FDA Adverse Event
Malfunction
Summary report: N
HS III PROXIMAL SEAL SYTEM 4.3MM
MDR report key: 2161687
·
Received June 13, 2011
Report
- Report Number
- 2242352-2010-03398
- Event Type
- Malfunction
- Date Received
- June 13, 2011
- Date of Event
- October 22, 2010
- Report Date
- October 22, 2010
- Manufacturer
- MAQUET CARDIOVASCULAR
- Product Code
- DXC
- PMA / PMN Number
- K080169
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION, THEREFORE NO EVAL COULD BE PERFORMED. INTERNAL FILE NUMBER - (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III ACTIVATION BUTTON WAS ALREADY PRESSED BEFORE LOADING UPON OPENING THE BOX. A NEW KIT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PT EFFECTS. THE PRODUCT IS RETURNING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HS III PROXIMAL SEAL SYTEM 4.3MM | CLAMPLESS BEATING HEART SYSTEM | DXC | MAQUET CARDIOVASCULAR | HSK-3043 | 25010520 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |