FDA Adverse Event
Malfunction
Summary report: N
HS II PROXIMAL SEAL SYTEM 3.8MM
MDR report key: 2152394
·
Received June 24, 2011
Report
- Report Number
- 2242352-2011-00681
- Event Type
- Malfunction
- Date Received
- June 24, 2011
- Date of Event
- May 26, 2011
- Report Date
- May 31, 2011
- Manufacturer
- MAQUET CARDIOVASCULAR, LLC
- Product Code
- DXC
- PMA / PMN Number
- K080169
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INVESTIGATION: THE PRODUCT WILL NOT BE RETURNED TO MAQUET FOR INVESTIGATION. THEREFORE, A DEVICE EVALUATION COULD NOT BE PERFORMED. A LOT HISTORY RECORD REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN. INTERNAL FILE NUMBER - (B)(4).
Description of Event or Problem · 1
THE HOSPITAL REPORTED THAT DURING PREPARATION FOR A CORONARY ARTERY BYPASS PROCEDURE, THE HEARTSTRING III SEAL WOULDN'T LOAD PROPERLY. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS. THE PRODUCT WAS DISCARDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HS II PROXIMAL SEAL SYTEM 3.8MM | PROXIMAL SEAL | DXC | MAQUET CARDIOVASCULAR, LLC | HSK-3038 | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |