FDA Adverse Event
Malfunction
Summary report: N
INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM
MDR report key: 798791
·
Received December 14, 2006
Report
- Report Number
- 3004857433-2006-00002
- Event Type
- Malfunction
- Date Received
- December 14, 2006
- Date of Event
- November 14, 2006
- Report Date
- December 13, 2006
- Manufacturer
- ACUMEN MEDICAL, INC.
- Product Code
- DQY
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
UPON INVESTIGATION OF THE RETURNED DEVICE, IT WAS FOUND THAT A MICROSCOPIC FRAGMENT OF THE BALLOON (0.7MM) WAS MISSING FROM THE CATHETER. IT IS UNK WHEN THE FRAGMENT DISLODGED FROM THE CATHETER. THE PT DID NOT EXPERIENCE ADVERSE CLINICAL SEQUELAE DUE TO THE MISSING FRAGMENT OF BALLOON MATERIAL.
Description of Event or Problem · 1
THE CSVS DEVICE WAS INTRODUCED THROUGH AN ATTAIN SHEATH WITH A PRESSURE PRODUCTS VALVE AFTER UNEVENTFUL DEVICE PREPARATION. THE BALLOON WAS INFLATED, BUT DEFLATED ALMOST IMMEDIATELY. THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS USED TO COMPLETE THE CASE WITHOUT INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM | CATHETER, PERCUTANEOUS | DQY | ACUMEN MEDICAL, INC. | CSVS-7-67-MP | H06-0176 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | THE PT BE TREATED WITH ASPIRIN & CLOPIDOGREL| TO REDUCE THROMBUS FORMATION. BECAUSE THE PT HAS A| WITH WARFARIN| LOW EF AND AN LV ANEURISM, HE MAY ALSO BE TREATED |