- Manufacturer
- ACUMEN MEDICAL, INC.
- Product Code
- DQY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
THE PHYSICIAN WITHDREW THE DEVICE THORUGH THE INTRODUCER SHEATH WITHOUT FIRST HAVING COMPLETELY DEFLATED THE BALLOON (AS DESCRIBED IN THE INFTRUCTIONS FOR USE). THE BALLOON POPPED AS IT WAS WITHDRAWN THROUGH THE SHEATH. UPON INSPECTION, IT WAS FOUND THAT A PEICE OF THE SILICONE BALLOON (APPROXIMATELY 0.5MM X 3MM) WAS MISSING. THE PHYSICIAN WAS APPRISED OF THE MISSING MATERIAL AND CHOSE TO CONTINUE THE PROCEDURE WITHOUT INTERVENTION. THE PATIENT DID NOT EXPERIENCE ADVERSE CLINICAL SEQUELAE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACUMEN CORONARY SINUS VISUALIZATION SYSTEM | PERCUTANEOUS CATHETER | DQY | ACUMEN MEDICAL, INC. | CSVS-08-60 | H05-0038 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR |