FDA Adverse Event
Malfunction
Summary report: N
HS III PROXIMAL SEAL SYSTEM 3.8MM
MDR report key: 2802660
·
Received October 19, 2012
Report
- Report Number
- 2242352-2012-01093
- Event Type
- Malfunction
- Date Received
- October 19, 2012
- Date of Event
- September 20, 2012
- Report Date
- September 26, 2012
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- DXC
- PMA / PMN Number
- K080169
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE DEVICES HAVE BEEN RETURNED TO THE FACTORY AND ARE BEING EVALUATED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE EVALUATIONS ARE COMPLETED. A LOT HISTORY RECORD REVIEW WAS COMPLETED FOR EACH OF THE REPORTED PRODUCT LOT NUMBERS. THERE WERE NO NON-CONFORMANCES RECORDED IN THE LOT HISTORIES. (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, TWO HEARTSTRING III DEVICES FAILED TO LOAD PROPERLY. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HS III PROXIMAL SEAL SYSTEM 3.8MM | CLAMPLESS BEATING HEART | DXC | MAQUET CARDIOVASCULAR, LLC | HSK-3038 | 25060980 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |